Chronic Sleep Restriction

Completed

• Conditions: Other Conditions That May Be A Focus of Clinical Attention
• Interventions: Other: Chronic Sleep Restriction

• Registration Number: NCT01493661
• Lead Sponsor: Federal University of São Paulo

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).

Detailed Description

Not available

Study Timeline

• Study Start: 2011-12
• Study First Submitted: 2011-12-14
• Study First Submitted QC: 2011-12-15
• Study First Posted: 2011-12-16
• Primary Completion: 2014-12
• Study Completion: 2015-02
• Status Verified: 2016-02
• Last Update Submitted: 2016-02-02
• Last Update Posted: 2016-02-03

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 20

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

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Group 1	Chronic Sleep Restriction	Men with Total Sleep Time ≤ 6h that will undergo 25 percent of chronic sleep restriction of their TST
Group 2	Chronic Sleep Restriction	Men with Total Sleep Time (range 7-8h)that will undergo 25 percent of chronic sleep restriction of their TST
Group 3	Chronic Sleep Restriction	Men with Total Sleep Time ≥ 9h that will undergo 25 percent of chronic sleep restriction of their TST

Trial Locations

Locations (1)

Federal University of Sao Paulo; 🇧🇷 Sao Paulo, SP, Brazil