Clinical Trials Directory

Trials / Completed

CompletedNCT01884454

SLEEP AND OSA ON REPRODUCTIVE FUNCTION IN MEN

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

Status
Completed
Phase
Study type
Observational
Enrollment
60 (actual)
Sponsor
Federal University of São Paulo · Academic / Other
Sex
Male
Age
25 Years – 50 Years
Healthy volunteers
Accepted

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.

Conditions

Interventions

TypeNameDescription
BEHAVIORALSleep deprivationVolunteers 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).

Timeline

Start date
2013-06-01
Primary completion
2013-11-01
Completion
2014-09-01
First posted
2013-06-24
Last updated
2016-02-03

Locations

1 site across 1 country: Brazil

Source: ClinicalTrials.gov record NCT01884454. Inclusion in this directory is not an endorsement.