Mainstream Sleep Tracking Devices vs Polysomnography

• Sponsor: NYU Langone Health (Other)
• Overall Status: Withdrawn
• CT.gov ID: NCT02744235
• Collaborator: (none)
• Enrollment: 0
• Location: 1
• Arm: 1
• Actual Duration (Months): 13
• Patients Per Site Per Month: 0

Study Details

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).

Condition or Disease	Intervention/Treatment	Phase
Severe Sleep Apnea; Severe Insomnia; Epileptiform Activity	Device: Polysomnography Data; Device: Jawbone UP®; Device: Fitbit Charge ®	N/A

Study Design

• Study Type: Interventional
• Actual Enrollment: 0 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Diagnostic
• Official Title: Sensitivity and Specificity of Mainstream Sleep Tracking Devices Compared to Polysomnography
• Actual Study Start Date: Mar 1, 2016
• Actual Primary Completion Date: Apr 1, 2017
• Actual Study Completion Date: Apr 1, 2017

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

1. Time it takes subject to fall asleep [Up to 3 Months]

2. Number of Minutes of Sleep [Up to 3 Months]

3. Number of Arousals [Up to 3 Months]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 65 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	New York University School of Medicine	New York	New York	United States	10016

Sponsors and Collaborators

• NYU Langone Health

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: NYU Langone Health
• ClinicalTrials.gov Identifier: NCT02744235
• Other Study ID Numbers: 15-00071
• First Posted: Apr 20, 2016
• Last Update Posted: Apr 27, 2017
• Last Verified: Apr 1, 2017

• Additional relevant MeSH terms: Sleep Apnea Syndromes; Sleep Initiation and Maintenance Disorders

Study Results

No Results Posted as of Apr 27, 2017