NCT02744235

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).

Trial Health

30
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Timeline
Completed

Started Mar 2016

Geographic Reach
1 country

1 active site

Status
withdrawn

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2016

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

April 13, 2016

Completed
7 days until next milestone

First Posted

Study publicly available on registry

April 20, 2016

Completed
12 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2017

Completed
Last Updated

April 27, 2017

Status Verified

April 1, 2017

Enrollment Period

1.1 years

First QC Date

April 13, 2016

Last Update Submit

April 25, 2017

Conditions

Severe Sleep ApneaSevere InsomniaEpileptiform Activity

Outcome Measures

Primary Outcomes (3)

  • Time it takes subject to fall asleep

    Up to 3 Months

  • Number of Minutes of Sleep

    Up to 3 Months

  • Number of Arousals

    Up to 3 Months

Study Arms (1)

Patients undergoing Polysomnography

OTHER
Device: Polysomnography DataDevice: Jawbone UP®Device: Fitbit Charge ®

Interventions

Polysomnography DataDEVICE
Patients undergoing Polysomnography
Jawbone UP®DEVICE
Patients undergoing Polysomnography
Fitbit Charge ®DEVICE
Patients undergoing Polysomnography

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patients undergoing Polysomnography

You may not qualify if:

  • severe sleep apnea
  • severe insomnia with less than two hours of sleep per night
  • epileptiform activity
  • electrical status epilepticus of sleep

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

New York University School of Medicine

New York, New York, 10016, United States

Location

MeSH Terms

Conditions

Sleep Apnea SyndromesSleep Initiation and Maintenance Disorders

Condition Hierarchy (Ancestors)

ApneaRespiration DisordersRespiratory Tract DiseasesSleep Disorders, IntrinsicDyssomniasSleep Wake DisordersNervous System DiseasesMental Disorders

Study Officials

  • Alcibiades Rodriguez

    New York University Medical School

    PRINCIPAL INVESTIGATOR
0

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 13, 2016

First Posted

April 20, 2016

Study Start

March 1, 2016

Primary Completion

April 1, 2017

Study Completion

April 1, 2017

Last Updated

April 27, 2017

Record last verified: 2017-04

Locations

US(1)