Healthy AdultNCT07908199
Oura Ring OA15 Validation
An observational study of Healthy Adult and Sleep Apnea, run by Ouraring Inc. at 1 site in United States.
Trial summary
The current study intends to collect data from Oura Ring time-locked to ground truth medical sleep diagnostic gold-standard polysomnography (PSG) for product research and development, investigational algorithm validation, and scientific dissemination. Read more about this study
- Who is it for?
- Ages 18 to 85 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy Adult, Sleep Apnea
- Type of treatment
- Pill or oral medicine
- How many people
- 60 participants
- Where
- 1 siteUnited States
- Study dates
- 28 Aug 2026to 31 Jan 2027
- Phase
- Observational
- 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 18 to 85 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: The study population will be composed of adults in the general population in the St. Louis area, including patients from the clinic database and general community.
Who may be able to join
- Ages 18-85 y
- Body mass index (BMI) <30 kg/m2
- Self-reported habitual sleep duration of 6-9 hours
- Willing and able to comply with the study requirements
Who cannot join
- High risk for mild-to-severe sleep apnea
- Individuals with pacemakers
- Non-English speakers
- Individuals who are unwilling or unable to provide informed consent or comply with study procedures
- Current active illness (e.g., cold, flu, bronchitis, suspected COVID-19)
- Have known allergies or previous reaction to titanium or medical-grade plastic
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- Report regularly sleeping <4 hours per night
- Restricted peripheral circulation (e.g. Raynaud's disease)
- Individuals with physical limitations or deformities or skin conditions that would preclude safely wearing up to two Oura Ring devices or reference polysomnography equipment
- Individuals that have completed overnight rotating shift-work in the past 2 weeks
- Individuals that have traveled across time-zones in the past week
- Current use (within the past month) of the following medications/classes, pending investigator decision: Stimulants (Adderall, Ritalin); Sodium oxybate; Heroin, cocaine, or methamphetamines; Non-stimulant wake promoting agents (e.g. modafinil, pitolisant, etc.); Prescription sleep medication
- Individuals employed by a company that develops or sells medical and/or fitness devices in a similar space (e.g. wearables) or are technology journalists (e.g. professional bloggers, TV, magazine, newspaper reporters, etc.)
- Sleep Apnea sample Inclusion Criteria
- High risk for mild-to-severe sleep apnea, defined by at least one of the following:
- Prior clinical diagnosis of obstructive sleep apnea (OSA)
- Currently seeking or actively undergoing treatment for sleep apnea (e.g., PAP therapy, oral appliance)
- Documented apnea-hypopnea index (AHI) ≥5 events/hour from a previous sleep study
- Self-reported Habitual sleep duration of 6-9 hours
- Willing and able to comply with study requirements Exclusion criteria
- Same as for Healthy Adult sample, with the exception of the "high risk for mild-to-moderate sleep apnea) criterion
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Clayton Sleep Institute Sleep Center
St Louis, Missouri, 63123
Matthew Uhles, MS, RPSGT, RST, 314-645-5855 ext. 318, uhlesm@claytonsleep.com
About this study
Official title: Oura Ring OA15 Overnight Features Validation
The current study intends to collect data from Oura Ring time-locked to ground truth medical sleep diagnostic gold-standard polysomnography (PSG) for product research and development, investigational algorithm validation, and scientific dissemination.
- Conditions
- Healthy Adult, Sleep Apnea
- Medical subject headings
- Sleep Apnea Syndromes
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Healthy Adult | Healthy adults with no known sleep disorders | |
| Adults with Sleep Apnea | High risk for mild-to-severe sleep apnea, defined by at least one of the following: 1. Prior clinical diagnosis of obstructive sleep apnea (OSA) 2. Currently seeking or actively undergoing treatment for sleep apnea (e.g., PAP therapy, oral appliance) 3. Documented apnea-hypopnea index (AHI) ≥5 events/hour from a previous sleep study |
What is being measured
The primary outcome is the main question the study is designed to answer.
Sleep staging performance (co-primary endpoint)
Agreement between Oura Ring sleep stage output and adjudicated PSG sleep stage scoring across the overnight in-laboratory recording (quantified by overall accuracy, Cohen's kappa, and class-specific sensitivity, specificity, positive predictive value, and F1 score for Wake, REM, and NREM sleep).
Measured: Single time-point assessment post-overnight-PSG visit (baseline).
Signal quality performance (co-primary endpoint)
Signal-to-noise ratio for overnight SpO2 signal quality.
Measured: Single time-point assessment post-overnight-PSG visit (baseline).
Secondary outcomes (7)
Respiratory event detection performance - apnea events
Event-level detection of PSG-scored apnea events by Oura Ring, quantified by sensitivity, positive predictive value, false positive rate per hour, and F1 score.
Measured: Single time-point assessment post-overnight-PSG visit (baseline).
Respiratory event detection performance - hypopnea events
Event-level detection of PSG-scored hypopnea events by Oura Ring, quantified by sensitivity, positive predictive value, false positive rate per hour, and F1 score.
Measured: Single time-point assessment post-overnight-PSG visit (baseline).
Respiratory event detection performance - oxygen desaturation events
Event-level detection of PSG-scored oxygen desaturation events by Oura Ring, quantified by sensitivity, positive predictive value, false positive rate per hour, and F1 score.
Measured: Single time-point assessment post-overnight-PSG visit (baseline).
Overnight SpO2 agreement
Agreement between Oura Ring overnight oxygen saturation estimates and PSG reference SpO2 measurements over matched overnight intervals, which may be quantified by mean bias, mean absolute error, root mean squared error, correlation, and Bland-Altman limits of agreement.
