Respiratory Sinus ArrhythmiaNCT07922161
Smartphone Camera Measurement of Breathing-Related Heart Rate Variability Compared With ECG in Healthy Adults
A study testing Smartphone simultaneous facial and fingertip photoplethysmography (research app) and Audio-guided paced breathing in people with Respiratory Sinus Arrhythmia and Heart Rate Variability, run by BELL Therapeutics Inc. at 1 site in South Korea.
Trial summary
This study examines how accurately a smartphone can measure the rhythmic rise and fall of heart rate that occurs with breathing (respiratory heart rate variability). Healthy adult volunteers attend one laboratory visit of about 90 minutes in Seoul, Republic of Korea. Read more about this study
- Who is it for?
- Ages 19 to 39 yearsHealthy volunteers can take part
- Conditions the study is for
- Respiratory Sinus Arrhythmia, Heart Rate Variability, Healthy Volunteers
- What is being tested?
- Smartphone simultaneous facial and fingertip photoplethysmography (research app) and Audio-guided paced breathing
- Type of treatment
- Medical device, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 36 participants
- Where
- 1 siteSouth Korea
- Study dates
- 23 Nov 2026to 18 Dec 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 19 to 39 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Adults aged 19 to 39 years
- Able to understand the study explanation and give written informed consent
- Able to remain seated for about 90 minutes and to follow audio-guided breathing at rates as slow as 4 breaths per minute
Who cannot join
- Diagnosed cardiac arrhythmia or conduction disorder (for example, atrial fibrillation)
- Implanted cardiac pacemaker or implantable cardioverter-defibrillator
- Current cardiopulmonary symptoms (for example, chest pain, shortness of breath or palpitations)
- Any condition that, in the investigator's judgment, makes slow paced breathing unsafe or uncomfortable
- Skin lesion, wound or dressing on the measured fingertip or on the facial measurement area
- Severe hand tremor that makes it difficult to keep a fingertip still
- Participants are not asked to stop any medication for this study; current medications are recorded.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Accuracy of Simultaneous Smartphone Facial Remote Photoplethysmography and Fingertip Contact Photoplethysmography for Measuring Respiratory Heart Rate Variability Against Electrocardiography Across Paced Breathing Rates in Healthy Adults: A Single-Visit Method-Comparison Study
This study examines how accurately a smartphone can measure the rhythmic rise and fall of heart rate that occurs with breathing (respiratory heart rate variability).
Healthy adult volunteers attend one laboratory visit of about 90 minutes in Seoul, Republic of Korea. While seated, each participant breathes freely for 5 minutes, then follows audio-guided breathing at seven slow rates between 4 and 7 breaths per minute in random order and finally at 15 breaths per minute, with 2-minute rests between conditions (31 minutes of recording and 16 minutes of rest). During every condition, a single iPhone measures the face with its front camera (contact-free measurement) and a fingertip lightly placed over its rear camera lens (contact measurement) at the same time; no video is stored. A chest ECG and a respiratory belt record continuously throughout the session as references.
Read more
The main question is how closely the breathing-related heart rate variability amplitude measured from the face agrees with the ECG during slow paced breathing. The study also compares the fingertip measurement with the ECG, reports how often the smartphone measurements fail to produce a usable value, evaluates standard heart rate variability measures, and explores whether shorter recordings would give similar agreement and how breathing rate affects agreement.
The smartphone app is a research prototype used only for data collection. This study does not test a treatment, and its measurements are not used to diagnose or treat participants.
Read the detailed description
Design
Single-visit, single-group, within-participant method-comparison study. Each participant completes nine breathing conditions:
- Free breathing without pacing, 5 minutes (always first)
- Paced breathing at 4.0, 4.5, 5.0, 5.5, 6.5 and 7.0 breaths/min, 3 minutes each, and at 6.0 breaths/min, 5 minutes (participant-specific randomized order)
- Paced breathing at 15.0 breaths/min, 3 minutes (always last)
Pacing uses audio cues with an inhalation:exhalation time ratio of 4:6 at a comfortable depth, without breath holding. Conditions are separated by rests of at least 2 minutes, during which the fingertip is lifted and the cameras and flashlight are stopped. Planned recording time is 31 minutes plus 16 minutes of rest (47 minutes). Consent, sensor setup, at least 5 minutes of seated rest before recording, countdowns, data checks and a short questionnaire are additional; the visit lasts about 90 minutes. Participants are asked to avoid alcohol and strenuous exercise for 24 hours and caffeine, smoking and meals for 2 hours before recording. If these are not met, recording starts later or the visit is rescheduled; the times are recorded, and no participant is excluded on this basis after recording has started.
Order of conditions
The order of the seven slow rates is generated for each assignment number with a fixed random seed and stored before the participant's visit, balancing the position of each rate across participants as far as possible. The order is not changed after data are viewed. Free breathing is always first so that it is recorded before any paced breathing, and 15 breaths/min is always last so that faster breathing does not precede the slow rates. Differences between these two conditions and the slow rates may therefore include order and time effects; for 15 breaths/min these include carry-over from slow breathing and fatigue late in the session.
Measurements
A single iPhone 17 Pro running a research data-collection app uses the front camera (face) and the rear main camera (fingertip) simultaneously on a shared device clock. The fingertip is placed lightly over the rear camera lens while the flashlight beside the lens stays on and uncovered. No video from either camera is stored. For the face, the app continuously tracks regions on both cheeks and converts them into region-averaged signals. For every frame, the app saves the timestamp, the mean color values of the measurement regions, the detected face position and the camera settings, together with the extracted signals, beat candidates, device events and the time of every breathing cue. Further processing (beat detection, fiducial points and delay correction) follows an analysis specification frozen before the first participant is enrolled. A chest ECG (reference for beat timing) and a respiratory belt (reference for breathing rate and phase, and for adherence to pacing) record continuously from before the first condition until after the last. Start and end synchronization events are recorded to align the smartphone with the reference devices. Device model, app build and camera settings are fixed before the first participant is enrolled.
Analysis principles
- The participant is the unit of analysis. The conditions are repeated measurements within participants, not independent samples.
- Respiratory heart rate variability amplitude (A_pp, ms) is estimated separately for each sensor from inter-beat intervals (IBI) in the same time window by least-squares fitting of IBI(t) = mu + c*t + a*sin(phi(t)) + b*cos(phi(t)), where phi(t) is the phase of the guided breathing cycle, and A_pp = 2*sqrt(a^2 + b^2). A_pp is the peak-to-peak amplitude of the first harmonic at the guided frequency; it is not identical to every definition of respiratory sinus arrhythmia. No paced amplitude is assigned to free breathing.
- The signals saved by the app are processed offline with a pipeline whose code version, analysis windows, quality rules and failure definitions are fixed before evaluation data are analyzed. No enrolled participant is reassigned to a development set.
- All attempted recordings are retained. Loss of fingertip contact, loss of the face from the camera view or low signal quality counts as measurement failure and is not removed. Participants are not selected on the basis of sensor signal quality. ECG segments unsuitable as a reference are reported separately from sensor failures. A supplementary recording never replaces the original attempt: the primary analysis uses the original attempts, supplementary recordings are reported separately, and original attempts affected by contamination or technical problems are reported with the reason.
- Agreement is summarized by bias and repeated-measures 95% limits of agreement with participant-level confidence intervals; correlation alone is not used to judge agreement. Acceptable agreement and failure-rate limits are specified before evaluation data are analyzed; without such limits, results are reported as descriptive accuracy estimates without claims of equivalence or sufficiency.
- The primary analysis window is 60-180 s after the start of each 3-minute condition and 60-300 s after the start of each 5-minute condition (free breathing and 6.0 breaths/min); the first 60 seconds are excluded as a conservative settling period. Whether conditions could be shortened, by excluding less of the start or by analyzing a shorter recording, is examined in exploratory secondary analyses and does not change the primary windows.
- Analyses of alternative processing, shorter settling periods or recordings, and the breathing rate with maximal amplitude are labelled exploratory.
- Supplementary results, which are not separate outcome measures, include amplitude agreement expressed as absolute error in ms, results for each breathing rate, measurement failure among conditions with an eligible ECG reference, the proportion of valid recording time, RMSSD and SDNN agreement during the paced conditions, the movement of the detected face within each condition, and, among unmatched beats, the share that are displaced in time rather than absent or added.
Questionnaire
After all nine conditions, participants complete a short study-specific questionnaire once; it is not a validated instrument. Six items are rated from 0 to 10 for the average experience of the visit: difficulty keeping the face within the camera view, difficulty keeping the fingertip on the rear camera, fingertip discomfort, fingertip warmth or heat, being bothered by having the face filmed, and difficulty following the audio guide. For each method separately, participants then rate their satisfaction with the method as experienced that day (7-point item) and report any inconvenience. They are then handed the smartphone used in the session, may handle it as they like, and rate for each method how much they would want to use it alone for 5 minutes every night at home before bed (7-point items); they then choose the one method they would use (face, fingertip, or no preference), give the reason, and add suggestions. Face and fingertip items are presented in one of two orders (face first or fingertip first), assigned to each participant in advance from a random allocation table in blocks of four; 'no preference' is always the last option. The two difficulty ratings, their within-participant difference and the chosen method are outcome measures; the other items are reported descriptively. Items are analyzed separately without a total score, and missing responses are not imputed.
Sample size
The target is at least 20 evaluable participants, and up to 36 may be enrolled. Enrollment beyond 20 is intended to narrow the confidence intervals of the bias and limits of agreement and to allow for withdrawal or unusable reference recordings. The final number is determined by the recruitment and measurement schedule and budget, not by interim results: agreement is not analyzed before data collection ends, and checks during the study are limited to data completeness and recording integrity. All evaluable participants are analyzed; no subset is selected. The target of 20 reflects feasibility and is not derived from a power or precision calculation, because the variability and acceptable limits are not yet established.
Scope
Test-retest reliability, treatment effects of slow breathing, and confirmation of a physiological resonance frequency are outside the scope of this study.
- Being tested
- Smartphone simultaneous facial and fingertip photoplethysmography (research app), Audio-guided paced breathing
- Keywords
- Photoplethysmography, Remote Photoplethysmography, Smartphone, Paced Breathing, Slow Breathing, Electrocardiography, Method Comparison, Resonance Frequency Breathing
- Medical subject headings
- Arrhythmia, Sinus, Hypoventilation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Smartphone simultaneous facial and fingertip photoplethysmography (research app)Device
Research-prototype iOS data-collection app on a single iPhone 17 Pro. The front camera measures the face for contact-free remote photoplethysmography; the rear main camera, with the flashlight on, measures a fingertip lightly placed over the lens for contact photoplethysmography. No video is stored; the app tracks both cheek regions and saves region-averaged signals with frame timestamps for later analysis. The app plays the breathing guide. It is not used for diagnosis, and readings shown during recording are not used as study results.
