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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. The completion date has passed and the status has not been verified in more than two years.
Verified March 2012 by Marco Tulio de Mello, Federal University of São Paulo.
Recruitment status was:  Recruiting
Sponsor:
ClinicalTrials.gov Identifier:
NCT01562262
First Posted: March 23, 2012
Last Update Posted: March 27, 2012
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Marco Tulio de Mello, Federal University of São Paulo
  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

Resource links provided by NLM:


Further study details as provided by Marco Tulio de Mello, Federal University of São Paulo:

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

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   20 Years to 45 Years   (Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
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
Criteria

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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01562262


Contacts
Contact: Amaury T Barreto, Bsc 551155720177 pesquisa.apneia@gmail.com

Locations
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         
Sponsors and Collaborators
Federal University of São Paulo
  More Information

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
First Submitted: March 21, 2012
First Posted: March 23, 2012
Last Update Posted: March 27, 2012
Last Verified: March 2012

Keywords provided by Marco Tulio de Mello, Federal University of São Paulo:
Apnea
PVT
Reaction Time

Additional relevant MeSH terms:
Apnea
Sleep Apnea Syndromes
Respiration Disorders
Respiratory Tract Diseases
Signs and Symptoms, Respiratory
Signs and Symptoms
Sleep Disorders, Intrinsic
Dyssomnias
Sleep Wake Disorders
Nervous System Diseases