Repeating Patterns of Sleep Restriction and Recovery

Not Applicable

Completed

• Conditions: Healthy
• Interventions: Behavioral: Control sleep; Behavioral: Repeated sleep restriction and recovery

• Registration Number: NCT01523691
• Lead Sponsor: Beth Israel Deaconess Medical Center

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2011-08
• Study First Submitted: 2011-11-30
• Study First Submitted QC: 2012-01-30
• Study First Posted: 2012-02-01
• Primary Completion: 2015-12
• Study Completion: 2016-06
• Status Verified: 2017-03
• Last Update Submitted: 2017-03-10
• Last Update Posted: 2017-03-14

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 17

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
control sleep	Control sleep	-
repeated sleep restriction and recovery	Repeated sleep restriction and recovery	-

Primary Outcome Measures

Name	Time	Method
stress-related markers	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

Name	Time	Method
subjective stress-related markers	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

Trial Locations

Locations (1)

Beth Israel Deaconess Medical Center; 🇺🇸 Boston, Massachusetts, United States