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Sexual Dysfunction And Hypotestosteronemia In Patients With Obstructive Sleep Apnea Syndrome

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00832065
Recruitment Status : Withdrawn (No patients enrolled in study)
First Posted : January 29, 2009
Last Update Posted : August 24, 2017
Information provided by (Responsible Party):

Study Description
Brief Summary:
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 or disease
Sleep Apnea, Obstructive Sleep Apnea Hypotestosteronism

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.

Study Design

Study Type : Observational
Actual Enrollment : 0 participants
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
Actual Study Start Date : January 2009
Primary Completion Date : August 2016
Study Completion Date : August 2016

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Sleep Apnea
U.S. FDA Resources

Groups and 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)

Outcome Measures

Primary Outcome Measures :
  1. 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 ]

Secondary Outcome Measures :
  1. Sexual Function Assessments. Confirmation of a link between OSAS, elevated CRP levels, and low testosterone. [ Time Frame: 3 months ]

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Senior)
Sexes 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

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

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
Sponsors and Collaborators
Lahey Clinic
Principal Investigator: Akmal Sarwar, M.D. Lahey Clinic, Inc.
More Information

Responsible Party: Lahey Clinic
ClinicalTrials.gov Identifier: NCT00832065     History of Changes
Other Study ID Numbers: 2008-066
First Posted: January 29, 2009    Key Record Dates
Last Update Posted: August 24, 2017
Last Verified: August 2017

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

Additional relevant MeSH terms:
Sleep Apnea Syndromes
Sleep Apnea, Obstructive
Respiration Disorders
Respiratory Tract Diseases
Signs and Symptoms, Respiratory
Signs and Symptoms
Sleep Disorders, Intrinsic
Sleep Wake Disorders
Nervous System Diseases
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs