Study Watch Sleep Metric Performance Characterization Study

NCT05276362 | Completed FDA Device

• 1 other identifier: 103845
• Study Type: observational
• Target: 90
• Locations: 1 country
• Sites: 1

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 as compared to polysomnography.

Conditions

Sleep; Obstructive Sleep Apnea; Insomnia

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (3)

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; Device: Actiwatch

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; Device: Actiwatch

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; Device: Actiwatch

Interventions

Study Watch DEVICE

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.

Sleepers with Elevated Insomnia Symptoms; Sleepers withObstructive Sleep Apnea Sleepers; Typical Sleepers

Actiwatch DEVICE

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; Sleepers withObstructive Sleep Apnea Sleepers; Typical Sleepers

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

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

You may not qualify if:

• 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 \[ALS\])

Sponsors & Collaborators

• Verily Life Sciences LLC: lead

Study Sites (1)

SRI International

Menlo Park, California, 94025, United States

Location

Related Publications (1)

• Saeb S, Nelson BW, Barman P, Verma N, Allen H, de Zambotti M, Baker FC, Arra N, Sridhar N, Sullivan SS, Plowman S, Rainaldi E, Kapur R, Shin S. Performance of the Verily Study Watch for measuring sleep compared to polysomnography. Front Sleep. 2024 Dec 13;3:1481878. doi: 10.3389/frsle.2024.1481878. eCollection 2024.

  PMID: 41424491 DERIVED

MeSH Terms

Conditions

Sleep Apnea, Obstructive; Sleep Initiation and Maintenance Disorders

Condition Hierarchy (Ancestors)

Sleep Apnea Syndromes; Apnea; Respiration Disorders; Respiratory Tract Diseases; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Nervous System Diseases; Mental Disorders

Study Officials

• Benjamin Nelson, PhD

  Verily Life Sciences

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 25, 2022
• First Posted: March 11, 2022
• Study Start: March 4, 2022
• Primary Completion: September 20, 2023
• Study Completion: September 20, 2023
• Last Updated: May 2, 2024

Record last verified: 2024-05

Locations

US (1)