Clinical trial NCT01884454: SLEEP AND OSA ON REPRODUCTIVE FUNCTION IN MEN
Official title: EFFECTS OF SLEEP LOSS AND OBSTRUCTIVE SLEEP APNEA SYNDROME ON REPRODUCTIVE FUNCTION IN MEN
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Obstructive Sleep Apnea
Keywords: sleep
obstructive sleep apnea
reproduction
sperm
hormones
men
Lead sponsor: Federal University of São Paulo
Sponsor class: OTHER
First posted: 2013-06-24
Enrollment: 60
Sex: MALE
Minimum age (years): 25
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: 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

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.

Eligibility criteria: 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

Primary outcomes:
measure: Change in sperm analysis
timeFrame: 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 outcomes:
measure: change hormonal evaluation
timeFrame: change from baseline, sleep deprivations and rebound period. Participants will be followed for the duration of laboratory stay, an expected average of 7 days
Other outcomes:
measure: Sleep patterns of the study population
timeFrame: Change from baseline, sleep deprivations and rebound period. Participants will be followed for the duration of laboratory stay, an expected average of 7 days
measure: Change gene expression
timeFrame: Change from baseline, sleep deprivations and rebound period. Participants will be followed for the duration of laboratory stay, an expected average of 7 days
Locations:
city: Sao Paulo
country: Brazil
facility: Universidade Federal de Sao Paulo
Study officials:
affiliation: Federal University of São Paulo
name: Tathiana A Alvarenga, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Federal University of São Paulo
name: Monica L Andersen, Prof
role: STUDY_DIRECTOR
References: