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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.
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Inclusion and exclusion criteria
Inclusion Criteria:
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:
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
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
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
Medical
Psychiatric
Participant uses supplemental oxygen during the day or night
Participant is unwilling to cease use of CPAP or oral appliance for sleep-disordered breathing during the In-Lab Overnight Visit; or cessation is deemed to be of substantial risk in the opinion of the Principal Investigator
Women who are pregnant, lactating, or breastfeeding
Participant takes prescription stimulants, sedatives, opioids, alpha blockers, short acting nitrates, or any other medication that, in the opinion of the Principal Investigator and study team, impacts their sleep behavior
Use of any sleep medications (over-the-counter or prescription) in the previous 24 hours for Typical Sleepers
Participant has a cardiac pacemaker, implantable defibrillator, medical pump, or other implantable medical electronic device
Participant has Shift Work Sleep Disorder (SWSD) or is a night-shift worker
Participant has traveled >3 time zone within two weeks prior to study
Participant is not fluent at reading and speaking English
Participant is deemed not to be a candidate for the study, in the opinion of the Principal Investigator
Known severe allergy to nickel or metal jewelry
Open injury or rash where the study device or comparator will be worn
Known severe allergy to polyester, nylon, or spandex material
Enrolled participants who meet exclusion criteria after PSG, upon confirmation with the principal investigator and study team, will be discontinued and excluded from primary analyses.
90 participants in 3 patient groups
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Central trial contact
Juliana Moreno-Ramirez; Salvatore Campo
Data sourced from clinicaltrials.gov
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