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Chronic Sleep Restriction (CSR)

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ClinicalTrials.gov Identifier: NCT01493661
Recruitment Status : Completed
First Posted : December 16, 2011
Last Update Posted : February 3, 2016
Sponsor:
Collaborators:
Associação Fundo de Incentivo à Pesquisa
Fundação de Amparo à Pesquisa do Estado de São Paulo
Information provided by (Responsible Party):
Marco Tulio de Mello, Federal University of São Paulo

December 14, 2011
December 16, 2011
February 3, 2016
December 2011
December 2014   (Final data collection date for primary outcome measure)
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Complete list of historical versions of study NCT01493661 on ClinicalTrials.gov Archive Site
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Chronic Sleep Restriction
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).
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Observational
Time Perspective: Cross-Sectional
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Probability Sample
Community sample, residents of Sao Paulo city
Other Conditions That May Be A Focus of Clinical Attention
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:
  • Chronic
  • Sleep
  • Restriction
  • Group 1
    Men with Total Sleep Time ≤ 6h that will undergo 25 percent of chronic sleep restriction of their TST
    Intervention: Other: Chronic Sleep Restriction
  • Group 2
    Men with Total Sleep Time (range 7-8h)that will undergo 25 percent of chronic sleep restriction of their TST
    Intervention: Other: Chronic Sleep Restriction
  • Group 3
    Men with Total Sleep Time ≥ 9h that will undergo 25 percent of chronic sleep restriction of their TST
    Intervention: Other: Chronic Sleep Restriction
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
20
30
February 2015
December 2014   (Final data collection date for primary outcome measure)

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.
Sexes Eligible for Study: Male
20 Years to 35 Years   (Adult)
Yes
Contact information is only displayed when the study is recruiting subjects
Brazil
 
 
NCT01493661
CEPE2011SSQueiroz
Yes
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Marco Tulio de Mello, Federal University of São Paulo
Federal University of São Paulo
  • Associação Fundo de Incentivo à Pesquisa
  • Fundação de Amparo à Pesquisa do Estado de São Paulo
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
Federal University of São Paulo
February 2016