Study Watch Sleep Metric Performance Study
Study Details
Study Description
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 Verily Study Watch.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
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Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Typical Sleepers This will be a single arm study of approximately 70 typical sleepers that will wear the Study Watch(es) and Actiwatch for one night in a sleep laboratory. |
Device: Study Watch
The Study Watch is an investigational wrist worn wearable device made with biocompatible contact materials containing various sensors capable of continuous recording of physiological, activity, and environmental data.
Device: Actiwatch
The Actiwatch is a wrist worn activity device designed to collect general activity and sleep information. This device received 510(k) clearance from the FDA as a wearable medical data collection device for research and clinical use.
|
| Insomnia Sleepers This will be a single arm study of at least 25 participants with insomnia that will wear the Study Watch(es) and Actiwatch for one night in a sleep laboratory. |
Device: Study Watch
The Study Watch is an investigational wrist worn wearable device made with biocompatible contact materials containing various sensors capable of continuous recording of physiological, activity, and environmental data.
Device: Actiwatch
The Actiwatch is a wrist worn activity device designed to collect general activity and sleep information. This device received 510(k) clearance from the FDA as a wearable medical data collection device for research and clinical use.
|
| Obstructive Sleep Apnea Sleepers This will be a single arm study of at least 25 participants with obstructive sleep apnea that will wear the Study Watch(es) and Actiwatch for one night in a sleep laboratory. |
Device: Study Watch
The Study Watch is an investigational wrist worn wearable device made with biocompatible contact materials containing various sensors capable of continuous recording of physiological, activity, and environmental data.
Device: Actiwatch
The Actiwatch is a wrist worn activity device designed to collect general activity and sleep information. This device received 510(k) clearance from the FDA as a wearable medical data collection device for research and clinical use.
|
Outcome Measures
Primary Outcome Measures
- Accuracy of sleep/wake detection - Sensitivity and Specificity [1 night]
Accuracy of sleep/wake detection will be reported on 30 second epochs from lights off to lights on in typical sleepers.
Eligibility Criteria
Criteria
Inclusion Criteria:
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Between the ages of 18 and 80 years old
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Understands the study requirements and is able and willing to provide written informed consent
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Without significant limitation in ability to participate in the study, in the opinion of the investigator
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Belongs to one of the following participant groups: Typical sleepers, Insomnia sleepers, and Sleep apnea sleepers
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Able to abstain from alcohol, marijuana, and cannabinoid products for 24 hours prior to the In-Lab Screening Visit and agrees to abstain during the In-Lab Overnight Visit
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Able to abstain from OTC medications that may affect sleep/wakefulness for 24 hours prior to the In-Lab Screening Visit and agrees to abstain during the In-Lab Overnight Visit
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Able to abstain from nicotine within the 4 hours prior to the scheduled In-Lab Screening Visit and agrees to abstain during the In-Lab Overnight Visit
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Able to abstain from caffeine within the 8 hours prior to the scheduled In-Lab Screening Visit and agrees to abstain during the In-Lab Overnight Visit
Exclusion Criteria: Conditions based on self-report of having been told by a doctor of a formal diagnosis
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Participant has narcolepsy
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Participant has severe significant mood disorder (e.g. depression, bipolar disorder)
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Participant uses nighttime oxygen
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Participant has epilepsy or other seizure disorder
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Participant has renal failure or chronic kidney disease
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Participant has acute or chronic infection that may interfere with the study
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Participant has Shift Work Sleep Disorder (SWSD) or is a night-shift worker
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Participant has movement disorder (e.g. Parkinson's disease, Huntington's disease)
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Participant has cardiopulmonary diseases (e.g. heart failure, chronic obstructive pulmonary disease, ventilatory disorders)
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Participant has severe neuromuscular disease (e.g. Amyotrophic lateral sclerosis [ALS])
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Participant has substance use disorder
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Participant has REM behavior disorder
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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
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Pregnant (for women)
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Routinely or daily takes prescription stimulants or opioids.
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Has a cardiac pacemaker, implantable defibrillator, medical pump, or other implantable medical electronic device
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Not fluent at reading and speaking English
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Deemed not to be a candidate for the study, in the opinion of the Principal Investigator
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Known severe allergy to nickel or metal jewelry
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Open injury or rash where the study device or comparator will be worn
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Known severe allergy to polyester, nylon, or spandex material
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | SRI International | Menlo Park | California | United States | 94025 |
Sponsors and Collaborators
- Verily Life Sciences LLC
Investigators
- Study Director: Shannon Sullivan, MD, Verily Life Sciences
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- 103845