Sexual Dysfunction And Hypotestosteronemia In Patients With Obstructive Sleep Apnea Syndrome

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Lahey Clinic
ClinicalTrials.gov Identifier:
NCT00832065
First received: January 28, 2009
Last updated: April 17, 2014
Last verified: April 2014
  Purpose

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
Sleep Apnea, Obstructive
Sleep Apnea
Hypotestosteronism

Study Type: Observational
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

Resource links provided by NLM:


Further study details as provided by Lahey Clinic:

Primary Outcome Measures:
  • 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 ]

Secondary Outcome Measures:
  • Sexual Function Assessments. Confirmation of a link between OSAS, elevated CRP levels, and low testosterone. [ Time Frame: 3 months ] [ Designated as safety issue: No ]

Estimated Enrollment: 200
Study Start Date: January 2009
Estimated Study Completion Date: December 2014
Estimated Primary Completion Date: August 2014 (Final data collection date for primary outcome measure)
Groups/Cohorts
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)

Detailed 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.

  Eligibility

Ages Eligible for Study:   18 Years to 70 Years
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population

Patients from the departments of Pulmonary and Critical Care and Endocrinology Lahey Clinic

Criteria

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
  Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT00832065

Locations
United States, Massachusetts
Lahey Clinic, Inc.
Burlington, Massachusetts, United States, 01805
Lahey Clinic Northshore
Peabody, Massachusetts, United States, 01960
Sponsors and Collaborators
Lahey Clinic
Investigators
Principal Investigator: Akmal Sarwar, M.D. Lahey Clinic, Inc.
  More Information

Publications:
Responsible Party: Lahey Clinic
ClinicalTrials.gov Identifier: NCT00832065     History of Changes
Other Study ID Numbers: 2008-066
Study First Received: January 28, 2009
Last Updated: April 17, 2014
Health Authority: United States: Institutional Review Board

Keywords provided by Lahey Clinic:
Sleep Apnea Syndrome
Sleep Apnea
CPAP
Low testosterone
Sexual Dysfunction

Additional relevant MeSH terms:
Syndrome
Apnea
Sleep Apnea Syndromes
Sleep Apnea, Obstructive
Disease
Pathologic Processes
Respiration Disorders
Respiratory Tract Diseases
Signs and Symptoms, Respiratory
Signs and Symptoms
Sleep Disorders, Intrinsic
Dyssomnias
Sleep Disorders
Nervous System Diseases

ClinicalTrials.gov processed this record on September 18, 2014