- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01493661
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
Status
Completed
Intervention / Treatment
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
-
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SP
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Sao Paulo, SP, Brazil, 04020-050
- Federal University of São Paulo
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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:
|
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:
|
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:
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
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
Keywords
Other Study ID Numbers
- CEPE2011SSQueiroz
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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