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
  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 April 16, 2014