Ireland
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Recruiting Observational

Oura Ring OA15 Validation

NCT07908199 · tracked via the Priya Life Science USA tracker
Sponsor
Ouraring Inc
Phase
Observational
Started
2026-08-28
Last updated
2026-11-02

Condition(s) studied

Healthy AdultSleep Apnea

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.

Eligibility

Sex
ALL
Min age
18 Years
Max age
85 Years
Healthy volunteers
Accepted
Healthy sample Inclusion Criteria: * 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 Exclusion Criteria: * 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 * 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

Primary outcome measure(s)

  • Sleep staging performance (co-primary endpoint) — 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) — Single time-point assessment post-overnight-PSG visit (baseline).
    Signal-to-noise ratio for overnight SpO2 signal quality.

Trial sites (1)

FacilityCityRegionStatus
Clayton Sleep Institute Sleep Center St Louis Missouri Recruiting
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07908199 on ClinicalTrials.gov ↗ ← All trials in the USA