Back to resultsMainstream Sleep Tracking Devices vs Polysomnography
Primary Purpose
Severe Sleep Apnea, Severe Insomnia, Epileptiform Activity
Status
Withdrawn
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Polysomnography Data
Jawbone UP®
Fitbit Charge ®
Sponsored by
About this trial
This is an interventional diagnostic trial for Severe Sleep Apnea
Eligibility Criteria
Inclusion Criteria:
- Patients undergoing Polysomnography
Exclusion Criteria:
- severe sleep apnea
- severe insomnia with less than two hours of sleep per night
- epileptiform activity
- electrical status epilepticus of sleep
Sites / Locations
- New York University School of Medicine
Arms of the Study
Arm 1
Arm Type
Other
Arm Label
Patients undergoing Polysomnography
Arm Description
Outcomes
Primary Outcome Measures
Time it takes subject to fall asleep
Number of Minutes of Sleep
Number of Arousals
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT02744235
Brief Title
Mainstream Sleep Tracking Devices vs Polysomnography
Official Title
Sensitivity and Specificity of Mainstream Sleep Tracking Devices Compared to Polysomnography
Study Type
Interventional
2. Study Status
Record Verification Date
April 2017
Overall Recruitment Status
Withdrawn
Why Stopped
Unable to move forward due to funding
Study Start Date
March 2016 (Actual)
Primary Completion Date
April 2017 (Actual)
Study Completion Date
April 2017 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
NYU Langone Health
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
The purpose of this study is to compare two popular portable sleep monitoring devices-the Fitbit Charge®, Jawbone UP®, and SleepTime smartphone app-to the "gold standard" Polysomnography (PSG). Parameters that will be analyzed include sleep onset latency, sleep efficiency, and sleep staging. Specifically, this study will investigate the validity of the Jawbone UP®, Fitbit Charge®, and SleepTime app in detecting sleep and wakefulness in comparison to conventional Polysomnography (PSG).
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Severe Sleep Apnea, Severe Insomnia, Epileptiform Activity
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
0 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Patients undergoing Polysomnography
Arm Type
Other
Intervention Type
Device
Intervention Name(s)
Polysomnography Data
Intervention Type
Device
Intervention Name(s)
Jawbone UP®
Intervention Type
Device
Intervention Name(s)
Fitbit Charge ®
Primary Outcome Measure Information:
Title
Time it takes subject to fall asleep
Time Frame
Up to 3 Months
Title
Number of Minutes of Sleep
Time Frame
Up to 3 Months
Title
Number of Arousals
Time Frame
Up to 3 Months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
Patients undergoing Polysomnography
Exclusion Criteria:
severe sleep apnea
severe insomnia with less than two hours of sleep per night
epileptiform activity
electrical status epilepticus of sleep
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Alcibiades Rodriguez
Organizational Affiliation
New York University Medical School
Official's Role
Principal Investigator
Facility Information:
Facility Name
New York University School of Medicine
City
New York
State/Province
New York
ZIP/Postal Code
10016
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Mainstream Sleep Tracking Devices vs Polysomnography
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