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

NCT ID: NCT01562262

Last Updated: 2012-03-27

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

30 participants

Study Classification

OBSERVATIONAL

Study Start Date

2011-10-31

Study Completion Date

2013-03-31

Brief Summary

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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.

Detailed Description

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Conditions

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Sleep Apnea

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

CROSS_SECTIONAL

Study Groups

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CTR

Control group

No interventions assigned to this group

ASS

Apnea without complaints group

No interventions assigned to this group

ACS

SAOS Group

No interventions assigned to this group

Eligibility Criteria

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Inclusion Criteria

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

Exclusion Criteria

* Cigarette Smoke
* Drug intake
* Other sleep disturbances
Minimum Eligible Age

20 Years

Maximum Eligible Age

45 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

Yes

Sponsors

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Federal University of São Paulo

OTHER

Sponsor Role lead

Responsible Party

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Marco Tulio de Mello

PhD Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Federal University of São Paulo

São Paulo, São Paulo, Brazil

Site Status RECRUITING

Countries

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Brazil

Central Contacts

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Amaury T Barreto, Bsc

Role: CONTACT

551155720177

Facility Contacts

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Gloria Silva, Secretariat

Role: primary

551155720177

Other Identifiers

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CEP1122/11

Identifier Type: -

Identifier Source: org_study_id

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