Audio-guided paced breathingBehavioural
Fixed-rate audio cues at 15.0 and at 4.0, 4.5, 5.0, 5.5, 6.0, 6.5 and 7.0 breaths/min, with inhalation taking 40% and exhalation 60% of each cycle, at a comfortable depth without breath holding. A free-breathing condition without cues is included. Participants may rest or stop at any time.
| Study group | Role | What they receive |
|---|---|---|
| Smartphone and Reference Measurement During Free and Paced Breathing | Experimental | Single group. Each participant completes free breathing (5 min), then paced breathing at 4.0, 4.5, 5.0, 5.5, 6.5 and 7.0 breaths/min (3 min each) and 6.0 breaths/min (5 min) in randomized order, and finally paced breathing at 15 breaths/min (3 min), with 2-minute rests. Throughout each condition the face and fingertip are measured simultaneously by one smartphone, while a chest ECG and a respiratory belt record continuously as references. Receives: Device: Smartphone simultaneous facial and fingertip photoplethysmography (research app); Behavioral: Audio-guided paced breathing |
What is being measured
The primary outcome is the main question the study is designed to answer.
Log Ratio of Facial Remote Photoplethysmography to ECG Respiratory Heart Rate Variability Amplitude During Slow Paced Breathing
ln(A_pp face / A_pp ECG) for each slow paced-breathing condition (4.0, 4.5, 5.0, 5.5, 6.0, 6.5 and 7.0 breaths/min). A_pp is the peak-to-peak amplitude (ms) of the first harmonic of inter-beat intervals at the guided breathing frequency, estimated separately for the face and the ECG within the same window (60-180 s after the start of each 3-minute condition and 60-300 s for the 5-minute 6.0 breaths/min condition). Unit: natural-log ratio (unitless; 0 means no difference); +0.1 means a facial amplitude about 10% larger than the ECG amplitude. The reported value is the bias, the mean log ratio pooled across participants and the seven rates, with repeated-measures 95% limits of agreement and participant-level confidence intervals. Conditions without a valid facial estimate are counted in the facial measurement failure outcome.
Measured: Seven slow paced-breathing conditions (3 minutes each; 6.0 breaths/min 5 minutes) during a single study visit (Day 1)
Secondary outcomes (16)
Log Ratio of Fingertip Contact Photoplethysmography to ECG Respiratory Heart Rate Variability Amplitude During Slow Paced Breathing
ln(A_pp fingertip / A_pp ECG), with A_pp, analysis windows and summary defined as in the primary outcome: the bias pooled across participants and the seven slow rates, with repeated-measures 95% limits of agreement and participant-level confidence intervals. Unit: natural-log ratio (unitless; 0 means no difference). Conditions without a valid fingertip estimate are counted in the fingertip measurement failure outcome.
Measured: Seven slow paced-breathing conditions during a single study visit (Day 1)
Within-Participant Difference Between Facial-to-ECG and Fingertip-to-ECG Absolute Log Ratios of Respiratory Heart Rate Variability Amplitude During Slow Paced Breathing
For each participant, |ln(A_pp face / A_pp ECG)| minus |ln(A_pp fingertip / A_pp ECG)| in the same window, averaged over the slow paced-breathing conditions in which both sensors give a valid estimate. Unit: natural-log ratio (unitless); positive values mean a larger facial error. The reported value is the mean across participants with a participant-level 95% confidence interval. Each sensor is also compared with the ECG separately, because agreement between face and fingertip does not imply agreement with the ECG.
Measured: Seven slow paced-breathing conditions during a single study visit (Day 1)
Percentage of Attempted Conditions Without a Valid Facial Estimate
Percentage of all originally attempted breathing conditions, pooled across participants, in which the facial pathway yields no valid estimate under the quality rules fixed before evaluation data are analyzed. The denominator is every attempted condition, including conditions whose ECG is unsuitable as a reference. Failed conditions are not removed, and the reason for each failure is reported.
Measured: All nine conditions during a single study visit (Day 1)
Percentage of Attempted Conditions Without a Valid Fingertip Estimate
Percentage of all originally attempted breathing conditions, pooled across participants, in which the fingertip pathway yields no valid estimate under the quality rules fixed before evaluation data are analyzed. The denominator is every attempted condition, including conditions whose ECG is unsuitable as a reference. Failed conditions are not removed, and the reason for each failure is reported.
Measured: All nine conditions during a single study visit (Day 1)
Percentage of ECG Beats Without a Matching Facial Pulse Beat (Missed Beats)
Percentage of ECG beats (R peaks) in the analysis windows of all originally attempted conditions, including conditions counted as measurement failures, for which no facial pulse beat is detected within 150 ms of the R peak after the median delay between the ECG and the pulse signal in that condition is subtracted, with each beat matched at most once; a pulse beat detected but displaced beyond this tolerance leaves its ECG beat unmatched. Results at tolerances of 100 ms and 200 ms are reported as a sensitivity analysis. ECG segments unsuitable as a reference are excluded from the denominator and reported separately. The reported value is the mean of participant-level percentages with a 95% confidence interval. Errors computed only from matched beats do not show missed beats.
