This trial is active, not recruiting.

Conditions sleep apnea, obstructive, sleep apnea, hypotestosteronism
Sponsor Lahey Clinic
Start date January 2009
End date August 2016
Trial size 200 participants
Trial identifier NCT00832065, 2008-066


Obstructive Sleep Apnea Syndrome (OSAS)is a common disease and is suspected to be associated with sexual dysfunction. Our purpose is to sudy the effect of CPAP (Continuous Positive Airway Pressure) treatment on patients' sexual dysfunction by measuring testosterone levels before and after CPAP treatments.

United States No locations recruiting
Other countries No locations recruiting

Study Design

Observational model case-only
Time perspective prospective
Adult male patients between 18-70 years of age with nely diagnosed OSAS documented by all night polysomnography(PSG)

Primary Outcomes

Correlation between low free testosterone levels, sexual dysfunction and Obstructive Sleep Apnea before and after treatment with CPAP. Free testosterone levels and its affect with CPAP treatment
time frame: 3 months

Secondary Outcomes

Sexual Function Assessments. Confirmation of a link between OSAS, elevated CRP levels, and low testosterone.
time frame: 3 months

Eligibility Criteria

Male participants from 18 years up to 70 years old.

Inclusion Criteria: - Adult males ages 18-70 with newly diagnosed OSAS documented by all-night polysomnography (PSG) Exclusion Criteria: - Currently on testosterone replacement therapy - Prior known cause of erectile dysfunction - Patients with prior treatment of erectile dysfunction - Co-morbid conditions like diabetes, hypertension, as well as patient medications, will be recorded, and will not be part of the exclusion criteria

Additional Information

Official title Sexual Dysfunction And Hypotestosteronemia In Patients With Obstructive Sleep Apnea Syndrome And Its Effects With CPAP Therapy
Principal investigator Akmal Sarwar, M.D.
Description Obstructive Sleep Apnea Syndrome(OSAS) is a highly prevalent disease in the population, affecting at least 4% of males and to a lesser extent females, yet it is currently under diagnosed. OSAS is associated with various disorders including cardiovascular disease, insulin resistance, diabetes mellitus, fatigue and erectile dysfunction. Currently the standard treatment for OSAS is Continuous Positive Airway Pressure(CPAP). Low testosterone levels are present in some patients with OSAS leading to erectile dysfunction. However, the true prevalence of low testosterone levels and its correlation with sexual health is poorly understood and undefined. Prior data suggest treating these patients with CPAP therapy, usually increases testosterone levels, but unclear if this makes any meaningful difference in patient outcome, that is improvement in libido and sexual function. There are several postulations to the pathophysiology of low testosterone levels in patients with OSAS. CRP(C-reactive protein), a strong marker of inflammation was shown to be elevated in patients with OSAS. The association between elevated CRP and low testosterone level would support the notion that inflammation plays a primary role in sexual dysfunction in patients with OSAS. The objective of this study is to identify correlation between low free testosterone levels, sexual dysfunction and Obstructive Sleep Apnea before and after treatment with CPAP. Evaluate the role of CRP and inflammation secondary to OSAS in the pathogenesis of sexual dysfunction.
Trial information was received from ClinicalTrials.gov and was last updated in December 2015.
Information provided to ClinicalTrials.gov by Lahey Clinic.