NCT02854709

Brief Summary

This is a randomized cross over study of the effect of 2-week sleep extension in chronically sleep deprived non-diabetic individuals on glucose metabolism.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
21

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jul 2016

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

July 1, 2016

Completed
29 days until next milestone

First Submitted

Initial submission to the registry

July 30, 2016

Completed
4 days until next milestone

First Posted

Study publicly available on registry

August 3, 2016

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2017

Completed
Last Updated

July 18, 2017

Status Verified

July 1, 2017

Enrollment Period

11 months

First QC Date

July 30, 2016

Last Update Submit

July 17, 2017

Conditions

Sleep ExtensionGlucose Metabolism

Outcome Measures

Primary Outcomes (1)

  • Glucose metabolism

    Glucose and insulin values from 75 gram OGTT

    2 weeks

Study Arms (2)

Control

NO INTERVENTION

Continue with habitual sleep duration

Intervention

EXPERIMENTAL

Sleep extension

Behavioral: Sleep extension

Interventions

Sleep extensionBEHAVIORAL

Sleep extension by 1 hour for 2 weeks

Intervention

Eligibility Criteria

Age20 Years - 55 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • self-reported sleep duration =\<6 hours/night during the week with a desire to sleep at least 7 hours/night

You may not qualify if:

  • shift workers,
  • diabetes history,
  • drugs affecting sleep or glucose metabolism,
  • insomnia symptoms,
  • high risk for sleep apnea,
  • smoking or excess alcohol use

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Faculty of Medicine Ramathibodi Hospital

Bangkok, 10400, Thailand

Location

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

July 30, 2016

First Posted

August 3, 2016

Study Start

July 1, 2016

Primary Completion

June 1, 2017

Study Completion

June 1, 2017

Last Updated

July 18, 2017

Record last verified: 2017-07

Locations

TH(1)