Comparison Between Multiple Wrist-worn Actigraphy Devices and Polysomnography

Insomnia Clinical Trial

Official title:

Comparison Between Multiple Wrist-worn Actigraphy Devices and Polysomnography

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT02463461
• Other study ID #: 1406015180
• Status: Withdrawn
• Phase: N/A
• First received: January 13, 2015
• Last updated: May 8, 2017
• Start date: August 2015
• Est. completion date: August 2017

Study information

• Verified date: May 2017
• Source: Weill Medical College of Cornell University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: August 2017
• Est. primary completion date: July 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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.

Related Conditions & MeSH terms

• Insomnia

Intervention

Device:
• ActiSleep Activity Monitor
Subjects in this group will wear a ActiSleep Activity Monitor.
• Jawbone Activity Monitor
Subjects in this group will wear a Jawbone Activity Monitor.
• Actiwatch 2 Activity Monitor
Subjects in this group will wear a Actiwatch 2 Activity Monitor.
• FitBit Activity Monitor
Subjects in this group will wear a FitBit Activity Monitor.
• Actigraph by Ambulatory Monitoring Activity Monitor
Subjects in this group will wear a Actigraph by Ambulatory Monitoring Activity Monitor.

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
Weill Medical College of Cornell University	Weill Cornell Medical College in Qatar

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Wake After Sleep Onset (WASO)	(Wake After Sleep Onset) Total minutes of wakefulness recorded after Sleep Onset, as scored by epochs.	1 Year