Sexual Dysfunction And Hypotestosteronemia In Patients With Obstructive Sleep Apnea Syndrome

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ClinicalTrials.gov Identifier: NCT00832065

Recruitment Status : Withdrawn (No patients enrolled in study)

First Posted : January 29, 2009

Last Update Posted : August 24, 2017

Sponsor:

Information provided by (Responsible Party):

Lahey Clinic

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
Actual Primary Completion Date :	August 2016
Actual Study Completion Date :	August 2016

Resource links provided by the National Library of Medicine

Genetics Home Reference related topics: Obstructive sleep apnea

MedlinePlus related topics: Sleep Apnea

U.S. FDA Resources

Groups and Cohorts

Group/Cohort
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 :

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 :

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

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

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

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:

Karacan I, Karatas M. Erectile dysfunction in sleep apnea and response to CPAP. J Sex Marital Ther. 1995 Winter;21(4):239-47.

Bratel T, Wennlund A, Carlström K. Pituitary reactivity, androgens and catecholamines in obstructive sleep apnoea. Effects of continuous positive airway pressure treatment (CPAP). Respir Med. 1999 Jan;93(1):1-7.

Grunstein RR, Handelsman DJ, Lawrence SJ, Blackwell C, Caterson ID, Sullivan CE. Neuroendocrine dysfunction in sleep apnea: reversal by continuous positive airways pressure therapy. J Clin Endocrinol Metab. 1989 Feb;68(2):352-8.

Gonçalves MA, Guilleminault C, Ramos E, Palha A, Paiva T. Erectile dysfunction, obstructive sleep apnea syndrome and nasal CPAP treatment. Sleep Med. 2005 Jul;6(4):333-9.

Hoekema A, Stel AL, Stegenga B, van der Hoeven JH, Wijkstra PJ, van Driel MF, de Bont LG. Sexual function and obstructive sleep apnea-hypopnea: a randomized clinical trial evaluating the effects of oral-appliance and continuous positive airway pressure therapy. J Sex Med. 2007 Jul;4(4 Pt 2):1153-62. Epub 2006 Nov 1.

Luboshitzky R, Lavie L, Shen-Orr Z, Lavie P. Pituitary-gonadal function in men with obstructive sleep apnea. The effect of continuous positive airways pressure treatment. Neuro Endocrinol Lett. 2003 Dec;24(6):463-7.


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 CPAP Low testosterone Sexual Dysfunction

Additional relevant MeSH terms:


Sleep Apnea Syndromes Sleep Apnea, Obstructive Apnea Respiration Disorders Respiratory Tract Diseases Signs and Symptoms, Respiratory Signs and Symptoms Sleep Disorders, Intrinsic	Dyssomnias Sleep Wake Disorders Nervous System Diseases Testosterone Androgens Hormones Hormones, Hormone Substitutes, and Hormone Antagonists Physiological Effects of Drugs

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