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

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.

Study Overview

• Status: Completed
• Conditions: Sleep Disorders
• Intervention / Treatment: Device: Wrist Actigraphy(motion sensors)with light sensors-Jawbone Up 2

Detailed Description

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.

• Study Type: Observational
• Enrollment (Actual): 69

Contacts and Locations

Study Locations

• China
  • Shanghai
    • Shanghai, Shanghai, China, 200025
      • Shanghai Jiao Tong University School of Medicine

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Overweight and obese adults with sleep disorders

Description

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

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Total Sleep Time, TST	10 hrs
Wake After Sleep Onset, WASO	10 hrs

Secondary Outcome Measures

Outcome Measure	Time Frame
Sleep Onset Latency, SOL	10 hrs
Frequency of arousal during sleep,awakenings	10 hrs
Sleep Efficiency, SE	10 hrs

Collaborators and Investigators

• Sponsor: Shanghai Jiao Tong University School of Medicine
• Collaborators: Ruijin Hospital

Study record dates

Study Major Dates

• Study Start: January 1, 2014
• Primary Completion (Actual): October 1, 2014
• Study Completion (Actual): October 1, 2014

Study Registration Dates

• First Submitted: October 5, 2014
• First Submitted That Met QC Criteria: October 8, 2014
• First Posted (Estimate): October 9, 2014

Study Record Updates

• Last Update Posted (Estimate): December 3, 2014
• Last Update Submitted That Met QC Criteria: December 2, 2014
• Last Verified: December 1, 2014

More Information

Terms related to this study

• Keywords: sleep disorders; Actigraphy; overweight and obese adults
• Additional Relevant MeSH Terms: Mental Disorders; Pathologic Processes; Nervous System Diseases; Neurologic Manifestations; Body Weight; Disease; Sleep Wake Disorders; Parasomnias; Overweight
• Other Study ID Numbers: CCEMD-023