Clinical trial NCT01493661: Chronic Sleep Restriction
Official title: Chronic Sleep Restriction: Neurobehavioral and Physiological Responses
Study type: OBSERVATIONAL
Overall status: COMPLETED
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
Lead sponsor: Federal University of São Paulo
Sponsor class: OTHER
Collaborators: name: Associação Fundo de Incentivo à Pesquisa
name: Fundação de Amparo à Pesquisa do Estado de São Paulo
First posted: 2011-12-16
Enrollment: 20
Sex: MALE
Minimum age (years): 20
Maximum age (years): 35
Standard ages: ADULT
Accepts healthy volunteers: yes
Time perspective: CROSS_SECTIONAL
Sampling method: PROBABILITY_SAMPLE
Study population: Community sample, residents of Sao Paulo city

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).


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.

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Sao Paulo
country: Brazil
facility: Federal University of Sao Paulo
state: SP
Study officials:
affiliation: Federal University of São Paulo
name: Marco T De Mello, Ph.D
role: PRINCIPAL_INVESTIGATOR
affiliation: Federal University of São Paulo
name: Juliana MS Prado, Ph.D
role: STUDY_CHAIR
affiliation: Federal University of São Paulo
name: Patricia Rzezak, Ph.D
role: STUDY_CHAIR
affiliation: Federal University of São Paulo
name: Sergio Tufik, Ph.D
role: STUDY_CHAIR
affiliation: Federal University of São Paulo
name: Sandra S De Queiroz
role: STUDY_CHAIR
References: