Study Watch Sleep Metric Performance Characterization Study

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.

Study Overview

• Status: Completed
• Conditions: Insomnia; Sleep; Obstructive Sleep Apnea
• Intervention / Treatment: Device: Study Watch; Device: Actiwatch

• Study Type: Observational
• Enrollment (Actual): 90

Contacts and Locations

Study Locations

• United States
  • California
    • Menlo Park, California, United States, 94025
      • SRI International

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

• Sampling Method: Non-Probability Sample

Study Population

Complete datasets will be collected on approximately 70 typical sleepers, at least 15 participants with Obstructive Sleep Apnea (OSA), and at least 15 participants with elevated insomnia symptoms.

Description

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:

  • 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)
    • 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.

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

3

Cohorts and Interventions

Group / Cohort	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.
Sleepers with Elevated Insomnia Symptoms; This will be a single arm study of at least 15 participants with elevated insomnia symptoms 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.
Sleepers withObstructive Sleep Apnea Sleepers; This will be a single arm study of at least 15 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Accuracy of sleep/wake detection - Sensitivity and Specificity	Accuracy of sleep/wake detection will be reported on 30 second epochs from lights off to lights on in typical sleepers.	1 night

Collaborators and Investigators

• Sponsor: Verily Life Sciences LLC
• Investigators: Study Director: Benjamin Nelson, PhD, Verily Life Sciences

Study record dates

Study Major Dates

• Study Start (Actual): March 4, 2022
• Primary Completion (Actual): September 20, 2023
• Study Completion (Actual): September 20, 2023

Study Registration Dates

• First Submitted: February 25, 2022
• First Submitted That Met QC Criteria: March 2, 2022
• First Posted (Actual): March 11, 2022

Study Record Updates

• Last Update Posted (Estimated): May 2, 2024
• Last Update Submitted That Met QC Criteria: May 1, 2024
• Last Verified: May 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Nervous System Diseases; Respiratory Tract Diseases; Apnea; Respiration Disorders; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Sleep Apnea Syndromes; Sleep Apnea, Obstructive
• Other Study ID Numbers: 103845

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes