COVID-19NCT05035420
A Noninvasive Multimodal Biosensing Device for Screening and Monitoring Response to Treatment of Infectious Respiratory Diseases
A study testing Fitbit, Douglas Bag and Periflux 6000 EPOS in people with COVID-19 and Upper Respiratory Infection, run by Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) at 1 site in United States.
Trial summary
Background: The COVID-19 outbreak has strained the health care system. New tools are needed for diagnostic testing and monitoring of people who have the virus. Researchers want to test a device they hope can screen, detect, and monitor symptoms linked to respiratory diseases like COVID-19. Read more about this study
- Who is it for?
- Ages 18 to 78 years
- Conditions the study is for
- COVID-19, Upper Respiratory Infection, Lower Respiratory Infection
- What is being tested?
- Fitbit, Douglas Bag and Periflux 6000 EPOS
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteUnited States
- Study dates
- 26 May 2022to 27 Aug 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 18 to 78 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- In order to be eligible to participate in this study, an individual must meet all of the following criteria:
- Provision of signed and dated informed consent form.
- Stated willingness to comply with all study procedures and availability for the duration of the study.
- Male or female aged 18 years or greater.
- In good general health as evidenced by medical history with no signs of cough, sneeze and upper respiratory symptoms.
- Body temperature in normal range (afebrile, temperature < 100.4 (Infinite) F) on the day of the experiment.
Who cannot join
- Any skin disease.
- Fever (Temperature greater than or equal to 100.4 degrees F).
- Any past or present cardiovascular or pulmonary diseases.
- Known adverse reaction to latex.
- Any medical condition that, in the opinion of the Principal Investigator would preclude the inclusion of a patient onto this research study.
- Unable or unwilling to give informed consent.
Show all 11Show fewer
- Individuals with known respiratory conditions.
- Individuals who are currently taking medication that may cause methemoglobinemia such as nitrates derivatives, sulfonamides, dapsone, phenacetin, phenazopyridine, some local anesthetics such as prilocaine, topical anesthetics such as emla cream, benzocaine.
- Individuals with history of seizure.
- Smokers and those on narcotics.
- Pregnant women are excluded due to risk associated to hypercapnia risk
Trial locations and contacts
1 site in 1 country.
United States1 site
National Institutes of Health Clinical Center
Bethesda, Maryland, 20892
About this study
Official title: A Pilot Study to Evaluate A Noninvasive Multimodal Biosensing Device for Screening and Monitoring Response to Treatment of Infectious Respiratory Diseases
Background:
The COVID-19 outbreak has strained the health care system. New tools are needed for diagnostic testing and monitoring of people who have the virus. Researchers want to test a device they hope can screen, detect, and monitor symptoms linked to respiratory diseases like COVID-19.
Read more
Objective:
To evaluate and validate a device that measures breathing, body temperature, heart rate, and tissue oxygenation.
Eligibility:
Healthy adults ages 18 and older with no flu-like symptoms and no current signs of infection, cough, fever, or sneezing.
Design:
Participants will have a physical exam. Their vital signs will be taken.
Participants will sit in a chair. They will be monitored for 60 to 80 minutes while they do the following tasks:
Rest for 10 minutes. They will repeat this after each task.
Hold their breath for up to 2 minutes and then rest for 2 minutes. They will do this task 3 times.
Pace-breathe with breathing rates of 10, 20, and 30 breaths per minute. They will do this task 2 times.
Breathe air that has 5% of carbon dioxide for 5 minutes.
During these tasks, data will be collected and recorded with a pulse oximeter, thermometer, respiratory belt, and spirometer.
Participants will fill out questionnaires related to their daily activity (medication intake, exercise, smoking, and drinking).
Participation will last for 2 to 3 hours.
Read the detailed description
Study Description:<TAB>
This observational pilot study will characterize the performance of a multimodal biosensor device (a portable and a wireless NIRS device, PPG and temperature sensor) in measuring human vital signs, which later will be explored as a point-of-care method for screening and treatment response monitoring of individuals with an infectious respiratory illness. The devices will measure heart, respiratory, and tissue oxygenation parameters in healthy subjects at rest and during induced hypercapnia, breath holding, and paced breathing.
Objectives:
<TAB>
Primary objective: Compare performance of two multimodal NIRS biosensor devices with commercial systems for measuring vital physiological signals including cardiac, respiratory, and tissue oxygenation in individuals at rest.
Secondary objective: Compare measured changes in cardiac, respiratory, and tissue oxygenation parameters during induced hypercapnia, breath holding, and paced breathing exercises between the biosensor and commercial systems.
Exploratory objective: Characterize arterial oxygen saturation (SpO2), peripheral oxygen saturation (StO2) and cerebral oxygen saturation (ScO2) during respiratory perturbations.
