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Sponsored by: |
Lahey Clinic |
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Information provided by: | Lahey Clinic |
ClinicalTrials.gov Identifier: | NCT00832065 |
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.
Condition |
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Obstructive Sleep Apnea Syndrome (OSAS) Sleep Apnea Hypotestosteronemia |
Study Type: | Observational |
Study Design: | Case-Only, Prospective |
Official Title: | Sexual Dysfunction And Hypotestosteronemia In Patients With Obstructive Sleep Apnea Syndrome And Its Effects With CPAP Therapy |
Estimated Enrollment: | 200 |
Study Start Date: | January 2009 |
Estimated Study Completion Date: | September 2010 |
Estimated Primary Completion Date: | September 2009 (Final data collection date for primary outcome measure) |
Groups/Cohorts |
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1
Adult male patients between 18-70 years of age with nely diagnosed OSAS documented by all night polysomnography(PSG)
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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.
Ages Eligible for Study: | 18 Years to 70 Years |
Genders Eligible for Study: | Male |
Accepts Healthy Volunteers: | No |
Sampling Method: | Probability Sample |
Patients from the departments of Pulmonary and Critical Care and Endocrinology Lahey Clinic
Inclusion Criteria:
Exclusion Criteria:
Contact: Khalid Ismail, M.D. | 781-744-8808 | Khalid.Ismail@Lahey.org |
United States, Massachusetts | |
Lahey Clinic, Inc. | Recruiting |
Burlington, Massachusetts, United States, 01805 | |
Contact: Khalid Ismail, M.D. 781-744-8808 Khalid.Ismail@Lahey.org | |
Contact: Akmal Sarwar, M.D. 781-744-8480 Akmal.Sarwar@Lahey.org | |
Sub-Investigator: Khalid Ismail, M.D. | |
Sub-Investigator: Andre T. Guay | |
Principal Investigator: Akmal Sarwar, M.D. | |
Lahey Clinic Northshore | Recruiting |
Peabody, Massachusetts, United States, 01960 | |
Contact: Khalid Ismail, M.D. 781-744-8808 Khalid.Ismail@Lahey.org | |
Contact: Andre T. Guay, M.D. 978-538-4655 | |
Sub-Investigator: Khalid Ismail, M.D. | |
Sub-Investigator: Andre T. Guay, M.D. | |
Principal Investigator: Akmal Sarwar, M.D. |
Principal Investigator: | Akmal Sarwar, M.D. | Lahey Clinic, Inc. |
Responsible Party: | Lahey Clinic, Inc. ( Akmal Sarwar, M.D. ) |
Study ID Numbers: | 2008-066 |
Study First Received: | January 28, 2009 |
Last Updated: | July 23, 2009 |
ClinicalTrials.gov Identifier: | NCT00832065 History of Changes |
Health Authority: | United States: Institutional Review Board |
Obstructive Sleep Apnea Syndrome (OSAS) Sleep Apnea CPAP Hypotestosteronemia Sexual Dysfunction |
Signs and Symptoms Sleep Apnea Syndromes Respiratory Tract Diseases Apnea Respiration Disorders |
Sleep Apnea, Obstructive Dyssomnias Sleep Disorders Signs and Symptoms, Respiratory Sleep Disorders, Intrinsic |
Sleep Apnea Syndromes Disease Apnea Sleep Apnea, Obstructive Respiration Disorders Nervous System Diseases Dyssomnias |
Sleep Disorders Sleep Disorders, Intrinsic Signs and Symptoms Pathologic Processes Respiratory Tract Diseases Syndrome Signs and Symptoms, Respiratory |