Chronic Sleep Restriction (CSR)

February 2, 2016 updated by: Marco Tulio de Mello, Federal University of São Paulo

Chronic Sleep Restriction: Neurobehavioral and Physiological Responses

Sleep is a physiological state considered essential for health and human survival. The prevalence of chronic sleep restriction has increased in modern society, as well as the effects of the same health concerns about various aspects, including the physiological and neurobehavioral. The objective of this study is to identify the neurobehavioral and physiological responses of healthy men with different needs of total sleep time (TST) submitted to chronic sleep restriction. Participants in this study will be 30 male volunteers, aged between 20 and 35 years, divided into three groups: Group 1 (n = 10) with TST ≤ 6 hours (h), Group 2 (n = 10) with TST ≥ 9h and Group 3 (n = 10): TST with between 7 and 8h. The TST will be established by the constant and continuous use of actigraphy for 10 days prior to the onset of the experimental protocol. All volunteers will undergo medical and polysomnography (PSG) examination to detect the presence or not of changes in sleep as well as other health problem that prevents their participation in the study. The experimental protocol consists of a basal night of sleep, five consecutive nights of chronic sleep restriction to 25% of TST in the beginning night and a night of recovery, which will be allowed to sleep the sleep pattern. Each night will have PSG monitoring and when wake up in each day, the volunteer will undergo tests to assess the physiological and neurobehavioral variables. The significance level will be 5% (p ≤ 0.05).

Study Overview

Study Type

Observational

Enrollment (Actual)

20

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

    • SP
      • Sao Paulo, SP, Brazil, 04020-050
        • Federal University of São Paulo

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years to 35 years (Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

Male

Sampling Method

Probability Sample

Study Population

Community sample, residents of Sao Paulo city

Description

Inclusion Criteria:

  • Body Mass Index ≤ 25 kg/m2
  • Physically active individuals
  • 8 years of school education.

Exclusion Criteria:

  • High level of anxiety - State-Trait Anxiety Inventory (STAI-T) ≥ 35
  • High level of anxiety - Beck Depression Inventory ≥ 19
  • PSQI - Pittsburgh Sleep Quality Index ≥ 11
  • ESS - Epworth Sleepiness Scale ≥ 15
  • Irregular rhythm of sleep identified by actigraphy
  • Sleep disturbance by polysomnography
  • Shift worker or nocturnal worker;
  • Obesity;
  • Smoker;
  • Alcohol Intake of more than 3 drinks per day;
  • Taking sleep medications or illicit drugs.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Group 1
Men with Total Sleep Time ≤ 6h that will undergo 25 percent of chronic sleep restriction of their TST
All volunteers will undergo 25% of sleep restriction of their total sleep time at the beginning sleep for five consecutive days. The nights will be monitored by polysomnography.
Other Names:
  • Sleep
  • Chronic
  • Restriction
Group 2
Men with Total Sleep Time (range 7-8h)that will undergo 25 percent of chronic sleep restriction of their TST
All volunteers will undergo 25% of sleep restriction of their total sleep time at the beginning sleep for five consecutive days. The nights will be monitored by polysomnography.
Other Names:
  • Sleep
  • Chronic
  • Restriction
Group 3
Men with Total Sleep Time ≥ 9h that will undergo 25 percent of chronic sleep restriction of their TST
All volunteers will undergo 25% of sleep restriction of their total sleep time at the beginning sleep for five consecutive days. The nights will be monitored by polysomnography.
Other Names:
  • Sleep
  • Chronic
  • Restriction

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

  • Principal Investigator: Marco T De Mello, Ph.D, Federal University of São Paulo
  • Study Chair: Sergio Tufik, Ph.D, Federal University of São Paulo
  • Study Chair: Juliana MS Prado, Ph.D, Federal University of São Paulo
  • Study Chair: Patricia Rzezak, Ph.D, Federal University of São Paulo
  • Study Chair: Sandra S De Queiroz, Federal University of São Paulo

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

December 1, 2011

Primary Completion (Actual)

December 1, 2014

Study Completion (Actual)

February 1, 2015

Study Registration Dates

First Submitted

December 14, 2011

First Submitted That Met QC Criteria

December 15, 2011

First Posted (Estimate)

December 16, 2011

Study Record Updates

Last Update Posted (Estimate)

February 3, 2016

Last Update Submitted That Met QC Criteria

February 2, 2016

Last Verified

February 1, 2016

More Information

Terms related to this study

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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