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Completed

NCT Number: NCT01493661

Chronic Sleep Restriction

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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Key information

Age range

20 year–35 year

Sex eligibility

Male

Study type

Observational

Primary location

Federal University of Sao Paulo

São Paulo, 04020-050, Brazil

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Chronic Sleep Restriction

Other

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

Sponsors and collaborators

Lead sponsor

Federal University of São Paulo

Other

Collaborators

  • Associação Fundo de Incentivo à Pesquisa
  • Fundação de Amparo à Pesquisa do Estado de São Paulo

Registry information

Official study title

Chronic Sleep Restriction: Neurobehavioral and Physiological Responses

Acronym: CSR

Important dates

Study start
2011
Primary completion
2014
Study completion
2015
First posted
Dec 16, 2011
Registry last updated
Feb 3, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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