Chronic Sleep Restriction

Other Conditions That May Be A Focus of Clinical Attention Clinical Trial

— CSR  

Official title:

Chronic Sleep Restriction: Neurobehavioral and Physiological Responses

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01493661
• Other study ID #: CEPE2011SSQueiroz
• Status: Completed
• Phase: N/A
• First received: December 14, 2011
• Last updated: February 2, 2016
• Start date: December 2011
• Est. completion date: February 2015

Study information

• Verified date: February 2016
• Source: Federal University of São Paulo
• Contact: n/a
• Is FDA regulated: No
• Health authority: Brazil: Ethics Committee
• Study type: Observational

Clinical Trial 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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 20
• Est. completion date: February 2015
• Est. primary completion date: December 2014
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 20 Years to 35 Years

Eligibility

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.

Study Design

Time Perspective: Cross-Sectional

Related Conditions & MeSH terms

• Other Conditions That May Be A Focus of Clinical Attention

Intervention

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.

Locations

Country	Name	City	State
Brazil	Federal University of Sao Paulo	Sao Paulo	SP

Sponsors (3)

Lead Sponsor	Collaborator
Federal University of São Paulo	Associação Fundo de Incentivo à Pesquisa, Fundação de Amparo à Pesquisa do Estado de São Paulo

Country where clinical trial is conducted

Brazil, 

External Links

•   Centro de Estudos em Psicobiologia e Exercício
•   Fundação de Amparo à Pesquisa do Estado de São Paulo
•   Psychobiology department of Federal University of Sao Paulo