Comparison Between Multiple Wrist-worn Actigraphy Devices and Polysomnography

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).

Study Overview

• Status: Withdrawn
• Conditions: Insomnia
• Intervention / Treatment: Device: ActiSleep Activity Monitor; Device: Jawbone Activity Monitor; Device: Actiwatch 2 Activity Monitor; Device: FitBit Activity Monitor; Device: Actigraph by Ambulatory Monitoring Activity Monitor

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.

• Study Type: Interventional
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

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

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

5

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: ActiSleep Activity Monitor; Subjects placed in this group will given an ActiSleep Activity Monitor for the one night of the study.	Device: ActiSleep Activity Monitor; Subjects in this group will wear a ActiSleep Activity Monitor.
Experimental: Jawbone Activity Monitor; Subjects placed in this group will given a Jawbone Activity Monitor for the one night of the study.	Device: Jawbone Activity Monitor; Subjects in this group will wear a Jawbone Activity Monitor.
Experimental: Actiwatch 2 Activity Monitor; Subjects placed in this group will given an Actiwatch 2 Activity Monitor for the one night of the study.	Device: Actiwatch 2 Activity Monitor; Subjects in this group will wear a Actiwatch 2 Activity Monitor.
Experimental: FitBit Activity Monitor; Subjects placed in this group will given a FitBit Activity Monitor for the one night of the study.	Device: FitBit Activity Monitor; Subjects in this group will wear a FitBit Activity Monitor.
Experimental: 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.	Device: Actigraph by Ambulatory Monitoring Activity Monitor; Subjects in this group will wear a Actigraph by Ambulatory Monitoring Activity Monitor.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Wake After Sleep Onset (WASO)	(Wake After Sleep Onset) Total minutes of wakefulness recorded after Sleep Onset, as scored by epochs.	1 Year

Collaborators and Investigators

• Sponsor: Weill Medical College of Cornell University
• Collaborators: Weill Cornell Medical College in Qatar
• Investigators: Principal Investigator: Ana Krieger, Weill Medical College of Cornell University

Study record dates

Study Major Dates

• Study Start: August 1, 2015
• Primary Completion (Anticipated): July 1, 2017
• Study Completion (Anticipated): August 1, 2017

Study Registration Dates

• First Submitted: January 13, 2015
• First Submitted That Met QC Criteria: June 3, 2015
• First Posted (Estimate): June 4, 2015

Study Record Updates

• Last Update Posted (Actual): May 10, 2017
• Last Update Submitted That Met QC Criteria: May 8, 2017
• Last Verified: May 1, 2017

More Information

Terms related to this study

• Other Study ID Numbers: 1406015180

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Undecided