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NCT Number: NCT02260297

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.

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Key information

Conditions

Sleep Disorders Body Weight Mental Disorders Nervous System Diseases Neurologic Manifestations Nutrition Disorders Nutritional and Metabolic Diseases Overnutrition Overweight Pathological Conditions, Signs and Symptoms Signs and Symptoms Sleep Wake Disorders

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Shanghai Jiao Tong University School of Medicine

Shanghai, Shanghai Municipality, 200025, China

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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

Device

Primary outcomes

  1. Total Sleep Time, TST

    Time frame: 10 hrs

  2. Wake After Sleep Onset, WASO

    Time frame: 10 hrs

Secondary outcomes

  1. Sleep Onset Latency, SOL

    Time frame: 10 hrs

  2. Frequency of arousal during sleep,awakenings

    Time frame: 10 hrs

  3. Sleep Efficiency, SE

    Time frame: 10 hrs

Sponsors and collaborators

Lead sponsor

Shanghai Jiao Tong University School of Medicine

Other

Collaborators

  • Ruijin Hospital

Registry information

Important dates

Study start
2014
Primary completion
2014
Study completion
2014
First posted
Oct 9, 2014
Registry last updated
Dec 3, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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