Clinical Validation of New Commercial Sleep Monitoring Devices

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.

Study Overview

• Status: Completed
• Conditions: Sleep Apnea
• Intervention / Treatment: Device: Fitbit; Device: Jawbone UP; Device: Microsoft Band

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.

• Study Type: Interventional
• Enrollment (Actual): 200
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • New York
    • New York, New York, United States, 10065
      • Weill Cornell Medicine Center for Sleep Medicine

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

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

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: Randomized
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: 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.	Device: 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.
Active Comparator: 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.	Device: 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.
Active Comparator: 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.	Device: 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.

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Weill Medical College of Cornell University
• Collaborators: Cornell University
• Investigators: Principal Investigator: Ana Krieger, M.D., M.P.H, Weill Medical College of Cornell University

Study record dates

Study Major Dates

• Study Start (Actual): June 1, 2018
• Primary Completion (Actual): July 30, 2018
• Study Completion (Actual): July 30, 2018

Study Registration Dates

• First Submitted: May 17, 2016
• First Submitted That Met QC Criteria: May 19, 2016
• First Posted (Estimate): May 20, 2016

Study Record Updates

• Last Update Posted (Actual): March 14, 2019
• Last Update Submitted That Met QC Criteria: March 13, 2019
• Last Verified: March 1, 2019

More Information

Terms related to this study

• Keywords: In lab sleep studies
• Additional Relevant MeSH Terms: Nervous System Diseases; Respiratory Tract Diseases; Apnea; Respiration Disorders; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Sleep Apnea Syndromes
• Other Study ID Numbers: 1509016542

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

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