Measured: Analysis windows of all nine conditions during a single study visit (Day 1)
Percentage of ECG Beats Without a Matching Fingertip Pulse Beat (Missed Beats)
Percentage of ECG beats (R peaks) in the analysis windows of all originally attempted conditions, including conditions counted as measurement failures, for which no fingertip pulse beat is detected within 150 ms of the R peak after the median delay between the ECG and the pulse signal in that condition is subtracted, with each beat matched at most once; a pulse beat detected but displaced beyond this tolerance leaves its ECG beat unmatched. Results at tolerances of 100 ms and 200 ms are reported as a sensitivity analysis. ECG segments unsuitable as a reference are excluded from the denominator and reported separately. The reported value is the mean of participant-level percentages with a 95% confidence interval. Errors computed only from matched beats do not show missed beats.
Measured: Analysis windows of all nine conditions during a single study visit (Day 1)
Percentage of Facial Pulse Beats Without a Matching ECG Beat (Extra Beats)
Percentage of facial pulse beats detected in the analysis windows of all originally attempted conditions that have no matching ECG beat (spurious beats), using the same one-to-one matching as for missed beats: within 150 ms of the R peak after the median delay between the ECG and the pulse signal in that condition is subtracted, with each beat matched at most once. A beat displaced beyond this tolerance from its ECG beat also counts as unmatched. Results at tolerances of 100 ms and 200 ms are reported as a sensitivity analysis. Beats in ECG segments unsuitable as a reference are excluded and reported separately. The reported value is the mean of participant-level percentages with a 95% confidence interval.
Measured: Analysis windows of all nine conditions during a single study visit (Day 1)
Percentage of Fingertip Pulse Beats Without a Matching ECG Beat (Extra Beats)
Percentage of fingertip pulse beats detected in the analysis windows of all originally attempted conditions that have no matching ECG beat (spurious beats), using the same one-to-one matching as for missed beats: within 150 ms of the R peak after the median delay between the ECG and the pulse signal in that condition is subtracted, with each beat matched at most once. A beat displaced beyond this tolerance from its ECG beat also counts as unmatched. Results at tolerances of 100 ms and 200 ms are reported as a sensitivity analysis. Beats in ECG segments unsuitable as a reference are excluded and reported separately. The reported value is the mean of participant-level percentages with a 95% confidence interval.
Measured: Analysis windows of all nine conditions during a single study visit (Day 1)
Log Ratio of Facial to ECG Root Mean Square of Successive Differences (RMSSD) During Free Breathing
ln(RMSSD face / RMSSD ECG). RMSSD (ms) is computed from facial pulse intervals and from ECG RR intervals in the same window, using only consecutive valid interval pairs. Unit: natural-log ratio (unitless; 0 means no difference). The reported value is the bias (mean across participants) with 95% limits of agreement, for the primary 60-300 s window and, to indicate whether free breathing could be shortened to 3 minutes, for the 60-180 s window of the same recording.
Measured: 5-minute free-breathing condition (60-300 s window, and 60-180 s window for the 3-minute comparison) during a single study visit (Day 1)
Log Ratio of Fingertip to ECG Root Mean Square of Successive Differences (RMSSD) During Free Breathing
ln(RMSSD fingertip / RMSSD ECG). RMSSD (ms) is computed from fingertip pulse intervals and from ECG RR intervals in the same window, using only consecutive valid interval pairs. Unit: natural-log ratio (unitless; 0 means no difference). The reported value is the bias (mean across participants) with 95% limits of agreement, for the primary 60-300 s window and, to indicate whether free breathing could be shortened to 3 minutes, for the 60-180 s window of the same recording.
Measured: 5-minute free-breathing condition (60-300 s window, and 60-180 s window for the 3-minute comparison) during a single study visit (Day 1)
Log Ratio of Facial to ECG Standard Deviation of Normal-to-Normal Intervals (SDNN) During Free Breathing
ln(SDNN face / SDNN ECG). SDNN (ms) is computed from facial pulse intervals and from ECG RR intervals in the same window, using only valid intervals. Unit: natural-log ratio (unitless; 0 means no difference). The reported value is the bias (mean across participants) with 95% limits of agreement, for the primary 60-300 s window and, to indicate whether free breathing could be shortened to 3 minutes, for the 60-180 s window of the same recording.
Measured: 5-minute free-breathing condition (60-300 s window, and 60-180 s window for the 3-minute comparison) during a single study visit (Day 1)
Log Ratio of Fingertip to ECG Standard Deviation of Normal-to-Normal Intervals (SDNN) During Free Breathing
ln(SDNN fingertip / SDNN ECG). SDNN (ms) is computed from fingertip pulse intervals and from ECG RR intervals in the same window, using only valid intervals. Unit: natural-log ratio (unitless; 0 means no difference). The reported value is the bias (mean across participants) with 95% limits of agreement, for the primary 60-300 s window and, to indicate whether free breathing could be shortened to 3 minutes, for the 60-180 s window of the same recording.
Measured: 5-minute free-breathing condition (60-300 s window, and 60-180 s window for the 3-minute comparison) during a single study visit (Day 1)
Log Ratio of Facial to ECG Respiratory Heart Rate Variability Amplitude at 15 Breaths/Min
ln(A_pp face / A_pp ECG) in the 60-180 s window of the 15 breaths/min condition, with A_pp defined as in the primary outcome. Unit: natural-log ratio (unitless; 0 means no difference). The reported value is the bias (mean across participants) with 95% limits of agreement.
