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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified March 2012 by Federal University of São Paulo.
Recruitment status was  Recruiting
Sponsor:
Information provided by (Responsible Party):
Marco Tulio de Mello, Federal University of São Paulo
ClinicalTrials.gov Identifier:
NCT01562262
First received: March 21, 2012
Last updated: March 24, 2012
Last verified: March 2012

March 21, 2012
March 24, 2012
October 2011
March 2012   (final data collection date for primary outcome measure)
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Complete list of historical versions of study NCT01562262 on ClinicalTrials.gov Archive Site
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Comparison of RT in Patients With Sleep Apnea With and Without Complaints of Daytime Sleepiness
Behavior of Psychomotor Vigilance Task Performance in Subjects With Obstructive Sleep Apnea With and Without Complaints of Daytime Sleepiness

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.

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Observational
Observational Model: Case Control
Time Perspective: Cross-Sectional
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Non-Probability Sample

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

Sleep Apnea
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  • CTR
    Control group
  • ASS
    Apnea without complaints group
  • ACS
    SAOS Group
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
30
March 2013
March 2012   (final data collection date for primary outcome measure)

Inclusion Criteria:

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

Exclusion Criteria:

  • Cigarette Smoke
  • Drug intake
  • Other sleep disturbances
Male
20 Years to 45 Years
Yes
Contact: Amaury T Barreto, Bsc 551155720177 pesquisa.apneia@gmail.com
Brazil
 
NCT01562262
CEP1122/11
Yes
Marco Tulio de Mello, Federal University of São Paulo
Federal University of São Paulo
Not Provided
Not Provided
Federal University of São Paulo
March 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP