Chronic Sleep Restriction

NCT ID: NCT01493661

Last Updated: 2016-02-03

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 20 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2011-12-31
• Study Completion Date: 2015-02-28

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

Study Design

• Study Time Perspective: CROSS_SECTIONAL

Study Groups

Group 1

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

Chronic Sleep Restriction

Intervention Type: 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.

Group 2

Men with Total Sleep Time (range 7-8h)that will undergo 25 percent of chronic sleep restriction of their TST

Chronic Sleep Restriction

Intervention Type: 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.

Group 3

Men with Total Sleep Time ≥ 9h that will undergo 25 percent of chronic sleep restriction of their TST

Chronic Sleep Restriction

Intervention Type: 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.

Interventions

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.

Intervention Type: OTHER

Other Intervention Names

Chronic; Sleep; Restriction

Eligibility 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.

• Minimum Eligible Age: 20 Years
• Maximum Eligible Age: 35 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: Yes

Sponsors

Associação Fundo de Incentivo à Pesquisa

OTHER

Sponsor Role: collaborator

Fundação de Amparo à Pesquisa do Estado de São Paulo

OTHER_GOV

Sponsor Role: collaborator

Federal University of São Paulo

OTHER

Sponsor Role: lead

Responsible Party

Marco Tulio de Mello

Ph.D

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Marco T De Mello, Ph.D

Role: PRINCIPAL_INVESTIGATOR

Federal University of São Paulo

Juliana MS Prado, Ph.D

Role: STUDY_CHAIR

Federal University of São Paulo

Patricia Rzezak, Ph.D

Role: STUDY_CHAIR

Federal University of São Paulo

Sergio Tufik, Ph.D

Role: STUDY_CHAIR

Federal University of São Paulo

Sandra S De Queiroz

Role: STUDY_CHAIR

Federal University of São Paulo

Locations

Federal University of Sao Paulo

São Paulo, São Paulo, Brazil

Countries

Brazil

Related Links

http://www.fapesp.br/

Fundação de Amparo à Pesquisa do Estado de São Paulo

Other Identifiers

CEPE2011SSQueiroz

Identifier Type: -

Identifier Source: org_study_id