Study Watch Sleep Metric Performance Characterization Study

Last updated: May 1, 2024
Sponsor: Verily Life Sciences LLC
Overall Status: Completed

Phase

N/A

Condition

Insomnia

Sleep Apnea Syndromes

Treatment

Actiwatch

Study Watch

Clinical Study ID

NCT05276362
103845
  • Ages 18-80
  • All Genders
  • Accepts Healthy Volunteers

Study 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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Participant is ≥ 18 and ≤ 80 years old
  • Participant understands the study requirements and is able and willing to providewritten 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 byscreening questionnaires:
  • Typical sleepers (i.e., STOP-Bang score of 0-2 or OSA50 < 5, Insomnia SeverityIndex (ISI) < 8, and Epworth Sleepiness Scale (ESS) < 10), and no evidences ofsleep-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 tosevere obstructive sleep apnea (PSG AHI ≥5))
  • Participant has agreed to abstain from caffeine, nicotine, alcohol, and cannabisproducts for 8 hours prior to the In-Lab Screening Visit and until the visit iscompleted
  • Exception - unless the participant use of product has approval from the PrincipalInvestigator
  • Participant has agreed to abstain from OTC or PRN medications that are not regularlyused on a daily basis and may affect sleep/wakefulness for 24 hours prior to theIn-Lab Overnight Visit and during the study visit
  • Exception - unless the participant uses OTC or PRN medication on a routine basisand has approval from the Principal Investigator

Exclusion

Exclusion Criteria: Conditions based on self-report of having been told by a doctor of aformal 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 pulmonarydisease, 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-disorderedbreathing during the In-Lab Overnight Visit; or cessation is deemed to be ofsubstantial risk in the opinion of the Principal Investigator
  • Women who are pregnant, lactating, or breastfeeding
  • Participant takes prescription stimulants, sedatives, opioids, alpha blockers, shortacting nitrates, or any other medication that, in the opinion of the PrincipalInvestigator and study team, impacts their sleep behavior
  • Use of any sleep medications (over-the-counter or prescription) in the previous 24hours for Typical Sleepers
  • Participant has a cardiac pacemaker, implantable defibrillator, medical pump, or otherimplantable 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 thePrincipal 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 withthe principal investigator and study team, will be discontinued and excluded fromprimary analyses.

Study Design

Total Participants: 90
Treatment Group(s): 2
Primary Treatment: Actiwatch
Phase:
Study Start date:
March 04, 2022
Estimated Completion Date:
September 20, 2023

Connect with a study center

  • SRI International

    Menlo Park, California 94025
    United States

    Site Not Available

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