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

Sleep Disorders Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02260297
• Other study ID #: CCEMD-023
• Status: Completed
• Phase: N/A
• First received: October 5, 2014
• Last updated: December 2, 2014
• Start date: January 2014
• Est. completion date: October 2014

Study information

• Verified date: December 2014
• Source: Shanghai Jiao Tong University School of Medicine
• Contact: n/a
• Is FDA regulated: No
• Health authority: China: Ministry of Health
• Study type: Observational

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 69
• Est. completion date: October 2014
• Est. primary completion date: October 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Overweight
• Parasomnias
• Sleep Disorders

Intervention

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

Locations

Country	Name	City	State
China	Shanghai Jiao Tong University School of Medicine	Shanghai	Shanghai

Sponsors (2)

Lead Sponsor	Collaborator
Shanghai Jiao Tong University School of Medicine	Ruijin Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Total Sleep Time, TST		10 hrs	No
Primary	Wake After Sleep Onset, WASO		10 hrs	No
Secondary	Sleep Onset Latency, SOL		10 hrs	No
Secondary	Frequency of arousal during sleep,awakenings		10 hrs	No
Secondary	Sleep Efficiency, SE		10 hrs	No