Comparison of RT in Patients With Sleep Apnea With and Without Complaints of Daytime Sleepiness
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Purpose
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.
| Condition |
|---|
|
Sleep Apnea |
| Study Type: | Observational |
| Study Design: | Observational Model: Case Control Time Perspective: Cross-Sectional |
| Official Title: | Behavior of Psychomotor Vigilance Task Performance in Subjects With Obstructive Sleep Apnea With and Without Complaints of Daytime Sleepiness |
| Estimated Enrollment: | 30 |
| Study Start Date: | October 2011 |
| Estimated Study Completion Date: | March 2013 |
| Primary Completion Date: | March 2012 (Final data collection date for primary outcome measure) |
| Groups/Cohorts |
|---|
|
CTR
Control group
|
|
ASS
Apnea without complaints group
|
|
ACS
SAOS Group
|
Eligibility| Ages Eligible for Study: | 20 Years to 45 Years |
| Genders Eligible for Study: | Male |
| Accepts Healthy Volunteers: | Yes |
| Sampling Method: | Non-Probability Sample |
Man, ages between 20 and 45 years with and without drowsiness and no sleep disturbances checked before the study
Inclusion Criteria:
- Man
- Aged between 20 and 45 years old
- BMI between 20-30
Exclusion Criteria:
- Cigarette Smoke
- Drug intake
- Other sleep disturbances
Contacts and Locations| Contact: Amaury T Barreto, Bsc | 551155720177 | pesquisa.apneia@gmail.com |
| Brazil | |
| Federal University of São Paulo | Recruiting |
| São Paulo, SP, Brazil, 04020-060 | |
| Contact: Gloria Silva, Secretariat 551155720177 gloria@cepebr.org | |
| Principal Investigator: Marco Tulio de Mello, PhD | |
More Information
No publications provided
| Responsible Party: | Marco Tulio de Mello, PhD Professor, Federal University of São Paulo |
| ClinicalTrials.gov Identifier: | NCT01562262 History of Changes |
| Other Study ID Numbers: | CEP1122/11 |
| Study First Received: | March 21, 2012 |
| Last Updated: | March 24, 2012 |
| Health Authority: | Brazil: National Committee of Ethics in Research |
Keywords provided by Federal University of São Paulo:
|
Apnea PVT Reaction Time |
Additional relevant MeSH terms:
|
Apnea Sleep Apnea Syndromes Sleep Apnea, Obstructive Respiration Disorders Respiratory Tract Diseases Signs and Symptoms, Respiratory |
Signs and Symptoms Sleep Disorders, Intrinsic Dyssomnias Sleep Disorders Nervous System Diseases |
ClinicalTrials.gov processed this record on May 19, 2013