SleepNCT05276362
Study Watch Sleep Metric Performance Characterization Study
An observational study of Sleep and Obstructive Sleep Apnea, run by Verily Life Sciences LLC at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Sleep, Obstructive Sleep Apnea, Insomnia
- What is being tested?
- Study Watch and Actiwatch
- Type of treatment
- Medical device
- How many people
- 90 participants
- Where
- 1 siteUnited States
- Study dates
- 4 Mar 2022to 20 Sep 2023
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
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.
Who may be able to join
- 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)
Show all 44Show fewer
- 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.
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
About this 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.
- Conditions
- Sleep, Obstructive Sleep Apnea, Insomnia
- Being tested
- Study Watch, Actiwatch
- Medical subject headings
- Sleep Apnea, Obstructive, Sleep Initiation and Maintenance Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Study WatchDevice
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.
ActiwatchDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: 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. Receives: Device: Study Watch; Device: Actiwatch |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 1 night
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Mar 2022
- Study start4 Mar 2022
- Primary completion20 Sep 2023
- Study completion20 Sep 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for SleepStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 90 participants (actual)
Sponsor and investigators
- Lead sponsor
- Verily Life Sciences LLC
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Benjamin Nelson, PhD, Study director, Verily Life Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05276362
- Sponsor's protocol ID
- 103845
- Status last verified
- May 2024
- First submitted
- 25 Feb 2022
- Last updated
- 2 May 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
Publications
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.
PubMed 41424491
Study at a glance
From the registry record, last updated by the sponsor on 2 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study Watch Sleep Metric Performance Characterization Study
- ClinicalTrials.gov ID
- NCT05276362
- Acronym / sponsor ID
- 103845
- Conditions
- Sleep, Obstructive Sleep Apnea, Insomnia
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 90 participants (actual)
- Lead sponsor
- Verily Life Sciences LLCIndustry (pharma, biotech, devices)
- Study start
- 4 Mar 2022 (actual)
- Primary completion
- 20 Sep 2023 (actual)
- Study completion
- 20 Sep 2023 (actual)
- First posted
- 11 Mar 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Typical Sleepers | – | Device: Study Watch, Device: ActiwatchThis 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. |
| Sleepers with Elevated Insomnia Symptoms | – | Device: Study Watch, Device: ActiwatchThis 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. |
| Sleepers withObstructive Sleep Apnea Sleepers | – | Device: Study Watch, Device: ActiwatchThis 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. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (44 listed)
- 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:
- 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
Key exclusion criteria (0 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Study WatchThe 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 | Sleepers with Elevated Insomnia Symptoms, Sleepers withObstructive Sleep Apnea Sleepers, Typical Sleepers |
| ActiwatchThe 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. | Device | Sleepers with Elevated Insomnia Symptoms, Sleepers withObstructive Sleep Apnea Sleepers, Typical Sleepers |
Primary outcome
Accuracy of sleep/wake detection - Sensitivity and Specificity
Time frame: 1 night
Accuracy of sleep/wake detection will be reported on 30 second epochs from lights off to lights on in typical sleepers.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 May 2024.
- Derived from this study: PubMed 41424491Saeb 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Benjamin Nelson, PhD study director
Verily Life Sciences
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Sleep and Obstructive Sleep Apnea, run by Verily Life Sciences LLC at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 44 inclusion and 0 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 2 May 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Accuracy of sleep/wake detection - Sensitivity and Specificity (time frame: 1 night). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05276362, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 May 2024; AzTrials last refreshed its copy on 27 Oct 2026.