Back to resultsClinical Validation of New Commercial Sleep Monitoring Devices
Primary Purpose
Sleep Apnea
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Fitbit
Jawbone UP
Microsoft Band
Sponsored by
About this trial
This is an interventional diagnostic trial for Sleep Apnea focused on measuring In lab sleep studies
Eligibility Criteria
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.
Sites / Locations
- Weill Cornell Medicine Center for Sleep Medicine
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Active Comparator
Active Comparator
Active Comparator
Arm Label
Fitbit
Jawbone UP
Microsoft Band
Arm Description
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.
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.
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.
Outcomes
Primary Outcome Measures
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).
Secondary Outcome Measures
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).
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)
Sleep Efficiency as Measured by Fitbit Charge2 or Microsoft Band2.
Statistical analysis will examine agreement levels of sleep metrics such as Sleep Efficiency (SE)
Full Information
NCT ID
NCT02779543
First Posted
May 17, 2016
Last Updated
March 13, 2019
Sponsor
Weill Medical College of Cornell University
Collaborators
Cornell University
1. Study Identification
Unique Protocol Identification Number
NCT02779543
Brief Title
Clinical Validation of New Commercial Sleep Monitoring Devices
Official Title
Clinical Validation of New Commercial Sleep Monitoring Devices
Study Type
Interventional
2. Study Status
Record Verification Date
March 2019
Overall Recruitment Status
Completed
Study Start Date
June 1, 2018 (Actual)
Primary Completion Date
July 30, 2018 (Actual)
Study Completion Date
July 30, 2018 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Weill Medical College of Cornell University
Collaborators
Cornell University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Sleep Apnea
Keywords
In lab sleep studies
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
200 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Fitbit
Arm Type
Active Comparator
Arm Description
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.
Arm Title
Jawbone UP
Arm Type
Active Comparator
Arm Description
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.
Arm Title
Microsoft Band
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Device
Intervention Name(s)
Fitbit
Intervention Description
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.
Intervention Type
Device
Intervention Name(s)
Jawbone UP
Intervention Description
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.
Intervention Type
Device
Intervention Name(s)
Microsoft Band
Intervention Description
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.
Primary Outcome Measure Information:
Title
Total Sleep Time as Measured by Fitbit Charge2 or Microsoft Band2.
Description
Statistical analysis will examine agreement levels of sleep metrics such as Total Sleep Time (TST).
Time Frame
1 night, approximately 9 hours.
Secondary Outcome Measure Information:
Title
Sleep Onset Latency as Measured by Fitbit Charge2 or Microsoft Band2.
Description
Statistical analysis will examine agreement levels of sleep metrics such as Sleep Onset Latency (SOL).
Time Frame
1 night, approximately 9 hours.
Title
Wake Time After Sleep Onset as Measured by Fitbit Charge2 or Microsoft Band2.
Description
Statistical analysis will examine agreement levels of sleep metrics such as Wake After Sleep Onset (WASO)
Time Frame
1 night, approximately 9 hours.
Title
Sleep Efficiency as Measured by Fitbit Charge2 or Microsoft Band2.
Description
Statistical analysis will examine agreement levels of sleep metrics such as Sleep Efficiency (SE)
Time Frame
1 night, approximately 9 hours.
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ana Krieger, M.D., M.P.H
Organizational Affiliation
Weill Medical College of Cornell University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Weill Cornell Medicine Center for Sleep Medicine
City
New York
State/Province
New York
ZIP/Postal Code
10065
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Clinical Validation of New Commercial Sleep Monitoring Devices
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