Comparison Between Multiple Wrist-worn Actigraphy Devices and Polysomnography
May 8, 2017 updated by: Weill Medical College of Cornell University
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Withdrawn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
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
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
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
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Diagnostic
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
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.
|
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.
|
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.
|
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.
|
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.
|
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)
Time Frame: 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.
|
1 night
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Wake After Sleep Onset (WASO)
Time Frame: 1 Year
|
(Wake After Sleep Onset) Total minutes of wakefulness recorded after Sleep Onset, as scored by epochs.
|
1 Year
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Collaborators
Investigators
- Principal Investigator: Ana Krieger, Weill Medical College of Cornell University
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
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
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.