Status:
COMPLETED
Study Watch Sleep Metric Performance Characterization Study
Lead Sponsor:
Verily Life Sciences LLC
Conditions:
Sleep
Obstructive Sleep Apnea
Eligibility:
All Genders
18-80 years
Brief Summary
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 Veri...
Eligibility Criteria
Inclusion
- 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
- 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)
- Persistent arrhythmias and dysrhythmias
- Severe neuromuscular disease (e.g. Amyotrophic lateral sclerosis \[ALS\])
- Psychiatric
- Severe significant mood disorder (e.g. depression, bipolar disorder)
- Substance use disorder
- 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.
Key Trial Info
Start Date :
March 4 2022
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
September 20 2023
Estimated Enrollment :
90 Patients enrolled
Trial Details
Trial ID
NCT05276362
Start Date
March 4 2022
End Date
September 20 2023
Last Update
May 2 2024
Active Locations (1)
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1
SRI International
Menlo Park, California, United States, 94025