Repeating Patterns of Sleep Restriction and Recovery

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Beth Israel Deaconess Medical Center
ClinicalTrials.gov Identifier:
NCT01523691
First received: November 30, 2011
Last updated: October 7, 2014
Last verified: October 2014
  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
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, see Learn About Clinical Studies.

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

Locations
United States, Massachusetts
Beth Israel Deaconess Medical Center
Boston, Massachusetts, United States, 02215
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: October 7, 2014
Health Authority: United States: Institutional Review Board

Keywords provided by Beth Israel Deaconess Medical Center:
Healthy individuals

ClinicalTrials.gov processed this record on October 23, 2014