Measured: Single time-point assessment post-overnight-PSG visit (baseline).
Overnight heart rate and HRV agreement
Agreement between Oura Ring overnight heart rate and heart rate variability estimates and ECG-derived reference metrics over matched overnight intervals, which may be quantified by mean bias, mean absolute error, root mean squared error, correlation, and Bland-Altman limits of agreement.
Measured: Single time-point assessment post-overnight-PSG visit (baseline).
Data completion (proportion of overnight recording time)
Proportion of intended overnight recording time yielding valid Oura outputs (across sleep staging, heart rate, heart rate variability, SpO2, and Sleep Apnea Risk).
Measured: Single time-point assessment post-overnight-PSG visit (baseline).
Data completion (proportion of participants with complete datasets)
Proportion of participants contributing analyzable data for all Oura outputs (sleep staging, heart rate, heart rate variability, SpO2, and sleep apnea risk).
Measured: Single time-point assessment post-overnight-PSG visit (baseline).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Nov 2026
- Study start28 Aug 2026
- Primary completion3 Dec 2026 (estimated)
- Study completion31 Jan 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Healthy AdultStudies 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
- Observational
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ouraring Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Clayton Sleep Institute, LLC
- Responsible party
- Sponsor
- Investigators
- Joseph Ojile, MD, Principal investigator, Clayton Sleep Institute, LLC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07908199
- Sponsor's protocol ID
- OS26HW01
- Status last verified
- Oct 2026
- First submitted
- 5 Oct 2026
- Last updated
- 2 Nov 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: IPD will not be shared as part of this study.
Study at a glance
From the registry record, last updated by the sponsor on 2 Nov 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Oura Ring OA15 Overnight Features Validation
- ClinicalTrials.gov ID
- NCT07908199
- Acronym / sponsor ID
- OS26HW01
- Conditions
- Healthy Adult, Sleep Apnea
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Ouraring Inc.Industry (pharma, biotech, devices)
- Collaborators
- Clayton Sleep Institute, LLC
- Study start
- 28 Aug 2026 (actual)
- Primary completion
- 3 Dec 2026 (estimated)
- Study completion
- 31 Jan 2027 (estimated)
- First posted
- 2 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.
The current study intends to collect data from Oura Ring time-locked to ground truth medical sleep diagnostic gold-standard polysomnography (PSG) for product research and development, investigational algorithm validation, and scientific dissemination.
Study design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Healthy Adult | – | –Healthy adults with no known sleep disorders |
| Adults with Sleep Apnea | – | –High risk for mild-to-severe sleep apnea, defined by at least one of the following: 1. Prior clinical diagnosis of obstructive sleep apnea (OSA) 2. Currently seeking or actively undergoing treatment for sleep apnea (e.g., PAP therapy, oral appliance) 3. Documented apnea-hypopnea index (AHI) ≥5 events/hour from a previous sleep study |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- The study population will be composed of adults in the general population in the St. Louis area, including patients from the clinic database and general community.
Key inclusion criteria (4 listed)
- Ages 18-85 y
- Body mass index (BMI) <30 kg/m2
- Self-reported habitual sleep duration of 6-9 hours
- Willing and able to comply with the study requirements
Key exclusion criteria (21 listed)
- High risk for mild-to-severe sleep apnea
- Individuals with pacemakers
- Non-English speakers
- Individuals who are unwilling or unable to provide informed consent or comply with study procedures
- Current active illness (e.g., cold, flu, bronchitis, suspected COVID-19)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Sleep staging performance (co-primary endpoint)
Time frame: Single time-point assessment post-overnight-PSG visit (baseline).
Agreement between Oura Ring sleep stage output and adjudicated PSG sleep stage scoring across the overnight in-laboratory recording (quantified by overall accuracy, Cohen's kappa, and class-specific sensitivity, specificity, positive predictive value, and F1 score for Wake, REM, and NREM sleep).
Signal quality performance (co-primary endpoint)
Time frame: Single time-point assessment post-overnight-PSG visit (baseline).
Signal-to-noise ratio for overnight SpO2 signal quality.
7 secondary outcomes
Respiratory event detection performance - apnea events
Time frame: Single time-point assessment post-overnight-PSG visit (baseline).
Respiratory event detection performance - hypopnea events
Time frame: Single time-point assessment post-overnight-PSG visit (baseline).
Respiratory event detection performance - oxygen desaturation events
Time frame: Single time-point assessment post-overnight-PSG visit (baseline).
Overnight SpO2 agreement
Time frame: Single time-point assessment post-overnight-PSG visit (baseline).
Overnight heart rate and HRV agreement
Time frame: Single time-point assessment post-overnight-PSG visit (baseline).
Data completion (proportion of overnight recording time)
Time frame: Single time-point assessment post-overnight-PSG visit (baseline).
Data completion (proportion of participants with complete datasets)
Time frame: Single time-point assessment post-overnight-PSG visit (baseline).
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 2 Nov 2026.
- Individual participant dataSharing planned: No. IPD will not be shared as part of this study.
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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.
Joseph Ojile, MD principal investigator
Clayton Sleep Institute, LLC
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Healthy Adult and Sleep Apnea, run by Ouraring Inc. 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 4 inclusion and 21 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: looking for participants now, as of the sponsor's last update on 2 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 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?
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 Emma H Beisheim-Ryan, PT, DPT, PhD (585-975-9644, emma.beisheim-ryan@ouraring.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Sleep staging performance (co-primary endpoint) (time frame: Single time-point assessment post-overnight-PSG visit (baseline).). The study lists 2 primary outcomes in all. 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 2 Nov 2026.