SLEEP AND OSA ON REPRODUCTIVE FUNCTION IN MEN (PSAR01)

Federal University of São Paulo

Status: Completed

Conditions: Obstructive Sleep Apnea

Treatments: Behavioral: Sleep deprivation

Study type: Observational

Funder types: Other

Identifiers

NCT01884454

PSAR01

Details and patient eligibility

About

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.

Full 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.

Enrollment: 60 patients

Sex: Male

Ages: 25 to 50 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

60 participants in 4 patient groups

Total sleep deprivation

Description:

Healthy volunteers will be submitted to total sleep deprivation (TSD) for 48 hours.

Treatment:

Behavioral: Sleep deprivation

moderate to severe OSA

Description:

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

Description:

Healthy volunteers will be submitted to selective REM sleep deprivation (REMSD) for 48 hours.

Treatment:

Behavioral: Sleep deprivation

Control

Description:

The control group will be subjects with an apnea hypopnea index \<5/h.