Comparison of RT in Patients With Sleep Apnea With and Without Complaints of Daytime Sleepiness
| Tracking Information | |||||
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| First Received Date ICMJE | March 21, 2012 | ||||
| Last Updated Date | March 24, 2012 | ||||
| Start Date ICMJE | October 2011 | ||||
| Primary Completion Date | March 2012 (final data collection date for primary outcome measure) | ||||
| Current Primary Outcome Measures ICMJE | Not Provided | ||||
| Original Primary Outcome Measures ICMJE | Not Provided | ||||
| Change History | Complete list of historical versions of study NCT01562262 on ClinicalTrials.gov Archive Site | ||||
| Current Secondary Outcome Measures ICMJE | Not Provided | ||||
| Original Secondary Outcome Measures ICMJE | Not Provided | ||||
| Current Other Outcome Measures ICMJE | Not Provided | ||||
| Original Other Outcome Measures ICMJE | Not Provided | ||||
| Descriptive Information | |||||
| Brief Title ICMJE | Comparison of RT in Patients With Sleep Apnea With and Without Complaints of Daytime Sleepiness | ||||
| Official Title ICMJE | Behavior of Psychomotor Vigilance Task Performance in Subjects With Obstructive Sleep Apnea With and Without Complaints of Daytime Sleepiness | ||||
| 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. |
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| Detailed Description | Not Provided | ||||
| Study Type ICMJE | Observational | ||||
| Study Design ICMJE | Observational Model: Case Control Time Perspective: Cross-Sectional |
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| Target Follow-Up Duration | Not Provided | ||||
| Biospecimen | Not Provided | ||||
| 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 |
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| Condition ICMJE | Sleep Apnea | ||||
| Intervention ICMJE | Not Provided | ||||
| Study Group/Cohort (s) |
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| Publications * | Not Provided | ||||
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |||||
| Recruitment Status ICMJE | Recruiting | ||||
| Estimated Enrollment ICMJE | 30 | ||||
| Estimated Completion Date | March 2013 | ||||
| Primary Completion Date | March 2012 (final data collection date for primary outcome measure) | ||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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| Gender | Male | ||||
| Ages | 20 Years to 45 Years | ||||
| Accepts Healthy Volunteers | Yes | ||||
| Contacts ICMJE |
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| Location Countries ICMJE | Brazil | ||||
| Administrative Information | |||||
| NCT Number ICMJE | NCT01562262 | ||||
| Other Study ID Numbers ICMJE | CEP1122/11 | ||||
| Has Data Monitoring Committee | Yes | ||||
| Responsible Party | Marco Tulio de Mello, Federal University of São Paulo | ||||
| Study Sponsor ICMJE | Federal University of São Paulo | ||||
| Collaborators ICMJE | Not Provided | ||||
| Investigators ICMJE | Not Provided | ||||
| Information Provided By | Federal University of São Paulo | ||||
| Verification Date | March 2012 | ||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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