Repeating Patterns of Sleep Restriction and Recovery
2 other identifiers
interventional
17
1 country
1
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable healthy
Started Aug 2011
Longer than P75 for not_applicable healthy
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
August 1, 2011
CompletedFirst Submitted
Initial submission to the registry
November 30, 2011
CompletedFirst Posted
Study publicly available on registry
February 1, 2012
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2015
CompletedStudy Completion
Last participant's last visit for all outcomes
June 1, 2016
CompletedMarch 14, 2017
March 1, 2017
4.3 years
November 30, 2011
March 10, 2017
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
stress-related markers
cortisol, ACTH, norepinephrine, IL-6, COX in blood/urine, among others
Participants will be followed for the duration of hospital stay, an axpected average of 2 x 25 days.
Secondary Outcomes (1)
subjective stress-related markers
Participants will be followed for the duration of hospital stay, an axpected average of 2 x 25 days.
Study Arms (2)
repeated sleep restriction and recovery
EXPERIMENTALcontrol sleep
EXPERIMENTALInterventions
Repeated cycles of sleep restriction and sleep recovery
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Beth Israel Deaconess Medical Center
Boston, Massachusetts, 02215, United States
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Monika Haack, PhD
Beth Israel Deaconess Medical Center
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- BASIC SCIENCE
- Intervention Model
- CROSSOVER
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Assistant Professor of Neurology
Study Record Dates
First Submitted
November 30, 2011
First Posted
February 1, 2012
Study Start
August 1, 2011
Primary Completion
December 1, 2015
Study Completion
June 1, 2016
Last Updated
March 14, 2017
Record last verified: 2017-03