Sexual Dysfunction And Hypotestosteronemia In Patients With Obstructive Sleep Apnea Syndrome
Sleep Apnea, Obstructive
|Study Design:||Observational Model: Case-Only
Time Perspective: Prospective
|Official Title:||Sexual Dysfunction And Hypotestosteronemia In Patients With Obstructive Sleep Apnea Syndrome And Its Effects With CPAP Therapy|
- 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 ] [ Designated as safety issue: No ]
- Sexual Function Assessments. Confirmation of a link between OSAS, elevated CRP levels, and low testosterone. [ Time Frame: 3 months ] [ Designated as safety issue: No ]
|Study Start Date:||January 2009|
|Estimated Study Completion Date:||December 2016|
|Estimated Primary Completion Date:||August 2016 (Final data collection date for primary outcome measure)|
Patients With Sleep Apnea and Low Testosterone
Adult male patients between 18-70 years of age with nely diagnosed OSAS documented by all night polysomnography(PSG)
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00832065
|United States, Massachusetts|
|Lahey Clinic, Inc.|
|Burlington, Massachusetts, United States, 01805|
|Lahey Clinic Northshore|
|Peabody, Massachusetts, United States, 01960|
|Principal Investigator:||Akmal Sarwar, M.D.||Lahey Clinic, Inc.|