Sexual Dysfunction And Hypotestosteronemia In Patients With Obstructive Sleep Apnea Syndrome And Its Effects With CPAP Therapy - NCT00832065-01960 (Clinical Trial 267525)
Permalink: http://www.ClinicalConnection.com/exp/ExpandedPatientViewStudy267525.aspx
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| City: |
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Peabody |
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State:
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MA |
| Zip Code: |
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01960 |
| Conditions: |
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Obstructive Sleep Apnea Syndrome (OSAS) - Sleep Apnea - Hypotestosteronemia |
| Purpose: |
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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.
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| Study summary: |
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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. |
| Criteria: |
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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 |
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| Study is available at: |
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Lahey Clinic Northshore
Peabody, MA 01960
United States
Primary Contact:
Khalid Ismail, M.D.
Email: Khalid.Ismail@Lahey.org
Phone: 781-744-8808
Secondary Contact:
Khalid Ismail, M.D.
Email: Khalid.Ismail@Lahey.org
Phone: 781-744-8808 |
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If you are interested in this clinical trial please use the contact information above. If you would like to get additional information about this clinical trial please visit ClinicalTrials.gov.
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| Data Source: |
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ClinicalTrials.gov |
| Date Processed: |
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March 16, 2010 |
Modifications to
this listing: |
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Only selected fields are shown, please use the link
above to view all information about this clinical trial. |
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Clinical trials are medical research studies designed to test the safety and/or
effectiveness of new drugs, devices, or treatments in humans. These studies are
conducted worldwide for a range of conditions and illnesses. Learn more about
clinical research and participating in a study at
About Clinical Trials.
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