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Comparison Between Multiple Wrist-worn Actigraphy Devices and Polysomnography
1 other identifier
interventional
N/A
0 countries
N/A
Brief Summary
The primary objective of the proposed study is to investigate the agreement levels of modern and well-established actigraphy devices against PSG in healthy as well as patient populations for multiple sleep parameters across two study sites (Qatar and New York City).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
Started Aug 2015
Typical duration for not_applicable
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
January 13, 2015
CompletedFirst Posted
Study publicly available on registry
June 4, 2015
CompletedStudy Start
First participant enrolled
August 1, 2015
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 1, 2017
CompletedStudy Completion
Last participant's last visit for all outcomes
August 1, 2017
CompletedMay 10, 2017
May 1, 2017
1.9 years
January 13, 2015
May 8, 2017
Conditions
Outcome Measures
Primary Outcomes (1)
Total sleep time (TST)
The amount of actually sleep time in a sleep episode; this time is equal to the total sleep episode less the awake time. TST is the total of all REM and NREM sleep in a sleep episode.
1 night
Secondary Outcomes (1)
Wake After Sleep Onset (WASO)
1 Year
Study Arms (5)
ActiSleep Activity Monitor
EXPERIMENTALSubjects placed in this group will given an ActiSleep Activity Monitor for the one night of the study.
Jawbone Activity Monitor
EXPERIMENTALSubjects placed in this group will given a Jawbone Activity Monitor for the one night of the study.
Actiwatch 2 Activity Monitor
EXPERIMENTALSubjects placed in this group will given an Actiwatch 2 Activity Monitor for the one night of the study.
FitBit Activity Monitor
EXPERIMENTALSubjects placed in this group will given a FitBit Activity Monitor for the one night of the study.
Actigraph by Ambulatory Monitoring Activity Monitor
EXPERIMENTALSubjects placed in this group will given an Actigraph by Ambulatory Monitoring Activity Monitor for the one night of the study.
Interventions
Subjects in this group will wear a ActiSleep Activity Monitor.
Subjects in this group will wear a Jawbone Activity Monitor.
Subjects in this group will wear a Actiwatch 2 Activity Monitor.
Subjects in this group will wear a FitBit Activity Monitor.
Subjects in this group will wear a Actigraph by Ambulatory Monitoring Activity Monitor.
Eligibility Criteria
You may qualify if:
- Attending a regularly scheduled Polysomnography test at Weill Cornell Medical College. Male or female. 18-80 years old
You may not qualify if:
- Not attending a regularly scheduled Polysomnography test at Weill Cornell Medical College. Under 18 or over 80 years old. Pregnancy. Unable to provide informed consent.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Ana Krieger
Weill Medical College of Cornell University
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- DIAGNOSTIC
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
January 13, 2015
First Posted
June 4, 2015
Study Start
August 1, 2015
Primary Completion
July 1, 2017
Study Completion
August 1, 2017
Last Updated
May 10, 2017
Record last verified: 2017-05