Study Results
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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COMPLETED
60 participants
OBSERVATIONAL
2013-06-30
2014-09-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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CASE_CONTROL
CROSS_SECTIONAL
Study Groups
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Total sleep deprivation
Healthy volunteers will be submitted to total sleep deprivation (TSD) for 48 hours.
Sleep deprivation
Volunteers will be submitted to total sleep deprivation (SD) or selective REM sleep deprivation for 48 hours. After SD, these volunteers will be allowed to sleep for 48 hours (period rebound).
moderate to severe OSA
Patients diagnosed with moderate to severe obstructive sleep apnea syndrome (OSA) with normal or overweight body mass index (BMI), will be recruited.
No interventions assigned to this group
REM sleep deprivation
Healthy volunteers will be submitted to selective REM sleep deprivation (REMSD) for 48 hours.
Sleep deprivation
Volunteers will be submitted to total sleep deprivation (SD) or selective REM sleep deprivation for 48 hours. After SD, these volunteers will be allowed to sleep for 48 hours (period rebound).
Control
The control group will be subjects with an apnea hypopnea index \<5/h.
No interventions assigned to this group
Interventions
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Sleep deprivation
Volunteers will be submitted to total sleep deprivation (SD) or selective REM sleep deprivation for 48 hours. After SD, these volunteers will be allowed to sleep for 48 hours (period rebound).
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* There is no discrimination of economic class
* Age between 25 and 50
* BMI 30 kg/m2
* No prior neurological, psychiatric or use of psychotropic medication
* OSA (moderate and severe apnea hypopnea index \> 15)
Exclusion Criteria
* addiction
* Individuals with another sleep disorder
* Severe uncontrolled organic disease that might interfere with the conduct of the study, such as cancer, heart disease, digestive disorders, diabetes mellitus, male reproductive system
* Presence of moderate or severe depression and psychiatric disorders
* Volunteers with previous treatment for OSA
25 Years
50 Years
MALE
Yes
Sponsors
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Federal University of São Paulo
OTHER
Responsible Party
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Monica Levy Andersen
Professor
Principal Investigators
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Tathiana A Alvarenga, PhD
Role: PRINCIPAL_INVESTIGATOR
Federal University of São Paulo
Monica L Andersen, Prof
Role: STUDY_DIRECTOR
Federal University of São Paulo
Locations
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Universidade Federal de Sao Paulo
São Paulo, São Paulo, Brazil
Countries
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Related Links
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American Academy of Sleep Medicine
Other Identifiers
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PSAR01
Identifier Type: -
Identifier Source: org_study_id
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