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SLEEP AND OSA ON REPRODUCTIVE FUNCTION IN MEN

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

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT01884454
Acronym
PSAR01
Enrollment
60
Registered
2013-06-24
Start date
2013-06-30
Completion date
2014-09-30
Last updated
2016-02-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Obstructive Sleep Apnea

Keywords

sleep, obstructive sleep apnea, reproduction, sperm, hormones, men

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.

Interventions

BEHAVIORALSleep deprivation

Volunteers 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).

Sponsors

Federal University of São Paulo
Lead SponsorOTHER

Study design

Observational model
CASE_CONTROL
Time perspective
CROSS_SECTIONAL

Eligibility

Sex/Gender
MALE
Age
25 Years to 50 Years
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frameDescription
Change in sperm analysischange 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

MeasureTime frameDescription
change hormonal evaluationchange 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)

Other

MeasureTime frameDescription
Sleep patterns of the study populationChange from baseline, sleep deprivations and rebound period. Participants will be followed for the duration of laboratory stay, an expected average of 7 days\- Polysomnography
Change gene expressionChange from baseline, sleep deprivations and rebound period. Participants will be followed for the duration of laboratory stay, an expected average of 7 daysBlood will be collected in specific tubes (PaxGene)for RNA extraction and gene expression determination.

Countries

Brazil

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026