A Study of Wrist Actigraphy in Overweight and Obese Adults With Sleep Disorders

NCT ID: NCT02260297

Last Updated: 2014-12-03

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

69 participants

Study Classification

OBSERVATIONAL

Study Start Date

2014-01-31

Study Completion Date

2014-10-31

Brief Summary

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70 overweight or obese adults with sleep disorders will be recruited for this study, in which the investigators aim to compare wrist actigraphy with polysomnography (PSG) for sleep monitoring. It is to evaluate the applications of Jawbone Up2 with the sleep parameters derived from this actigraphy.

Detailed Description

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As an observation study, it will recruit 70 overweight or obese patients with sleep disorders who meet the selection criteria: clinical records and AIS at a tertiary hospital. The patients will sign the informed consent form. The involved patients and doctors will receive related training.

These patients will receive the sleep monitoring from 21:00 to 6:00 in sleep monitoring laboratory in Ruijin Hospital. They will receive the PSG and Jawbone Up 2 sleep monitoring at the same time. Sleep parameters derived from actigraphy and PSG will be compared in multiple night recordings such as total sleep time, wake after sleep onset, sleep onset latency, awakening, sleep efficiency, total time in bed,. The aim is to assess the validation of actigraphy in overweight or obese patients with sleep disorders.

Conditions

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Sleep Disorders

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Interventions

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Wrist Actigraphy(motion sensors)with light sensors-Jawbone Up 2

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

* 18 years of age or older
* Have one or more sleep disorders such as consecutive snoring, insomnia, sleep apnea, narcolepsy, delayed sleep phase syndrome
* Athens Insomnia Scale (AIS)\>6
* BMI\>25
* Agree to participate in the study and have signed the inform consent form

Exclusion Criteria

* Terminal illness
* Physically-challenged and paralyzed patients
* Intend to receive selective surgery, to get pregnancy and breast feeding in three months
* Long-term use of the sleeping pills
* Hearing loss or severe visual disorder;
* Mental disorders
* Dementia or communication disorders
* Unable to complete an all night sleep monitoring
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Ruijin Hospital

OTHER

Sponsor Role collaborator

Shanghai Jiao Tong University School of Medicine

OTHER

Sponsor Role lead

Responsible Party

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Guang Ning

Shanghai Jiao Tong University School of Medicine

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Shanghai Jiao Tong University School of Medicine

Shanghai, Shanghai Municipality, China

Site Status

Countries

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China

Other Identifiers

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CCEMD-023

Identifier Type: -

Identifier Source: org_study_id