EFFECTS OF SLEEP LOSS AND OBSTRUCTIVE SLEEP APNEA SYNDROME ON REPRODUCTIVE FUNCTION IN MEN
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Change in sperm analysis
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 时间视角
- Cross Sectional
入排标准
- 年龄范围
- 25 Years 至 50 Years（Adult）
- 性别
- Male
- 接受健康志愿者
- 是
入选标准
- •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)
排除标准
- •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
结局指标
主要结局
Change in sperm analysis
时间窗: 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)
次要结局
- 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)
研究者
Monica Levy Andersen
Professor
Federal University of São Paulo