SLEEP AND OSA ON REPRODUCTIVE FUNCTION IN MEN

Study Overview
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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.

Official Title
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EFFECTS OF SLEEP LOSS AND OBSTRUCTIVE SLEEP APNEA SYNDROME ON REPRODUCTIVE FUNCTION IN MEN

Conditions
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Obstructive Sleep Apnea

Intervention / Treatment
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* Behavioral: Sleep deprivation


Participation Criteria
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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

Ages Eligible for Study
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Minimum Age: 25 Years
Maximum Age: 50 Years

Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Total sleep deprivation<br>Healthy volunteers will be submitted to total sleep deprivation (TSD) for 48 hours. | Behavioral: Sleep deprivation<br>* 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).<br>* Other names: REM sleep deprivation;|
| moderate to severe OSA<br>Patients diagnosed with moderate to severe obstructive sleep apnea syndrome (OSA) with normal or overweight body mass index (BMI), will be recruited. | |
| REM sleep deprivation<br>Healthy volunteers will be submitted to selective REM sleep deprivation (REMSD) for 48 hours. | Behavioral: Sleep deprivation<br>* 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).<br>* Other names: REM sleep deprivation;|
| Control<br>The control group will be subjects with an apnea hypopnea index <5/h. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in sperm analysis | - Semen collection (concentration, viability and sperm morphology) | change from baseline, sleep deprivations and rebound period. Participants will be followed for the duration of laboratory stay, an expected average of 7 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| change hormonal evaluation | - Hormonal analysis (testosterone, luteinizing hormone, follicle-stimulating hormone, progesterone and cortisol) | change from baseline, sleep deprivations and rebound period. Participants will be followed for the duration of laboratory stay, an expected average of 7 days | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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sleep, obstructive sleep apnea, reproduction, sperm, hormones, men