Measured: 3-minute 15 breaths/min condition during a single study visit (Day 1)
Log Ratio of Fingertip to ECG Respiratory Heart Rate Variability Amplitude at 15 Breaths/Min
ln(A_pp fingertip / A_pp ECG) in the 60-180 s window of the 15 breaths/min condition, with A_pp defined as in the primary outcome. Unit: natural-log ratio (unitless; 0 means no difference). The reported value is the bias (mean across participants) with 95% limits of agreement.
Measured: 3-minute 15 breaths/min condition during a single study visit (Day 1)
Log Ratio of Facial to ECG Respiratory Heart Rate Variability Amplitude With a Shorter Settling Period or Shorter Recording (Exploratory)
The primary measure, the bias of ln(A_pp face / A_pp ECG) pooled across participants and the seven slow rates, recomputed with less of the start excluded (from 0, 15 or 30 seconds instead of 60 seconds to the end of the third minute) and with fixed 120-second windows starting at 0, 15, 30 and 60 seconds, which correspond to conditions of 2, 2.25, 2.5 and 3 minutes (60-180 s is the primary window). For 6.0 breaths/min the first 3 minutes of the 5-minute recording are used. This separates the effect of the excluded settling period from that of analysis length. Unit: natural-log ratio (unitless; 0 means no difference). Overlapping windows are not treated as independent samples, and a shorter recording is not called sufficient without pre-specified agreement limits.
Measured: 0-180, 15-180 and 30-180 s windows and 120-second windows starting at 0, 15, 30 and 60 s, in the first 3 minutes of the seven slow paced-breathing conditions during a single study visit (Day 1)
Log Ratio of Facial to ECG Respiratory Heart Rate Variability Amplitude at 6.0 Breaths/Min: 3-Minute and 5-Minute Windows
Bias of ln(A_pp face / A_pp ECG) (mean across participants, with 95% limits of agreement) at 6.0 breaths/min from the 60-180 s window, as in a 3-minute condition, and from the 60-300 s primary window of the same recording, to indicate whether this condition could be shortened to 3 minutes. Unit: natural-log ratio (unitless; 0 means no difference). The 3-minute comparison is limited to this condition and to free breathing (RMSSD and SDNN outcomes) and is not extended to the other rates.
Measured: 5-minute 6.0 breaths/min condition (60-180 s and 60-300 s windows) during a single study visit (Day 1)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Nov 2026
- Study start23 Nov 2026 (estimated)
- Primary completion18 Dec 2026 (estimated)
- Study completion18 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Respiratory Sinus ArrhythmiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- All participants complete the same nine breathing conditions in one visit while being measured simultaneously by the smartphone (face and fingertip) and by the reference ECG and respiratory belt. Free breathing is always first and 15 breaths/min always last; the order of the seven slow rates (4.0 to 7.0 breaths/min) is randomized for each participant so that breathing rate is not tied to time in session. This within-participant order randomization, like the pre-assigned order of face and fingertip items in the end-of-visit questionnaire, does not allocate participants to different arms.
- Masking
- None (open label)
- Enrolment
- 36 participants (estimated)
Sponsor and investigators
- Lead sponsor
- BELL Therapeutics Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Yoonseob Lim, PhD, Principal investigator, Korea Institute of Science and Technology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07922161
- Sponsor's protocol ID
- BELL-001-HRV-KR
- Other IDs
- KIST-202411-HR-006, RS-2024-00506990
- Status last verified
- Nov 2026
- First submitted
- 27 Oct 2026
- Last updated
- 6 Nov 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Individual participant data will not be shared. No video is stored. The smartphone signals and the sensor recordings (ECG and respiratory belt) are stored only for analysis by the study team and will not be provided to other researchers or organizations.
Study at a glance
From the registry record, last updated by the sponsor on 6 Nov 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Accuracy of Simultaneous Smartphone Facial Remote Photoplethysmography and Fingertip Contact Photoplethysmography for Measuring Respiratory Heart Rate Variability Against Electrocardiography Across Paced Breathing Rates in Healthy Adults: A Single-Visit Method-Comparison Study
- ClinicalTrials.gov ID
- NCT07922161
- Acronym / sponsor ID
- BELL-001-HRV-KR
- Keywords
- Photoplethysmography, Remote Photoplethysmography, Smartphone, Paced Breathing, Slow Breathing, Electrocardiography, Method Comparison, Resonance Frequency Breathing
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 36 participants (estimated)
- Lead sponsor
- BELL Therapeutics Inc.Industry (pharma, biotech, devices)
- Study start
- 23 Nov 2026 (estimated)
- Primary completion
- 18 Dec 2026 (estimated)
- Study completion
- 18 Dec 2026 (estimated)
- First posted
- 6 Nov 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study examines how accurately a smartphone can measure the rhythmic rise and fall of heart rate that occurs with breathing (respiratory heart rate variability).
Healthy adult volunteers attend one laboratory visit of about 90 minutes in Seoul, Republic of Korea. While seated, each participant breathes freely for 5 minutes, then follows audio-guided breathing at seven slow rates between 4 and 7 breaths per minute in random order and finally at 15 breaths per minute, with 2-minute rests between conditions (31 minutes of recording and 16 minutes of rest). During every condition, a single iPhone measures the face with its front camera (contact-free measurement) and a fingertip lightly placed over its rear camera lens (contact measurement) at the same time; no video is stored. A chest ECG and a respiratory belt record continuously throughout the session as references.
