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Repeating Patterns of Sleep Restriction and Recovery

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01523691
First Posted: February 1, 2012
Last Update Posted: March 14, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
National Heart, Lung, and Blood Institute (NHLBI)
Information provided by (Responsible Party):
Monika Haack, Beth Israel Deaconess Medical Center
  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 (Participant, 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 Monika Haack, 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. ]
    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. ]
    Computerized rating scales for the assessment of physical and emotional well-being


Enrollment: 17
Study Start Date: August 2011
Study Completion Date: June 2016
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

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years to 35 Years   (Adult)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01523691


Locations
United States, Massachusetts
Beth Israel Deaconess Medical Center
Boston, Massachusetts, United States, 02215
Sponsors and Collaborators
Beth Israel Deaconess Medical Center
National Heart, Lung, and Blood Institute (NHLBI)
Investigators
Principal Investigator: Monika Haack, PhD Beth Israel Deaconess Medical Center
  More Information

Responsible Party: Monika Haack, Assistant Professor of Neurology, Beth Israel Deaconess Medical Center
ClinicalTrials.gov Identifier: NCT01523691     History of Changes
Other Study ID Numbers: 2010P000399
R01HL105544-01A1 ( U.S. NIH Grant/Contract )
First Submitted: November 30, 2011
First Posted: February 1, 2012
Last Update Posted: March 14, 2017
Last Verified: March 2017

Keywords provided by Monika Haack, Beth Israel Deaconess Medical Center:
Healthy individuals