SLEEP AND OSA ON REPRODUCTIVE FUNCTION IN MEN

Completed

• Conditions: Obstructive Sleep Apnea
• Interventions: Behavioral: Sleep deprivation

• Registration Number: NCT01884454
• Lead Sponsor: Federal University of São Paulo

Brief Summary

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

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.

Study Timeline

• Study Start: 2013-06
• Study First Submitted: 2013-06-18
• Study First Submitted QC: 2013-06-20
• Study First Posted: 2013-06-24
• Primary Completion: 2013-11
• Study Completion: 2014-09
• Status Verified: 2016-02
• Last Update Submitted: 2016-02-02
• Last Update Posted: 2016-02-03

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 60

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Total sleep deprivation	Sleep deprivation	Healthy volunteers will be submitted to total sleep deprivation (TSD) for 48 hours.
REM sleep deprivation	Sleep deprivation	Healthy volunteers will be submitted to selective REM sleep deprivation (REMSD) for 48 hours.

Primary Outcome Measures

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

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Universidade Federal de Sao Paulo; 🇧🇷 Sao Paulo, Brazil