Clinical Validation of New Commercial Sleep Monitoring Devices

Not Applicable

Completed

• Conditions: Sleep Apnea
• Interventions: Device: Jawbone UP; Device: Microsoft Band; Device: Fitbit

• Registration Number: NCT02779543
• Lead Sponsor: Weill Medical College of Cornell University

Brief Summary

This study seeks to validate three new commercial sleep monitoring devices: Fitbit, Jawbone UP, and Microsoft Band by comparison against concurrent polysomnography (PSG), which is considered the gold standard for sleep assessment. This research is being done because if proven to accurately analyze sleep,these devices may make conducting in-home sleep studies easier and more affordable in the future.

Detailed Description

This study seeks to validate three new commercial sleep monitoring devices: Fitbit, Jawbone UP, and Microsoft Band by comparison against concurrent polysomnography (PSG), considered the gold standard assessment for sleep physiology. The investigators emphasize here that the commercial sleep monitoring devices (Fitbit, Jawbone UP, and Microsoft Band) are used in addition to PSG and not in place of it. Subjects will be recruited from those patients attending a regularly scheduled overnight PSG sleep study at the Weill Cornell Medical College Center for Sleep Medicine. Willing subjects, after providing informed consent, will be fitted with one of the three aforementioned sleep monitoring devices (randomly assigned) on the wrist of their non-dominant hand when prepared for the sleep study by a technician. Subjects willing to wear more than one sleep monitoring device may be fitted with two different sleep monitoring devices, e.g., a Fitbit and a Jawbone UP or a Fitbit and a Microsoft Band. Sleep monitoring device(s) will be removed from the subject's wrist in the morning at the conclusion of the sleep study. Data will be transferred from the sleep monitoring device(s) for later statistical analysis and comparison with scored polysomnogram. Device(s) will be cleaned (using antiseptic wipes), reset,recharged, and otherwise prepared for reuse.

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study First Submitted: 2016-05-17
• Study First Submitted QC: 2016-05-19
• Study First Posted: 2016-05-20
• Study Start: 2018-06-01
• Primary Completion: 2018-07-30
• Study Completion: 2018-07-30
• Results First Submitted: 2018-12-10
• Status Verified: 2019-03
• Results First Submitted QC: 2019-03-13
• Last Update Submitted: 2019-03-13
• Results First Posted: 2019-03-14
• Last Update Posted: 2019-03-14

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 200

Inclusion Criteria

• Attending a regularly scheduled overnight polysomnography (PSG) sleep study at the Weill Cornell Medical College Center for Sleep Medicine.

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Exclusion Criteria

• Not attending a regularly scheduled overnight polysomnography (PSG) sleep study at the Weill Cornell Medical College Center for Sleep Medicine.
• Under 18 or over 80 years old.
• Pregnancy
• Unable to provide informed consent.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Jawbone UP	Jawbone UP	Subjects will be recruited from those patients attending a regularly scheduled overnight PSG sleep study at the Weill Cornell Medical College Center for Sleep Medicine. Willing subjects, after providing informed consent, will be fitted with one of the three aforementioned sleep monitoring devices (randomly assigned) on the wrist of their non dominant hand when prepared for the sleep study by a technician. Subjects willing to wear more than one sleep monitoring device may be fitted with two different sleep monitoring devices, e.g., a Fitbit and a Jawbone UP or a Fitbit and a Microsoft Band. Sleep monitoring device(s) will be removed from the subject's wrist in the morning at the conclusion of the sleep study.
Microsoft Band	Microsoft Band	Subjects will be recruited from those patients attending a regularly scheduled overnight PSG sleep study at the Weill Cornell Medical College Center for Sleep Medicine. Willing subjects, after providing informed consent, will be fitted with one of the three aforementioned sleep monitoring devices (randomly assigned) on the wrist of their non dominant hand when prepared for the sleep study by a technician. Subjects willing to wear more than one sleep monitoring device may be fitted with two different sleep monitoring devices, e.g., a Fitbit and a Jawbone UP or a Fitbit and a Microsoft Band. Sleep monitoring device(s) will be removed from the subject's wrist in the morning at the conclusion of the sleep study.
Fitbit	Fitbit	Subjects will be recruited from those patients attending a regularly scheduled overnight PSG sleep study at the Weill Cornell Medical College Center for Sleep Medicine. Willing subjects, after providing informed consent, will be fitted with one of the three aforementioned sleep monitoring devices (randomly assigned) on the wrist of their non dominant hand when prepared for the sleep study by a technician. Subjects willing to wear more than one sleep monitoring device may be fitted with two different sleep monitoring devices, e.g., a Fitbit and a Jawbone UP or a Fitbit and a Microsoft Band. Sleep monitoring device(s) will be removed from the subject's wrist in the morning at the conclusion of the sleep study.

Primary Outcome Measures

Name	Time	Method
Total Sleep Time as Measured by Fitbit Charge2 or Microsoft Band2.	1 night, approximately 9 hours.	Statistical analysis will examine agreement levels of sleep metrics such as Total Sleep Time (TST).

Secondary Outcome Measures

Name	Time	Method
Sleep Onset Latency as Measured by Fitbit Charge2 or Microsoft Band2.	1 night, approximately 9 hours.	Statistical analysis will examine agreement levels of sleep metrics such as Sleep Onset Latency (SOL).
Wake Time After Sleep Onset as Measured by Fitbit Charge2 or Microsoft Band2.	1 night, approximately 9 hours.	Statistical analysis will examine agreement levels of sleep metrics such as Wake After Sleep Onset (WASO)
Sleep Efficiency as Measured by Fitbit Charge2 or Microsoft Band2.	1 night, approximately 9 hours.	Statistical analysis will examine agreement levels of sleep metrics such as Sleep Efficiency (SE)

Trial Locations

Locations (1)

Weill Cornell Medicine Center for Sleep Medicine; 🇺🇸 New York, New York, United States