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

Sleep Apnea Clinical Trial

Official title:

Behavior of Psychomotor Vigilance Task Performance in Subjects With Obstructive Sleep Apnea With and Without Complaints of Daytime Sleepiness

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01562262
• Other study ID #: CEP1122/11
• Status: Recruiting
• Phase: N/A
• First received: March 21, 2012
• Last updated: March 24, 2012
• Start date: October 2011
• Est. completion date: March 2013

Study information

• Verified date: March 2012
• Source: Federal University of São Paulo
• Contact: Amaury T Barreto, Bsc
• Phone: 551155720177
• Email: pesquisa.apneia[@]gmail.com
• Is FDA regulated: No
• Health authority: Brazil: National Committee of Ethics in Research
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 30
• Est. completion date: March 2013
• Est. primary completion date: March 2012
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 20 Years to 45 Years

Eligibility

Inclusion Criteria:

• Man

• Aged between 20 and 45 years old

• BMI between 20-30

Exclusion Criteria:

• Cigarette Smoke

• Drug intake

• Other sleep disturbances

Study Design

Observational Model: Case Control, Time Perspective: Cross-Sectional

Related Conditions & MeSH terms

• Apnea
• Sleep Apnea
• Sleep Apnea Syndromes

Locations

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

Sponsors (1)

Lead Sponsor	Collaborator
Federal University of São Paulo

Country where clinical trial is conducted

Brazil,