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Chronic Sleep Restriction (CSR)

The recruitment status of this study is unknown because the information has not been verified recently.
Verified January 2012 by Federal University of São Paulo.
Recruitment status was  Recruiting
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
ClinicalTrials.gov Identifier:
NCT01493661
First received: December 14, 2011
Last updated: January 10, 2012
Last verified: January 2012
  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

Further study details as provided by Federal University of São Paulo:

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:
  • 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
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 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:
  • Chronic
  • Sleep
  • Restriction

  Eligibility

Ages Eligible for Study:   20 Years to 35 Years
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
Sampling Method:   Probability Sample
Study Population

Community sample, residents of Sao Paulo city

Criteria

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01493661

Contacts
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

Locations
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         
Sponsors and Collaborators
Federal University of São Paulo
Associação Fundo de Incentivo à Pesquisa
Fundação de Amparo à Pesquisa do Estado de São Paulo
Investigators
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 November 25, 2014