Mainstream Sleep Tracking Devices vs Polysomnography

April 25, 2017 updated by: NYU Langone Health

Sensitivity and Specificity of Mainstream Sleep Tracking Devices Compared to Polysomnography

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).

Study Overview

Status

Withdrawn

Conditions

Intervention / Treatment

Study Type

Interventional

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • New York
      • New York, New York, United States, 10016
        • New York University School of Medicine

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: Patients undergoing Polysomnography
Device: Polysomnography Data
Device: Jawbone UP®
Device: Fitbit Charge ®

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Time it takes subject to fall asleep
Time Frame: Up to 3 Months
Up to 3 Months
Number of Minutes of Sleep
Time Frame: Up to 3 Months
Up to 3 Months
Number of Arousals
Time Frame: Up to 3 Months
Up to 3 Months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

NYU Langone Health

Investigators

  • Principal Investigator: Alcibiades Rodriguez, New York University Medical School

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 1, 2016

Primary Completion (Actual)

April 1, 2017

Study Completion (Actual)

April 1, 2017

Study Registration Dates

First Submitted

April 13, 2016

First Submitted That Met QC Criteria

April 15, 2016

First Posted (Estimate)

April 20, 2016

Study Record Updates

Last Update Posted (Actual)

April 27, 2017

Last Update Submitted That Met QC Criteria

April 25, 2017

Last Verified

April 1, 2017

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 15-00071

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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