Sexual Dysfunction And Hypotestosteronemia In Patients With Obstructive Sleep Apnea Syndrome
|ClinicalTrials.gov Identifier: NCT00832065|
Recruitment Status : Withdrawn (No patients enrolled in study)
First Posted : January 29, 2009
Last Update Posted : August 24, 2017
|Condition or disease|
|Sleep Apnea, Obstructive Sleep Apnea Hypotestosteronism|
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.
|Study Type :||Observational|
|Actual Enrollment :||0 participants|
|Official Title:||Sexual Dysfunction And Hypotestosteronemia In Patients With Obstructive Sleep Apnea Syndrome And Its Effects With CPAP Therapy|
|Actual Study Start Date :||January 2009|
|Actual Primary Completion Date :||August 2016|
|Actual Study Completion Date :||August 2016|
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)
- 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 ]
- Sexual Function Assessments. Confirmation of a link between OSAS, elevated CRP levels, and low testosterone. [ Time Frame: 3 months ]
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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.|