The main question is how closely the breathing-related heart rate variability amplitude measured from the face agrees with the ECG during slow paced breathing. The study also compares the fingertip measurement with the ECG, reports how often the smartphone measurements fail to produce a usable value, evaluates standard heart rate variability measures, and explores whether shorter recordings would give similar agreement and how breathing rate affects agreement.
The smartphone app is a research prototype used only for data collection. This study does not test a treatment, and its measurements are not used to diagnose or treat participants.
Detailed description
Design
Single-visit, single-group, within-participant method-comparison study. Each participant completes nine breathing conditions:
- Free breathing without pacing, 5 minutes (always first)
- Paced breathing at 4.0, 4.5, 5.0, 5.5, 6.5 and 7.0 breaths/min, 3 minutes each, and at 6.0 breaths/min, 5 minutes (participant-specific randomized order)
- Paced breathing at 15.0 breaths/min, 3 minutes (always last)
Pacing uses audio cues with an inhalation:exhalation time ratio of 4:6 at a comfortable depth, without breath holding. Conditions are separated by rests of at least 2 minutes, during which the fingertip is lifted and the cameras and flashlight are stopped. Planned recording time is 31 minutes plus 16 minutes of rest (47 minutes). Consent, sensor setup, at least 5 minutes of seated rest before recording, countdowns, data checks and a short questionnaire are additional; the visit lasts about 90 minutes. Participants are asked to avoid alcohol and strenuous exercise for 24 hours and caffeine, smoking and meals for 2 hours before recording. If these are not met, recording starts later or the visit is rescheduled; the times are recorded, and no participant is excluded on this basis after recording has started.
Order of conditions
The order of the seven slow rates is generated for each assignment number with a fixed random seed and stored before the participant's visit, balancing the position of each rate across participants as far as possible. The order is not changed after data are viewed. Free breathing is always first so that it is recorded before any paced breathing, and 15 breaths/min is always last so that faster breathing does not precede the slow rates. Differences between these two conditions and the slow rates may therefore include order and time effects; for 15 breaths/min these include carry-over from slow breathing and fatigue late in the session.
Measurements
A single iPhone 17 Pro running a research data-collection app uses the front camera (face) and the rear main camera (fingertip) simultaneously on a shared device clock. The fingertip is placed lightly over the rear camera lens while the flashlight beside the lens stays on and uncovered. No video from either camera is stored. For the face, the app continuously tracks regions on both cheeks and converts them into region-averaged signals. For every frame, the app saves the timestamp, the mean color values of the measurement regions, the detected face position and the camera settings, together with the extracted signals, beat candidates, device events and the time of every breathing cue. Further processing (beat detection, fiducial points and delay correction) follows an analysis specification frozen before the first participant is enrolled. A chest ECG (reference for beat timing) and a respiratory belt (reference for breathing rate and phase, and for adherence to pacing) record continuously from before the first condition until after the last. Start and end synchronization events are recorded to align the smartphone with the reference devices. Device model, app build and camera settings are fixed before the first participant is enrolled.
Analysis principles
- The participant is the unit of analysis. The conditions are repeated measurements within participants, not independent samples.
- Respiratory heart rate variability amplitude (A_pp, ms) is estimated separately for each sensor from inter-beat intervals (IBI) in the same time window by least-squares fitting of IBI(t) = mu + c*t + a*sin(phi(t)) + b*cos(phi(t)), where phi(t) is the phase of the guided breathing cycle, and A_pp = 2*sqrt(a^2 + b^2). A_pp is the peak-to-peak amplitude of the first harmonic at the guided frequency; it is not identical to every definition of respiratory sinus arrhythmia. No paced amplitude is assigned to free breathing.
- The signals saved by the app are processed offline with a pipeline whose code version, analysis windows, quality rules and failure definitions are fixed before evaluation data are analyzed. No enrolled participant is reassigned to a development set.
- All attempted recordings are retained. Loss of fingertip contact, loss of the face from the camera view or low signal quality counts as measurement failure and is not removed. Participants are not selected on the basis of sensor signal quality. ECG segments unsuitable as a reference are reported separately from sensor failures. A supplementary recording never replaces the original attempt: the primary analysis uses the original attempts, supplementary recordings are reported separately, and original attempts affected by contamination or technical problems are reported with the reason.
- Agreement is summarized by bias and repeated-measures 95% limits of agreement with participant-level confidence intervals; correlation alone is not used to judge agreement. Acceptable agreement and failure-rate limits are specified before evaluation data are analyzed; without such limits, results are reported as descriptive accuracy estimates without claims of equivalence or sufficiency.
- The primary analysis window is 60-180 s after the start of each 3-minute condition and 60-300 s after the start of each 5-minute condition (free breathing and 6.0 breaths/min); the first 60 seconds are excluded as a conservative settling period. Whether conditions could be shortened, by excluding less of the start or by analyzing a shorter recording, is examined in exploratory secondary analyses and does not change the primary windows.
- Analyses of alternative processing, shorter settling periods or recordings, and the breathing rate with maximal amplitude are labelled exploratory.
- Supplementary results, which are not separate outcome measures, include amplitude agreement expressed as absolute error in ms, results for each breathing rate, measurement failure among conditions with an eligible ECG reference, the proportion of valid recording time, RMSSD and SDNN agreement during the paced conditions, the movement of the detected face within each condition, and, among unmatched beats, the share that are displaced in time rather than absent or added.
