Overview

This trial is active, not recruiting.

Condition healthy
Treatments repeated sleep restriction and recovery, control sleep
Sponsor Beth Israel Deaconess Medical Center
Start date August 2011
End date December 2015
Trial size 14 participants
Trial identifier NCT01523691, HL105544-01A1 2010P-000399

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Intervention model crossover assignment
Masking double blind (subject, investigator)
Primary purpose basic science
Arm
(Experimental)
repeated sleep restriction and recovery
Repeated cycles of sleep restriction and sleep recovery
(Experimental)
control sleep
Regular amounts of sleep across study protocol

Primary Outcomes

Measure
stress-related markers
time frame: Participants will be followed for the duration of hospital stay, an axpected average of 2 x 25 days.

Secondary Outcomes

Measure
subjective stress-related markers
time frame: Participants will be followed for the duration of hospital stay, an axpected average of 2 x 25 days.

Eligibility Criteria

Male or female participants from 18 years up to 35 years old.

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

Additional Information

Official title Repeating Patterns of Sleep Restriction and Recovery - do we Get Used to it?
Principal investigator Monika Haack, PhD
Trial information was received from ClinicalTrials.gov and was last updated in November 2015.
Information provided to ClinicalTrials.gov by Beth Israel Deaconess Medical Center.