SLEEP AND OSA ON REPRODUCTIVE FUNCTION IN MEN

Obstructive Sleep Apnea Clinical Trial

— PSAR01  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01884454
• Other study ID #: PSAR01
• Status: Completed
• Phase: N/A
• First received: June 18, 2013
• Last updated: February 2, 2016
• Start date: June 2013
• Est. completion date: September 2014

Study information

• Verified date: February 2016
• Source: Federal University of São Paulo
• Contact: n/a
• Is FDA regulated: No
• Health authority: Brazil: Ethics Committee
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: September 2014
• Est. primary completion date: November 2013
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 25 Years to 50 Years

Eligibility

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

Study Design

Observational Model: Case Control, Time Perspective: Cross-Sectional

Related Conditions & MeSH terms

• Obstructive Sleep Apnea
• Sleep Apnea Syndromes
• Sleep Apnea, Obstructive

Intervention

Behavioral:
• Sleep 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).

Locations

Country	Name	City	State
Brazil	Universidade Federal de Sao Paulo	Sao Paulo

Sponsors (1)

Lead Sponsor	Collaborator
Federal University of São Paulo

Country where clinical trial is conducted

Brazil, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Sleep patterns of the study population	- Polysomnography	Change from baseline, sleep deprivations and rebound period. Participants will be followed for the duration of laboratory stay, an expected average of 7 days	Yes
Other	Change gene expression	Blood will be collected in specific tubes (PaxGene)for RNA extraction and gene expression determination.	Change from baseline, sleep deprivations and rebound period. Participants will be followed for the duration of laboratory stay, an expected average of 7 days	Yes
Primary	Change in sperm analysis	- Semen collection (concentration, viability and sperm morphology)	change from baseline, sleep deprivations and rebound period. Participants will be followed for the duration of laboratory stay, an expected average of 7 days	Yes
Secondary	change hormonal evaluation	- Hormonal analysis (testosterone, luteinizing hormone, follicle-stimulating hormone, progesterone and cortisol)	change from baseline, sleep deprivations and rebound period. Participants will be followed for the duration of laboratory stay, an expected average of 7 days	Yes

External Links

•   American Academy of Sleep Medicine