Questionnaire
After all nine conditions, participants complete a short study-specific questionnaire once; it is not a validated instrument. Six items are rated from 0 to 10 for the average experience of the visit: difficulty keeping the face within the camera view, difficulty keeping the fingertip on the rear camera, fingertip discomfort, fingertip warmth or heat, being bothered by having the face filmed, and difficulty following the audio guide. For each method separately, participants then rate their satisfaction with the method as experienced that day (7-point item) and report any inconvenience. They are then handed the smartphone used in the session, may handle it as they like, and rate for each method how much they would want to use it alone for 5 minutes every night at home before bed (7-point items); they then choose the one method they would use (face, fingertip, or no preference), give the reason, and add suggestions. Face and fingertip items are presented in one of two orders (face first or fingertip first), assigned to each participant in advance from a random allocation table in blocks of four; 'no preference' is always the last option. The two difficulty ratings, their within-participant difference and the chosen method are outcome measures; the other items are reported descriptively. Items are analyzed separately without a total score, and missing responses are not imputed.
Sample size
The target is at least 20 evaluable participants, and up to 36 may be enrolled. Enrollment beyond 20 is intended to narrow the confidence intervals of the bias and limits of agreement and to allow for withdrawal or unusable reference recordings. The final number is determined by the recruitment and measurement schedule and budget, not by interim results: agreement is not analyzed before data collection ends, and checks during the study are limited to data completeness and recording integrity. All evaluable participants are analyzed; no subset is selected. The target of 20 reflects feasibility and is not derived from a power or precision calculation, because the variability and acceptable limits are not yet established.
Scope
Test-retest reliability, treatment effects of slow breathing, and confirmation of a physiological resonance frequency are outside the scope of this study.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- All participants complete the same nine breathing conditions in one visit while being measured simultaneously by the smartphone (face and fingertip) and by the reference ECG and respiratory belt. Free breathing is always first and 15 breaths/min always last; the order of the seven slow rates (4.0 to 7.0 breaths/min) is randomized for each participant so that breathing rate is not tied to time in session. This within-participant order randomization, like the pre-assigned order of face and fingertip items in the end-of-visit questionnaire, does not allocate participants to different arms.
| Arm | Type | Receives |
|---|---|---|
| Smartphone and Reference Measurement During Free and Paced Breathing | Experimental | Device: Smartphone simultaneous facial and fingertip photoplethysmography (research app), Behavioral: Audio-guided paced breathingSingle group. Each participant completes free breathing (5 min), then paced breathing at 4.0, 4.5, 5.0, 5.5, 6.5 and 7.0 breaths/min (3 min each) and 6.0 breaths/min (5 min) in randomized order, and finally paced breathing at 15 breaths/min (3 min), with 2-minute rests. Throughout each condition the face and fingertip are measured simultaneously by one smartphone, while a chest ECG and a respiratory belt record continuously as references. |
Who may qualify
- Ages
- 19 to 39 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Adults aged 19 to 39 years
- Able to understand the study explanation and give written informed consent
- Able to remain seated for about 90 minutes and to follow audio-guided breathing at rates as slow as 4 breaths per minute
Key exclusion criteria (7 listed)
- Diagnosed cardiac arrhythmia or conduction disorder (for example, atrial fibrillation)
- Implanted cardiac pacemaker or implantable cardioverter-defibrillator
- Current cardiopulmonary symptoms (for example, chest pain, shortness of breath or palpitations)
- Any condition that, in the investigator's judgment, makes slow paced breathing unsafe or uncomfortable
- Skin lesion, wound or dressing on the measured fingertip or on the facial measurement area
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Smartphone simultaneous facial and fingertip photoplethysmography (research app)Research-prototype iOS data-collection app on a single iPhone 17 Pro. The front camera measures the face for contact-free remote photoplethysmography; the rear main camera, with the flashlight on, measures a fingertip lightly placed over the lens for contact photoplethysmography. No video is stored; the app tracks both cheek regions and saves region-averaged signals with frame timestamps for later analysis. The app plays the breathing guide. It is not used for diagnosis, and readings shown during recording are not used as study results. | Device | Smartphone and Reference Measurement During Free and Paced Breathing |
| Audio-guided paced breathingFixed-rate audio cues at 15.0 and at 4.0, 4.5, 5.0, 5.5, 6.0, 6.5 and 7.0 breaths/min, with inhalation taking 40% and exhalation 60% of each cycle, at a comfortable depth without breath holding. A free-breathing condition without cues is included. Participants may rest or stop at any time. | Behavioural | Smartphone and Reference Measurement During Free and Paced Breathing |
Primary outcome
Log Ratio of Facial Remote Photoplethysmography to ECG Respiratory Heart Rate Variability Amplitude During Slow Paced Breathing
Time frame: Seven slow paced-breathing conditions (3 minutes each; 6.0 breaths/min 5 minutes) during a single study visit (Day 1)
ln(A_pp face / A_pp ECG) for each slow paced-breathing condition (4.0, 4.5, 5.0, 5.5, 6.0, 6.5 and 7.0 breaths/min). A_pp is the peak-to-peak amplitude (ms) of the first harmonic of inter-beat intervals at the guided breathing frequency, estimated separately for the face and the ECG within the same window (60-180 s after the start of each 3-minute condition and 60-300 s for the 5-minute 6.0 breaths/min condition). Unit: natural-log ratio (unitless; 0 means no difference); +0.1 means a facial amplitude about 10% larger than the ECG amplitude. The reported value is the bias, the mean log ratio pooled across participants and the seven rates, with repeated-measures 95% limits of agreement and participant-level confidence intervals. Conditions without a valid facial estimate are counted in the facial measurement failure outcome.
