NCT02260297

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
69

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Jan 2014

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2014

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2014

Completed
4 days until next milestone

First Submitted

Initial submission to the registry

October 5, 2014

Completed
4 days until next milestone

First Posted

Study publicly available on registry

October 9, 2014

Completed
Last Updated

December 3, 2014

Status Verified

December 1, 2014

Enrollment Period

9 months

First QC Date

October 5, 2014

Last Update Submit

December 2, 2014

Conditions

Sleep Disorders

Keywords

Actigraphyoverweight and obese adultssleep disorders

Outcome Measures

Primary Outcomes (2)

  • Total Sleep Time, TST

    10 hrs

  • Wake After Sleep Onset, WASO

    10 hrs

Secondary Outcomes (3)

  • Sleep Onset Latency, SOL

    10 hrs

  • Frequency of arousal during sleep,awakenings

    10 hrs

  • Sleep Efficiency, SE

    10 hrs

Interventions

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

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Overweight and obese adults with sleep disorders

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Shanghai Jiao Tong University School of Medicine

Shanghai, Shanghai Municipality, 200025, China

Location

MeSH Terms

Conditions

Sleep Wake DisordersOverweight

Condition Hierarchy (Ancestors)

Nervous System DiseasesNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and SymptomsMental DisordersOvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody Weight

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Shanghai Jiao Tong University School of Medicine

Study Record Dates

First Submitted

October 5, 2014

First Posted

October 9, 2014

Study Start

January 1, 2014

Primary Completion

October 1, 2014

Study Completion

October 1, 2014

Last Updated

December 3, 2014

Record last verified: 2014-12

Locations

CN(1)