Chronic Sleep Restriction

NCT01493661 | Completed DMC

• 1 other identifier: CEPE2011SSQueiroz
• Study Type: observational
• Target: 20
• Locations: 1 country
• Sites: 1

Brief Summary

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).

Conditions

Other Conditions That May Be A Focus of Clinical Attention

Keywords

Sleep; Polysomnography; Reaction Time; Sleep Deprivation; Psychophysiology; Chronic sleep restriction; healthy; without sleep complaints

Study Arms (3)

Group 1

Men with Total Sleep Time ≤ 6h that will undergo 25 percent of chronic sleep restriction of their TST

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

Other: 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

Interventions

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.

Also known as: Chronic, Sleep, Restriction

Group 1; Group 2; Group 3

Eligibility Criteria

• Age: 20 Years - 35 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)
• Sampling Method: Probability Sample

Study Population

Community sample, residents of Sao Paulo city

You may qualify if:

• Body Mass Index ≤ 25 kg/m2
• Physically active individuals
• years of school education.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Federal University of São Paulo: lead
• Associação Fundo de Incentivo à Pesquisa: collaborator
• Fundação de Amparo à Pesquisa do Estado de São Paulo: collaborator

Study Sites (1)

Federal University of Sao Paulo

São Paulo, São Paulo, 04020-050, Brazil

Location

Related Links

• Fundação de Amparo à Pesquisa do Estado de São Paulo

MeSH Terms

Conditions

Sleep Deprivation

Interventions

Sleep

Condition Hierarchy (Ancestors)

Dyssomnias; Sleep Wake Disorders; Nervous System Diseases; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Mental Disorders

Intervention Hierarchy (Ancestors)

Nervous System Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena

Study Officials

• Marco T De Mello, Ph.D

  Federal University of São Paulo

  PRINCIPAL INVESTIGATOR

• 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

  STUDY CHAIR

Study Design

• Study Type: observational
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Ph.D

Study Record Dates

• First Submitted: December 14, 2011
• First Posted: December 16, 2011
• Study Start: December 1, 2011
• Primary Completion: December 1, 2014
• Study Completion: February 1, 2015
• Last Updated: February 3, 2016

Record last verified: 2016-02

Locations

BR (1)