Repeating Patterns of Sleep Restriction and Recovery

NCT ID: NCT01523691

Last Updated: 2017-03-14

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

17 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-08-31

Study Completion Date

2016-06-30

Brief Summary

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Goal of this study is to test the hypothesis that repeated exposure to cycles of insufficient sleep increases susceptibility to a variety of disease states by progressively compromising the integrity of stress response systems.

Detailed Description

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Conditions

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Healthy

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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repeated sleep restriction and recovery

Group Type EXPERIMENTAL

Repeated sleep restriction and recovery

Intervention Type BEHAVIORAL

Repeated cycles of sleep restriction and sleep recovery

control sleep

Group Type EXPERIMENTAL

Control sleep

Intervention Type BEHAVIORAL

Regular amounts of sleep across study protocol

Interventions

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Repeated sleep restriction and recovery

Repeated cycles of sleep restriction and sleep recovery

Intervention Type BEHAVIORAL

Control sleep

Regular amounts of sleep across study protocol

Intervention Type BEHAVIORAL

Eligibility Criteria

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Inclusion Criteria

* Body mass index (BMI) between 18.5 and 30 kg/m2
* For female participants: regular menstrual cycles
* Daily sleep duration in the normal range
* Blood chemistry in the normal range

Exclusion Criteria

* Active infection/disease
* History of psychiatric, neurological, pain-related, immune, or cardiovascular disease; significant allergy
* Pregnant/nursing
* Respiratory disturbance index of \>5 events/hour on polysomnographic sleep study, leg movements with arousal \>10/hour; sleep efficiency \<80%
* Regular medication use other than oral contraceptives
* Donation of blood or platelets 3 month prior to or in-between study arms
Minimum Eligible Age

18 Years

Maximum Eligible Age

35 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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National Heart, Lung, and Blood Institute (NHLBI)

NIH

Sponsor Role collaborator

Beth Israel Deaconess Medical Center

OTHER

Sponsor Role lead

Responsible Party

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Monika Haack

Assistant Professor of Neurology

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Monika Haack, PhD

Role: PRINCIPAL_INVESTIGATOR

Beth Israel Deaconess Medical Center

Locations

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Beth Israel Deaconess Medical Center

Boston, Massachusetts, United States

Site Status

Countries

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United States

Other Identifiers

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R01HL105544-01A1

Identifier Type: NIH

Identifier Source: secondary_id

View Link

2010P000399

Identifier Type: -

Identifier Source: org_study_id

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