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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT01562262
Other study ID # CEP1122/11
Secondary ID
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


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, 

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