Endpoints:<TAB>
Primary endpoint: Paired differences, Lin s concordance correlation coefficient and Bland-Altman analysis for the following parameters: Biosensor tissue microvascular oxygenation level (StO2), respiratory rate (RR), respiratory effort index (REI), heart rate (HR) and heart rate variability (HRV).
Secondary endpoint: Paired differences, Lin s concordance correlation coefficient and Bland-Altman analysis for the following parameters: Biosensor tissue microvascular oxygenation level (StO2), respiratory rate (RR), respiratory effort index (REI), heart rate (HR) and heart rate variability (HRV) during induced hypercapnia, breath holding, and paced breathing exercises.
Exploratory endpoint: Arterial oxygen saturation (SpO2), peripheral oxygen saturation (StO2) and cerebral oxygen saturation (ScO2).
- Being tested
- Fitbit, Douglas Bag, Periflux 6000 EPOS, BIOPAC, Flowmet
- Keywords
- point-of-care multimodal biosensing device, COVID-19 screening and monitoring
- Medical subject headings
- COVID-19, Respiratory Tract Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
FitbitDevice
Performance of the NIRS biosensor will be explored in comparison to this commercial wearable.
Douglas BagDevice
The Douglas Bag will be used for inducing hypercapnia.
Periflux 6000 EPOSDevice
Tissue oxygen saturation measured by the Periflux 6000 will be compared with peripheral tissue saturation measured with the NIRS biosensor both at rest and during the induced hypercapnia, paced breathing and breath holding.
BIOPACDevice
The BIOPAC system will be used to record the PPG signal, cardiovascular hemodynamics, and respiratory parameters in order to noninvasively monitor the heart rate, heart rate variability, respiratory rate, respiratory effort index, and arterial oxygen saturation.
FlowmetDevice
Flowmet will be used for a measurement of arterial blood flow within the finger or toe. Flowmet outputs a PPG waveform that will be compared with the NIRS biosensor.
NIRSDevice
- Each subject will be monitored with the multimodal system for 10 minutes while sitting quiescent on a chair in resting position. All screening index parameters will be collected and recorded. b. Each subject will be studied for approximately 60-80 minutes while being exposed to a mild Hypercapnia (5% CO2), paced breathing and breath holding followed by a 10-minute recovery time after each task.
| Study group | Role | What they receive |
|---|---|---|
| Healthy Volunteer | Experimental | Healthy Volunteer Receives: Device: Fitbit; Device: Douglas Bag; Device: Periflux 6000 EPOS; Device: BIOPAC; Device: Flowmet; Device: NIRS |
What is being measured
The primary outcome is the main question the study is designed to answer.
Compare performance of a multimodal biosensor device with commercial systems for measuring vital physiological signals including cardiac, respiratory, and tissue oxygenation in individuals at rest.
Compare performance of two multimodal NIRS biosensor devices with commercial systems for measuring vital physiological signals including cardiac, respiratory, and tissue oxygenation in individuals at rest.
Measured: End of study
Secondary outcomes (2)
Characterize arterial oxygen saturation (SpO2), peripheral oxygen saturation (StO2) and cerebral oxygen saturation (ScO2) during respiratory perturbations.
We would like to know if arterial oxygen saturation (SpO2), peripheral oxygen saturation (StO2) and cerebral oxygen saturation (ScO2) are also sensitive to respiratory changes. Although these parameters are all related, they may exhibit unique behavior due to autoregulatory mechanisms in the brain and differences between arterial and tissue saturation.
Measured: End of study
Compare measured changes in cardiac, respiratory, and tissue oxygenation parameters during induced hypercapnia, breath holding, and paced breathing exercises between the biosensor and commercial systems.
Accuracy of the biosensor not only depends on comparison to baseline values but also should correlate during induced changes.
Measured: End of study
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Sep 2021
- Study start26 May 2022
- Primary completion27 Aug 2025
- Study completion27 Aug 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for COVID-19Studies 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
- Device feasibility
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
- Sponsor type
- US National Institutes of Health
- Responsible party
- Sponsor
- Investigators
- Amir H Gandjbakhche, Ph.D., Principal investigator, Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05035420
- Sponsor's protocol ID
- 210028
- Other IDs
- 21-CH-0028
- Status last verified
- 3 Sep 2025
- First submitted
- 3 Sep 2021
- Last updated
- 5 Sep 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: We are working on deciding if we will share IPD
Publications
Sakudo A. Near-infrared spectroscopy for medical applications: Current status and future perspectives. Clin Chim Acta. 2016 Apr 1;455:181-8. doi: 10.1016/j.cca.2016.02.009. Epub 2016 Feb 12.