16 secondary outcomes
Log Ratio of Fingertip Contact Photoplethysmography to ECG Respiratory Heart Rate Variability Amplitude During Slow Paced Breathing
Time frame: Seven slow paced-breathing conditions during a single study visit (Day 1)
Within-Participant Difference Between Facial-to-ECG and Fingertip-to-ECG Absolute Log Ratios of Respiratory Heart Rate Variability Amplitude During Slow Paced Breathing
Time frame: Seven slow paced-breathing conditions during a single study visit (Day 1)
Percentage of Attempted Conditions Without a Valid Facial Estimate
Time frame: All nine conditions during a single study visit (Day 1)
Percentage of Attempted Conditions Without a Valid Fingertip Estimate
Time frame: All nine conditions during a single study visit (Day 1)
Percentage of ECG Beats Without a Matching Facial Pulse Beat (Missed Beats)
Time frame: Analysis windows of all nine conditions during a single study visit (Day 1)
Percentage of ECG Beats Without a Matching Fingertip Pulse Beat (Missed Beats)
Time frame: Analysis windows of all nine conditions during a single study visit (Day 1)
Percentage of Facial Pulse Beats Without a Matching ECG Beat (Extra Beats)
Time frame: Analysis windows of all nine conditions during a single study visit (Day 1)
Percentage of Fingertip Pulse Beats Without a Matching ECG Beat (Extra Beats)
Time frame: Analysis windows of all nine conditions during a single study visit (Day 1)
Log Ratio of Facial to ECG Root Mean Square of Successive Differences (RMSSD) During Free Breathing
Time frame: 5-minute free-breathing condition (60-300 s window, and 60-180 s window for the 3-minute comparison) during a single study visit (Day 1)
Log Ratio of Fingertip to ECG Root Mean Square of Successive Differences (RMSSD) During Free Breathing
Time frame: 5-minute free-breathing condition (60-300 s window, and 60-180 s window for the 3-minute comparison) during a single study visit (Day 1)
Log Ratio of Facial to ECG Standard Deviation of Normal-to-Normal Intervals (SDNN) During Free Breathing
Time frame: 5-minute free-breathing condition (60-300 s window, and 60-180 s window for the 3-minute comparison) during a single study visit (Day 1)
Log Ratio of Fingertip to ECG Standard Deviation of Normal-to-Normal Intervals (SDNN) During Free Breathing
Time frame: 5-minute free-breathing condition (60-300 s window, and 60-180 s window for the 3-minute comparison) during a single study visit (Day 1)
Log Ratio of Facial to ECG Respiratory Heart Rate Variability Amplitude at 15 Breaths/Min
Time frame: 3-minute 15 breaths/min condition during a single study visit (Day 1)
Log Ratio of Fingertip to ECG Respiratory Heart Rate Variability Amplitude at 15 Breaths/Min
Time frame: 3-minute 15 breaths/min condition during a single study visit (Day 1)
Log Ratio of Facial to ECG Respiratory Heart Rate Variability Amplitude With a Shorter Settling Period or Shorter Recording (Exploratory)
Time frame: 0-180, 15-180 and 30-180 s windows and 120-second windows starting at 0, 15, 30 and 60 s, in the first 3 minutes of the seven slow paced-breathing conditions during a single study visit (Day 1)
Log Ratio of Facial to ECG Respiratory Heart Rate Variability Amplitude at 6.0 Breaths/Min: 3-Minute and 5-Minute Windows
Time frame: 5-minute 6.0 breaths/min condition (60-180 s and 60-300 s windows) during a single study visit (Day 1)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Nov 2026.
- Individual participant dataSharing planned: No. Individual participant data will not be shared. No video is stored. The smartphone signals and the sensor recordings (ECG and respiratory belt) are stored only for analysis by the study team and will not be provided to other researchers or organizations.
Related trials for Respiratory Sinus Arrhythmia
Not yet recruiting
Head-to-Head (H2H) Comparison of Ambulatory Cardiac ECG Monitors in Japan
Atrial Fibrillation (AF), Atrial Flutter
Recruiting
Respiratory Sinus Arrhythmia Pacing Post-CABG Surgery in Patients With HFrEF
Heart Failure With Reduced Ejection Fraction
Enrolling by invitation
Effect of Environment on the Central and Peripheral Nervous System
Rumination
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Yoonseob Lim, PhD principal investigator
Korea Institute of Science and Technology
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Smartphone simultaneous facial and fingertip photoplethysmography (research app) and Audio-guided paced breathing in people with Respiratory Sinus Arrhythmia and Heart Rate Variability, run by BELL Therapeutics Inc. at 1 site in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 6 Nov 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Keonseok Lee (+82-10-4330-0422, keonseok.lee@belltherapeutics.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Log Ratio of Facial Remote Photoplethysmography to ECG Respiratory Heart Rate Variability Amplitude During Slow Paced Breathing (time frame: Seven slow paced-breathing conditions (3 minutes each; 6.0 breaths/min 5 minutes) during a single study visit (Day 1)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Nov 2026.