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Comparison Between Multiple Wrist-worn Actigraphy Devices and Polysomnography

Comparison Between Multiple Wrist-worn Actigraphy Devices and Polysomnography

Status
Withdrawn
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02463461
Enrollment
0
Registered
2015-06-04
Start date
2015-08-31
Completion date
2017-08-31
Last updated
2017-05-10

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Insomnia

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.

Interventions

DEVICEActiSleep Activity Monitor

Subjects in this group will wear a ActiSleep Activity Monitor.

DEVICEJawbone Activity Monitor

Subjects in this group will wear a Jawbone Activity Monitor.

DEVICEActiwatch 2 Activity Monitor

Subjects in this group will wear a Actiwatch 2 Activity Monitor.

Subjects in this group will wear a FitBit Activity Monitor.

DEVICEActigraph by Ambulatory Monitoring Activity Monitor

Subjects in this group will wear a Actigraph by Ambulatory Monitoring Activity Monitor.

Sponsors

Weill Cornell Medical College in Qatar
CollaboratorOTHER
Weill Medical College of Cornell University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
DIAGNOSTIC
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frameDescription
Total sleep time (TST)1 nightThe 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

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

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026