PubMed 26877058Chiu WT, Lin PW, Chiou HY, Lee WS, Lee CN, Yang YY, Lee HM, Hsieh MS, Hu CJ, Ho YS, Deng WP, Hsu CY. Infrared thermography to mass-screen suspected SARS patients with fever. Asia Pac J Public Health. 2005;17(1):26-8. doi: 10.1177/101053950501700107.
PubMed 16044829Abay TY, Kyriacou PA. Reflectance Photoplethysmography as Noninvasive Monitoring of Tissue Blood Perfusion. IEEE Trans Biomed Eng. 2015 Sep;62(9):2187-95. doi: 10.1109/TBME.2015.2417863. Epub 2015 Mar 30.
PubMed 25838515
Study at a glance
From the registry record, last updated by the sponsor on 5 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Pilot Study to Evaluate A Noninvasive Multimodal Biosensing Device for Screening and Monitoring Response to Treatment of Infectious Respiratory Diseases
- ClinicalTrials.gov ID
- NCT05035420
- Acronym / sponsor ID
- 210028
- Keywords
- point-of-care multimodal biosensing device, COVID-19 screening and monitoring
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)US National Institutes of Health
- Study start
- 26 May 2022 (actual)
- Primary completion
- 27 Aug 2025 (actual)
- Study completion
- 27 Aug 2025 (actual)
- First posted
- 5 Sep 2021 (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.
Background:
The COVID-19 outbreak has strained the health care system. New tools are needed for diagnostic testing and monitoring of people who have the virus. Researchers want to test a device they hope can screen, detect, and monitor symptoms linked to respiratory diseases like COVID-19.
Objective:
To evaluate and validate a device that measures breathing, body temperature, heart rate, and tissue oxygenation.
Eligibility:
Healthy adults ages 18 and older with no flu-like symptoms and no current signs of infection, cough, fever, or sneezing.
Design:
Participants will have a physical exam. Their vital signs will be taken.
Participants will sit in a chair. They will be monitored for 60 to 80 minutes while they do the following tasks:
Rest for 10 minutes. They will repeat this after each task.
Hold their breath for up to 2 minutes and then rest for 2 minutes. They will do this task 3 times.
Pace-breathe with breathing rates of 10, 20, and 30 breaths per minute. They will do this task 2 times.
Breathe air that has 5% of carbon dioxide for 5 minutes.
During these tasks, data will be collected and recorded with a pulse oximeter, thermometer, respiratory belt, and spirometer.
Participants will fill out questionnaires related to their daily activity (medication intake, exercise, smoking, and drinking).
Participation will last for 2 to 3 hours.
Detailed description
Study Description:<TAB>
This observational pilot study will characterize the performance of a multimodal biosensor device (a portable and a wireless NIRS device, PPG and temperature sensor) in measuring human vital signs, which later will be explored as a point-of-care method for screening and treatment response monitoring of individuals with an infectious respiratory illness. The devices will measure heart, respiratory, and tissue oxygenation parameters in healthy subjects at rest and during induced hypercapnia, breath holding, and paced breathing.
Objectives:
<TAB>
Primary objective: Compare performance of two multimodal NIRS biosensor devices with commercial systems for measuring vital physiological signals including cardiac, respiratory, and tissue oxygenation in individuals at rest.
Secondary objective: Compare measured changes in cardiac, respiratory, and tissue oxygenation parameters during induced hypercapnia, breath holding, and paced breathing exercises between the biosensor and commercial systems.
Exploratory objective: Characterize arterial oxygen saturation (SpO2), peripheral oxygen saturation (StO2) and cerebral oxygen saturation (ScO2) during respiratory perturbations.
Endpoints:<TAB>
Primary endpoint: Paired differences, Lin s concordance correlation coefficient and Bland-Altman analysis for the following parameters: Biosensor tissue microvascular oxygenation level (StO2), respiratory rate (RR), respiratory effort index (REI), heart rate (HR) and heart rate variability (HRV).
Secondary endpoint: Paired differences, Lin s concordance correlation coefficient and Bland-Altman analysis for the following parameters: Biosensor tissue microvascular oxygenation level (StO2), respiratory rate (RR), respiratory effort index (REI), heart rate (HR) and heart rate variability (HRV) during induced hypercapnia, breath holding, and paced breathing exercises.
Exploratory endpoint: Arterial oxygen saturation (SpO2), peripheral oxygen saturation (StO2) and cerebral oxygen saturation (ScO2).
Study design
- Primary purpose
- Device feasibility
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Healthy Volunteer | Experimental | Device: Fitbit, Device: Douglas Bag, Device: Periflux 6000 EPOS, Device: BIOPAC, Device: Flowmet, Device: NIRSHealthy Volunteer |
Who may qualify
- Ages
- 18 to 78 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- In order to be eligible to participate in this study, an individual must meet all of the following criteria:
- Provision of signed and dated informed consent form.
