Comparison Between Multiple Wrist-worn Actigraphy Devices and Polysomnography

Not Applicable

Withdrawn

• Conditions: Insomnia
• Interventions: Device: ActiSleep Activity Monitor; Device: Actiwatch 2 Activity Monitor; Device: Jawbone Activity Monitor; Device: FitBit Activity Monitor; Device: Actigraph by Ambulatory Monitoring Activity Monitor

• Registration Number: NCT02463461
• Lead Sponsor: Weill Medical College of Cornell University

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).

Detailed Description

The importance of sleep upon physiological and psychological health has been extensively documented. It has been proposed that adequate sleep, as well as good sleep quality, is vital for wellbeing. (1). Some have suggested that sleep curtailment has paralleled the increased prevalence of cardiometabolic disease including obesity (2), type 2 diabetes mellitus (3, 4), hypertension (5, 6) and more. Sleep researchers face a major challenge since there are multiple methods for sleep assessment, all of which have advantages and disadvantages.Whilst polysomnography (PSG) is considered to be the gold standard for sleep assessment, there are some limitations including laboratory attendance for the participant and sleep scoring variance. Sleep questionnaires are widely utilized, particularly in large epidemiological studies, but are susceptible to inaccuracies and some have not been validated against PSG. Wrist actigraphy has provided researchers with an attractive equivalent and there are now multiple commercial manufacturers available. Actigraphic devices are usually worn on the non-dominant wrist and the instrument is used to monitor wrist movements through the use of an accelerometer and a memory chip. Wrist actigraphy is useful in the detection of sleep, wake, and activity.

Basic Information
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Recruitment & Eligibility
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Study & Design

Study Timeline

• Study First Submitted: 2015-01-13
• Study First Submitted QC: 2015-06-03
• Study First Posted: 2015-06-04
• Study Start: 2015-08
• Status Verified: 2017-05
• Last Update Submitted: 2017-05-08
• Last Update Posted: 2017-05-10
• Primary Completion: 2017-07
• Study Completion: 2017-08

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

• Attending a regularly scheduled Polysomnography test at Weill Cornell Medical College. Male or female. 18-80 years old

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Exclusion Criteria

• 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.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
ActiSleep Activity Monitor	ActiSleep Activity Monitor	Subjects placed in this group will given an ActiSleep Activity Monitor for the one night of the study.
Actiwatch 2 Activity Monitor	Actiwatch 2 Activity Monitor	Subjects placed in this group will given an Actiwatch 2 Activity Monitor for the one night of the study.
Jawbone Activity Monitor	Jawbone Activity Monitor	Subjects placed in this group will given a Jawbone Activity Monitor for the one night of the study.
FitBit Activity Monitor	FitBit Activity Monitor	Subjects placed in this group will given a FitBit Activity Monitor for the one night of the study.
Actigraph by Ambulatory Monitoring Activity Monitor	Actigraph by Ambulatory Monitoring Activity Monitor	Subjects placed in this group will given an Actigraph by Ambulatory Monitoring Activity Monitor for the one night of the study.

Primary Outcome Measures

Name	Time	Method
Total sleep time (TST)	1 night	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.

Secondary Outcome Measures

Name	Time	Method
Wake After Sleep Onset (WASO)	1 Year	(Wake After Sleep Onset) Total minutes of wakefulness recorded after Sleep Onset, as scored by epochs.