Repeating Patterns of Sleep Restriction and Recovery

This study is currently recruiting participants.

Verified January 2012 by Beth Israel Deaconess Medical Center

Sponsor:

Information provided by (Responsible Party):

Beth Israel Deaconess Medical Center

ClinicalTrials.gov Identifier:

NCT01523691

First received: November 30, 2011

Last updated: January 30, 2012

Last verified: January 2012

History of Changes

Purpose

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.

Condition	Intervention
Healthy	Behavioral: Repeated sleep restriction and recovery Behavioral: Control sleep

Study Type:	Interventional
Study Design:	Allocation: Randomized Intervention Model: Crossover Assignment Masking: Double Blind (Subject, Investigator) Primary Purpose: Basic Science
Official Title:	Repeating Patterns of Sleep Restriction and Recovery - do we Get Used to it?

Further study details as provided by Beth Israel Deaconess Medical Center:

Primary Outcome Measures:

stress-related markers [ Time Frame: Participants will be followed for the duration of hospital stay, an axpected average of 2 x 25 days. ] [ Designated as safety issue: No ]
cortisol, ACTH, norepinephrine, IL-6, COX in blood/urine, among others

Secondary Outcome Measures:

subjective stress-related markers [ Time Frame: Participants will be followed for the duration of hospital stay, an axpected average of 2 x 25 days. ] [ Designated as safety issue: No ]
Computerized rating scales for the assessment of physical and emotional well-being

Estimated Enrollment:	14
Study Start Date:	August 2011
Estimated Study Completion Date:	June 2016
Estimated Primary Completion Date:	December 2015 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: repeated sleep restriction and recovery	Behavioral: Repeated sleep restriction and recovery Repeated cycles of sleep restriction and sleep recovery
Experimental: control sleep	Behavioral: Control sleep Regular amounts of sleep across study protocol

Eligibility

Ages Eligible for Study:	18 Years to 35 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	Yes

Criteria

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT01523691

Contacts

Contact: Caitlin Estes, BS

617-667-0308

194haack@bidmc.harvard.edu

Locations

United States, Massachusetts
Beth Israel Deaconess Medical Center	Recruiting
Boston, Massachusetts, United States, 02215
Contact: Caitlin Estes, BS 617-667-0308 N194haack@bidmc.harvard.edu
Principal Investigator: Monika Haack, PhD

Sponsors and Collaborators

Beth Israel Deaconess Medical Center

Investigators

Principal Investigator:

Monika Haack, PhD

Beth Israel Deaconess Medical Center

More Information

No publications provided

Responsible Party:	Beth Israel Deaconess Medical Center
ClinicalTrials.gov Identifier:	NCT01523691 History of Changes
Other Study ID Numbers:	HL105544-01A1
Study First Received:	November 30, 2011
Last Updated:	January 30, 2012
Health Authority:	United States: Institutional Review Board

Keywords provided by Beth Israel Deaconess Medical Center:

Healthy individuals

ClinicalTrials.gov processed this record on May 16, 2013

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