ClinicalTrials.gg
RecruitingNCT07908199Updated Nov 2, 2026

Oura Ring OA15 Validation

An observational study in Healthy Adult and Sleep Apnea, sponsored by Ouraring Inc.. Recruiting at 1 site in United States. Open to participants aged 18 Years to 85 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-11-02.

Sponsored by Ouraring Inc. · Observational

From the registry’s dates

  • Started Aug 2026; still recruiting 2 months later.
Updated Nov 2, 2026Newly registeredGo to Updates ↓
Study type
Observational
Model
Case-control
Time perspective
Cross-sectional
Enrollment
60
Ages
18 Years to 85 Years
Sex
All
01

Where this study stands

Counted across the records on this site · 2026-11-12

Among 369 studies in Sleep Apnea Syndromes with a site in United States — 49 open to participants now, 60 under way, 3 of them phase 3. Sleep Apnea Syndromes · United States.

Planned enrollment
53rd of 82
60 · median 114
Started
2026
with 14 others
Observational
82 of 369
9 open now
Primary completion
2026-12
later than 10 of 59 live
Registered
366th of 369
by date

Among the 369 studies in Sleep Apnea Syndromes with a site in United States, this one is the 53rd largest by planned enrollment of the 82 observational ones, is one of 15 that started in 2026, is one of 82 observational ones, reaches primary completion later than 10 of the 59 other live ones, and was the 366th registered.

By phase

369 studies; the count open now beside each. This study's row is marked.

No phase193 · 22 open
Observationalthis study82 · 9 open
Phase 228 · 3 open
Phase 420 · 7 open
Phase 115 · 2 open
Phase 315 · 3 open
Phase 1/210 · 3 open
Phase 2/36 · 0 open

By the year they started

First in 1998; this study’s year is marked. 15 started in 2026.

Size and results

Median enrollment 62 across the 284 interventional studies, 114 across the 82 observational. Of the 268 that completed or were terminated, 134 (50%) have results posted.

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Watch this landscapeDownload CSVWith an account: a weekly mail of what changed among 369 studies in Sleep Apnea Syndromes with a site in United States, or all of them as a file.
02

Study 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.

03

Conditions studied

  • Healthy Adult
  • Sleep Apnea
04

Who can participate

Ages eligible
18 Years to 85 Years
Sexes eligible
All
Accepts healthy volunteers
Yes
Sampling method
Non-probability sample

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.

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Healthy sample

Inclusion criteria

Inclusion Criteria:

  • Ages 18-85 y
  • (BMI) \<30 kg/m2
  • Self-reported habitual sleep duration of 6-9 hours
  • Willing and able to comply with the study requirements

Exclusion criteria

Exclusion Criteria:

  • High risk for mild-to-severe sleep apnea
  • Individuals with pacemakers
  • Non-English speakers
  • Individuals who are unwilling or unable to provide 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
  • 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
Terms in these criteria, in plain language(2)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

BMI (body mass index)

Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.

What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

05

Study design

Observational model
Case-control
Time perspective
Cross-sectional
Enrollment
60 participants (estimated)
Patient registry
No

Groups and cohorts

  • 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

06

What researchers measure

Primary outcomes

  1. 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).

    Time frame: Single time-point assessment post-overnight-PSG visit (baseline).

  2. Signal quality performance (co-primary endpoint)

    Signal-to-noise ratio for overnight SpO2 signal quality.

    Time frame: Single time-point assessment post-overnight-PSG visit (baseline).

Secondary outcomes

  1. 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.

    Time frame: Single time-point assessment post-overnight-PSG visit (baseline).

  2. 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.

    Time frame: Single time-point assessment post-overnight-PSG visit (baseline).

  3. 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.

    Time frame: Single time-point assessment post-overnight-PSG visit (baseline).

  4. 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.

    Time frame: Single time-point assessment post-overnight-PSG visit (baseline).

  5. 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.

    Time frame: Single time-point assessment post-overnight-PSG visit (baseline).

  6. 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).

    Time frame: Single time-point assessment post-overnight-PSG visit (baseline).

  7. 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).

    Time frame: Single time-point assessment post-overnight-PSG visit (baseline).

07

Study locations

1 of 1 sites recruiting
  • Clayton Sleep Institute Sleep Center
    St Louis, Missouri 63123, United States
    Recruiting
08

References and documents

Individual participant data

Plan to share: No — IPD will not be shared as part of this study.

No publications or documents are linked to this record.

09

Timeline

1 registry update since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reached

Started Aug 2026 (actual). Primary completion is estimated for Dec 2026, 3 months after the start.

How these figures are worked out, and which studies are left out of them.

Registered
Oct 5, 2026
First posted
Nov 2, 2026
StartActual
Aug 28, 2026
Primary completionEst.
Dec 3, 2026
CompletionEst.
Jan 31, 2027
Last update
Nov 2, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
Registered
First appeared on the registry. No changes since
Nov 2, 2026
Show all 1 update
  1. Nov 2, 2026
    First appeared on the registry

From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗

10

Registry details

Key details

Study ID
NCT07908199
Lead sponsor
Ouraring Inc.
Collaborators
Clayton Sleep Institute, LLC
Responsible party
Sponsor
First posted
Nov 2, 2026
Start date
Aug 28, 2026
Primary completion
Dec 3, 2026 (estimated)
Completion
Jan 31, 2027 (estimated)
Last update
Nov 2, 2026

Study contacts

Emma H Beisheim-Ryan, PT, DPT, PhD
Contact
emma.beisheim-ryan@ouraring.com
585-975-9644
Joseph Ojile, MD
principal investigator · Clayton Sleep Institute, LLC

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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