Chronic Sleep Restriction (CSR)
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Purpose
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).
| Condition | Intervention |
|---|---|
|
Other Conditions That May Be A Focus of Clinical Attention |
Other: Chronic Sleep Restriction |
| Study Type: | Observational |
| Study Design: | Time Perspective: Cross-Sectional |
| Official Title: | Chronic Sleep Restriction: Neurobehavioral and Physiological Responses |
| Estimated Enrollment: | 30 |
| Study Start Date: | December 2011 |
| Groups/Cohorts | Assigned Interventions |
|---|---|
|
Group 1
Men with Total Sleep Time ≤ 6h that will undergo 25 percent of chronic sleep restriction of their TST
|
Other: Chronic Sleep Restriction
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
|
Other: Chronic Sleep Restriction
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
|
Other: Chronic Sleep Restriction
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:
|
Eligibility| Ages Eligible for Study: | 20 Years to 35 Years |
| Genders Eligible for Study: | Male |
| Accepts Healthy Volunteers: | Yes |
| Sampling Method: | Probability Sample |
Community sample, residents of Sao Paulo city
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.
Contacts and Locations| Contact: Marco T de Mello, Ph.D | +55 11 5572-0177 | tmello@demello.net.br |
| Contact: Sandra S Queiroz | +55 11 5572-0177 | sqsandra@cepebr.org |
| Brazil | |
| Federal University of Sao Paulo | Recruiting |
| Sao Paulo, SP, Brazil, 04020-050 | |
| Contact: Sandra S De Queiroz +55 11 5572-0177 sqsandra@cepebr.org | |
| Principal Investigator: Marco T de Mello, Ph.D | |
| Sub-Investigator: Juliana M da Silva Prado, Ph.D | |
| Sub-Investigator: Patrícia Rzezak, Ph.D | |
| Sub-Investigator: Sergio Tufik, Ph.D | |
| Sub-Investigator: Sandra S De Queiroz | |
| Principal Investigator: | Marco T De Mello, 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: | Sergio Tufik, Ph.D | Federal University of São Paulo |
| Study Chair: | Sandra S De Queiroz | Federal University of São Paulo |
More Information
Additional Information:
No publications provided
| Responsible Party: | Marco Tulio de Mello, Ph.D, Federal University of São Paulo |
| ClinicalTrials.gov Identifier: | NCT01493661 History of Changes |
| Other Study ID Numbers: | CEPE2011SSQueiroz |
| Study First Received: | December 14, 2011 |
| Last Updated: | January 10, 2012 |
| Health Authority: | Brazil: Ethics Committee |
Keywords provided by Federal University of São Paulo:
|
Sleep Polysomnography Reaction Time Sleep Deprivation |
Psychophysiology Chronic sleep restriction healthy without sleep complaints |
ClinicalTrials.gov processed this record on May 23, 2013