Repeating Patterns of Sleep Restriction and Recovery

Repeating Patterns of Sleep Restriction and Recovery - do we Get Used to it?

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.

Study Overview

• Status: Completed
• Conditions: Healthy
• Intervention / Treatment: Behavioral: Repeated sleep restriction and recovery; Behavioral: Control sleep

• Study Type: Interventional
• Enrollment (Actual): 17
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Massachusetts
    • Boston, Massachusetts, United States, 02215
      • Beth Israel Deaconess Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 35 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Basic Science
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
subjective stress-related markers	Computerized rating scales for the assessment of physical and emotional well-being	Participants will be followed for the duration of hospital stay, an axpected average of 2 x 25 days.

Collaborators and Investigators

• Sponsor: Beth Israel Deaconess Medical Center
• Collaborators: National Heart, Lung, and Blood Institute (NHLBI)

Study record dates

Study Major Dates

• Study Start: August 1, 2011
• Primary Completion (Actual): December 1, 2015
• Study Completion (Actual): June 1, 2016

Study Registration Dates

• First Submitted: November 30, 2011
• First Submitted That Met QC Criteria: January 30, 2012
• First Posted (Estimate): February 1, 2012

Study Record Updates

• Last Update Posted (Actual): March 14, 2017
• Last Update Submitted That Met QC Criteria: March 10, 2017
• Last Verified: March 1, 2017

More Information

Terms related to this study

• Keywords: Healthy individuals
• Other Study ID Numbers: 2010P000399; R01HL105544-01A1 (U.S. NIH Grant/Contract)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No