Comparison of RT in Patients With Sleep Apnea With and Without Complaints of Daytime Sleepiness

NCT01562262 | Unknown DMC

• 1 other identifier: CEP1122/11
• Study Type: observational
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

Not all patients with the Obstructive Sleep Apnea Syndrome (OSAS), mostly mild, have excessive daytime sleepiness. Sleep fragmentation provides the performance decrease with increasing reaction time to external stimuli and correlates with excessive sleepiness. So, the study aims at assessing the effect of sleep fragmentation on the Reaction Time and it's maintenance in patients with OSAS compared with healthy, to better clarify were patients with and without somnolence differ. For that, will be recruited 30 male volunteers aged between 20 and 50 year old to participate in the study. They will be distributed in three groups: "CONTROL" (without symptoms of sleepiness and apnea and hypopnea index (AHI) less than 5), "SS" (with AHI between 5 and 15 without symptoms of somnolence) and group "CS" (with AHI between 5 and 15 with symptoms of somnolence). The groups will undergo a polysomnography and subsequently, the Test and Maintenance of Wakefulness and PVT Battery Tests. The reaction time will be compared, as well as the ability to keep the reaction time over time between groups to see whether there is a difference between the motor performance throughout the day and the perception of sleepiness.

Conditions

Sleep Apnea

Keywords

Apnea; PVT; Reaction Time

Study Arms (3)

CTR

Control group

ASS

Apnea without complaints group

ACS

SAOS Group

Eligibility Criteria

• Age: 20 Years - 45 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

Man, ages between 20 and 45 years with and without drowsiness and no sleep disturbances checked before the study

You may qualify if:

• Man
• Aged between 20 and 45 years old
• BMI between 20-30

You may not qualify if:

• Cigarette Smoke
• Drug intake
• Other sleep disturbances

Sponsors & Collaborators

• Federal University of São Paulo: lead

Study Sites (1)

Federal University of São Paulo

São Paulo, São Paulo, 04020-060, Brazil

RECRUITING

MeSH Terms

Conditions

Sleep Apnea Syndromes; Apnea

Condition Hierarchy (Ancestors)

Respiration Disorders; Respiratory Tract Diseases; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Nervous System Diseases; Signs and Symptoms, Respiratory; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Central Study Contacts

Amaury T Barreto, Bsc

CONTACT

551155720177; pesquisa.apneia@gmail.com

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: PhD Professor

Study Record Dates

• First Submitted: March 21, 2012
• First Posted: March 23, 2012
• Study Start: October 1, 2011
• Primary Completion: March 1, 2012
• Study Completion: March 1, 2013
• Last Updated: March 27, 2012

Record last verified: 2012-03

Locations

BR (1)