NCT02463461

Comparison Between Multiple Wrist-worn Actigraphy Devices and Polysomnography

• Status: Withdrawn
• Phase: N/A
• Study type: Interventional
• Enrollment: 0 (actual)
• Sponsor: Weill Medical College of Cornell University · Academic / Other
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Insomnia

Interventions

Type	Name	Description
DEVICE	ActiSleep Activity Monitor	Subjects in this group will wear a ActiSleep Activity Monitor.
DEVICE	Jawbone Activity Monitor	Subjects in this group will wear a Jawbone Activity Monitor.
DEVICE	Actiwatch 2 Activity Monitor	Subjects in this group will wear a Actiwatch 2 Activity Monitor.
DEVICE	FitBit Activity Monitor	Subjects in this group will wear a FitBit Activity Monitor.
DEVICE	Actigraph by Ambulatory Monitoring Activity Monitor	Subjects in this group will wear a Actigraph by Ambulatory Monitoring Activity Monitor.

Timeline

• Start date: 2015-08-01
• Primary completion: 2017-07-01
• Completion: 2017-08-01
• First posted: 2015-06-04
• Last updated: 2017-05-10