SLEEP AND OSA ON REPRODUCTIVE FUNCTION IN MEN

NCT ID: NCT01884454

Last Updated: 2016-02-03

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

COMPLETED

Total Enrollment

60 participants

Study Classification

OBSERVATIONAL

Study Start Date

2013-06-30

Study Completion Date

2014-09-30

Brief Summary

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In view of the hormonal changes induced by both sleep deprivation and obstructive sleep apnea syndrome (OSA), and the importance of maintaining these hormones in reproductive processes. The present study aims to evaluate the effects of the OSA or sleep deprivation (total or selective REM sleep for 48h) on reproductive function in adult men with normal body mass index.

Detailed Description

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In this study will be recruited volunteers 25-50 years of age with a body mass index (BMI) 20-25 kg/m2 (normal) that after performing polysomnography, will be distributed in the following groups: healthy or diagnosed with obstructive sleep apnea syndrome (OSA). Volunteers without OSA 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). Blood samples will be taken for hormonal analysis (testosterone, luteinizing hormone, follicle-stimulating hormone, progesterone and cortisol)and gene expression. The semen collection for evaluation of sperm count (concentration, viability and sperm morphology) in three different periods, baseline collection, after SD protocols and the end of rebound period. Individuals diagnosed with OSA also have three collections of blood and semen samples for analyzes.

Conditions

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Obstructive Sleep Apnea

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

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

Intervention Type BEHAVIORAL

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

Intervention Type BEHAVIORAL

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).

Intervention Type BEHAVIORAL

Other Intervention Names

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Total sleep deprivation REM sleep deprivation

Eligibility Criteria

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Inclusion Criteria

* men
* 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

* smokers
* 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
Minimum Eligible Age

25 Years

Maximum Eligible Age

50 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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Monica Levy Andersen

Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

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

Site Status

Countries

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Brazil

Related Links

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http://www.aasmnet.org/

American Academy of Sleep Medicine

Other Identifiers

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PSAR01

Identifier Type: -

Identifier Source: org_study_id

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