- Stated willingness to comply with all study procedures and availability for the duration of the study.
- Male or female aged 18 years or greater.
- In good general health as evidenced by medical history with no signs of cough, sneeze and upper respiratory symptoms.
Key exclusion criteria (11 listed)
- Any skin disease.
- Fever (Temperature greater than or equal to 100.4 degrees F).
- Any past or present cardiovascular or pulmonary diseases.
- Known adverse reaction to latex.
- Any medical condition that, in the opinion of the Principal Investigator would preclude the inclusion of a patient onto this research study.
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 |
|---|---|---|
| FitbitPerformance of the NIRS biosensor will be explored in comparison to this commercial wearable. | Device | Healthy Volunteer |
| Douglas BagThe Douglas Bag will be used for inducing hypercapnia. | Device | Healthy Volunteer |
| Periflux 6000 EPOSTissue oxygen saturation measured by the Periflux 6000 will be compared with peripheral tissue saturation measured with the NIRS biosensor both at rest and during the induced hypercapnia, paced breathing and breath holding. | Device | Healthy Volunteer |
| BIOPACThe BIOPAC system will be used to record the PPG signal, cardiovascular hemodynamics, and respiratory parameters in order to noninvasively monitor the heart rate, heart rate variability, respiratory rate, respiratory effort index, and arterial oxygen saturation. | Device | Healthy Volunteer |
| FlowmetFlowmet will be used for a measurement of arterial blood flow within the finger or toe. Flowmet outputs a PPG waveform that will be compared with the NIRS biosensor. | Device | Healthy Volunteer |
| NIRSa. Each subject will be monitored with the multimodal system for 10 minutes while sitting quiescent on a chair in resting position. All screening index parameters will be collected and recorded. b. Each subject will be studied for approximately 60-80 minutes while being exposed to a mild Hypercapnia (5% CO2), paced breathing and breath holding followed by a 10-minute recovery time after each task. | Device | Healthy Volunteer |
Primary outcome
Compare performance of a multimodal biosensor device with commercial systems for measuring vital physiological signals including cardiac, respiratory, and tissue oxygenation in individuals at rest.
Time frame: End of study
Compare performance of two multimodal NIRS biosensor devices with commercial systems for measuring vital physiological signals including cardiac, respiratory, and tissue oxygenation in individuals at rest.
2 secondary outcomes
Characterize arterial oxygen saturation (SpO2), peripheral oxygen saturation (StO2) and cerebral oxygen saturation (ScO2) during respiratory perturbations.
Time frame: End of study
Compare measured changes in cardiac, respiratory, and tissue oxygenation parameters during induced hypercapnia, breath holding, and paced breathing exercises between the biosensor and commercial systems.
Time frame: End of study
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Sep 2025.
- Background: PubMed 26877058Sakudo A. Near-infrared spectroscopy for medical applications: Current status and future perspectives. Clin Chim Acta. 2016 Apr 1;455:181-8. doi: 10.1016/j.cca.2016.02.009. Epub 2016 Feb 12.
- Background: PubMed 16044829Chiu WT, Lin PW, Chiou HY, Lee WS, Lee CN, Yang YY, Lee HM, Hsieh MS, Hu CJ, Ho YS, Deng WP, Hsu CY. Infrared thermography to mass-screen suspected SARS patients with fever. Asia Pac J Public Health. 2005;17(1):26-8. doi: 10.1177/101053950501700107.
- Background: PubMed 25838515Abay TY, Kyriacou PA. Reflectance Photoplethysmography as Noninvasive Monitoring of Tissue Blood Perfusion. IEEE Trans Biomed Eng. 2015 Sep;62(9):2187-95. doi: 10.1109/TBME.2015.2417863. Epub 2015 Mar 30.
- NIH Clinical Center Detailed Web PageLink provided by the sponsor.
- Individual participant dataSharing planned: Undecided. We are working on deciding if we will share IPD
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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. This study is not recruiting at the moment.
Amir H Gandjbakhche, Ph.D. principal investigator
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Fitbit, Douglas Bag and Periflux 6000 EPOS in people with COVID-19 and Upper Respiratory Infection, run by Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) at 1 site in United States.
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 6 inclusion and 11 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: finished, as of the sponsor's last update on 5 Sep 2025. 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 United States. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Compare performance of a multimodal biosensor device with commercial systems for measuring vital physiological signals including cardiac, respiratory, and tissue oxygenation in individuals at rest. (time frame: End of study). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05035420, which also lists 3 linked publications.
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 5 Sep 2025.