Study Watch Sleep Metric Performance Characterization Study
Completed
Conditions studied: Sleep, Obstructive Sleep Apnea, Insomnia
In brief
This is a multi-center, single-arm, prospective performance evaluation study designed to assess performance of sleep metrics calculated from sensor data that is collected from two versions of the Verily Study Watch as compared to polysomnography.
Key facts
- Study ID
- NCT05276362
- Run by
- Verily Life Sciences LLC
- People needed
- 90
- Starts
- 2022-03-04
- Expected to finish
- 2023-09-20
- Last updated by the study team
- 2024-05-02
Who can join
Age: 18 and older, up to 80. Sex: any. Healthy volunteers: accepted.
You may qualify if…
- Participant is ≥ 18 and ≤ 80 years old
- Participant understands the study requirements and is able and willing to provide written informed consent
- Participant is without significant limitation in ability to participate in the study, in the opinion of the investigator
- Participant belongs to one of the following participant groups as determined by screening questionnaires:
- Typical sleepers (i.e., STOP-Bang score of 0-2 or OSA50 < 5, Insomnia Severity Index (ISI) < 8, and Epworth Sleepiness Scale (ESS) < 10), and no evidences of sleep-disordered breathing at the PSG evaluation
- Insomnia sleepers (i.e., ISI > 10 and PSG AHI < 5)
- Sleep apnea sleepers (i.e., STOP-Bang score of 3-8 or OSA50 ≥ 5) or moderate to severe obstructive sleep apnea (PSG AHI ≥5))
- Participant has agreed to abstain from caffeine, nicotine, alcohol, and cannabis products for 8 hours prior to the In-Lab Screening Visit and until the visit is completed
- Exception - unless the participant use of product has approval from the Principal Investigator
- Participant has agreed to abstain from OTC or PRN medications that are not regularly used on a daily basis and may affect sleep/wakefulness for 24 hours prior to the In-Lab Overnight Visit and during the study visit
- Exception - unless the participant uses OTC or PRN medication on a routine basis and has approval from the Principal Investigator
- Exclusion Criteria: Conditions based on self-report of having been told by a doctor of a formal diagnosis
- Presence of any of the following diagnosed sleep, medical, or psychiatric disorders:
- Sleep
- Narcolepsy
- Restless leg syndrome
- Circadian rhythm sleep disorder
- Periodic Limb Movement Disorder
- REM Sleep behavior disorder
- Medical
- Epilepsy or other seizure disorder
- Renal failure or chronic kidney disease
- Acute or chronic infection that may interfere with the study
- Movement neurological disorder that impairs movement or autonomic stability (e.g. Parkinson's disease, Huntington's disease)
- Cardiopulmonary diseases (e.g. heart failure, chronic obstructive pulmonary disease, ventilatory disorders)
Where it is running
- SRI International — Menlo Park, California, United States
Full record on ClinicalTrials.gov
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