Home Sleep and Metabolism

NCT ID: NCT02253368

Last Updated: 2021-02-05

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

210 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-11-30

Study Completion Date

2020-10-31

Brief Summary

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Bedtimes and wake-up times vary from person to person. The aim of this research is to examine the associations between sleep habits and metabolism in healthy people. In this study, the investigators will collect information on sleep-wake habits and how the body uses energy.

Detailed Description

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Conditions

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Overweight Sleep

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

OTHER

Blinding Strategy

SINGLE

Participants

Study Groups

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Sleep Arm 1

Sleep Arm 1

Group Type ACTIVE_COMPARATOR

sleep

Intervention Type OTHER

Sleep Arm 2

Sleep Arm 2

Group Type ACTIVE_COMPARATOR

sleep

Intervention Type OTHER

Interventions

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sleep

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* Age: 21-40 years
* Body mass index: 25.0 to 29.9 kg/m2
* Average habitual sleep duration of 6.5 hours or less per night (as confirmed by actigraphy)
* stable sleep habits for the past 6 months

Exclusion Criteria

* obstructive sleep apnea or history of any other sleep disorder
* night or rotating shift work (current or in the past 2 years)
* habitual daytime naps
* recent (\< 4 week) travel across time zones
* extreme chronotypes
* any acute or chronic medical condition
* diabetes
* prior or current eating or psychiatric disorders
* claustrophobia
* irregular menstrual periods, menopause, pregnancy,
* alcohol abuse, excessive caffeine intake, smoking, illegal drug use
* subjects who are currently following a weight loss regimen or any other special diet or exercise programs
* subjects who have received iv or oral contrast in the past 2 weeks
* use of any prescription medication that can affect sleep or metabolism with the exception of antihypertensive and lipid lowering agents as follows. Subjects who are taking anti-hypertensive medication and/or lipid-lowering agents will be included only if they are well controlled and on a stable regimen (no change in medications in the previous 3 months). However, beta-blockers and thiazide diuretics will not be allowed, as these medications are known to affect insulin sensitivity. Women will be required to not be on hormone replacement therapy.
Minimum Eligible Age

21 Years

Maximum Eligible Age

40 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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University of Chicago

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Esra Tasali, MD

Role: PRINCIPAL_INVESTIGATOR

University of Chicago

Locations

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University of Chicago

Chicago, Illinois, United States

Site Status

Countries

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United States

References

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Tasali E, Wroblewski K, Kahn E, Kilkus J, Schoeller DA. Effect of Sleep Extension on Objectively Assessed Energy Intake Among Adults With Overweight in Real-life Settings: A Randomized Clinical Trial. JAMA Intern Med. 2022 Apr 1;182(4):365-374. doi: 10.1001/jamainternmed.2021.8098.

Reference Type DERIVED
PMID: 35129580 (View on PubMed)

Provided Documents

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Document Type: Informed Consent Form

View Document

Other Identifiers

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IRB14-0528

Identifier Type: -

Identifier Source: org_study_id

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