Clinical trial NCT00832065: Sexual Dysfunction And Hypotestosteronemia In Patients With Obstructive Sleep Apnea Syndrome
Official title: Sexual Dysfunction And Hypotestosteronemia In Patients With Obstructive Sleep Apnea Syndrome And Its Effects With CPAP Therapy
Study type: OBSERVATIONAL
Overall status: WITHDRAWN
Conditions: Sleep Apnea, Obstructive
Sleep Apnea
Hypotestosteronism
Keywords: Sleep Apnea Syndrome
Sleep Apnea
CPAP
Low testosterone
Sexual Dysfunction
Lead sponsor: Lahey Clinic
Sponsor class: OTHER
First posted: 2009-01-29
Enrollment: 0
Sex: MALE
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients from the departments of Pulmonary and Critical Care and Endocrinology Lahey Clinic

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.

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 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

Primary outcomes:
measure: 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
timeFrame: 3 months
Secondary outcomes:
measure: Sexual Function Assessments. Confirmation of a link between OSAS, elevated CRP levels, and low testosterone.
timeFrame: 3 months
Other outcomes:
Locations:
city: Burlington
country: United States
facility: Lahey Clinic, Inc.
state: Massachusetts
city: Peabody
country: United States
facility: Lahey Clinic Northshore
state: Massachusetts
Study officials:
affiliation: Lahey Clinic, Inc.
name: Akmal Sarwar, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
citation: Karacan I, Karatas M. Erectile dysfunction in sleep apnea and response to CPAP. J Sex Marital Ther. 1995 Winter;21(4):239-47. doi: 10.1080/00926239508414643.
citation: Bratel T, Wennlund A, Carlstrom 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. doi: 10.1016/s0954-6111(99)90068-9.
citation: 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. doi: 10.1210/jcem-68-2-352.
citation: Goncalves 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. doi: 10.1016/j.sleep.2005.03.001.
citation: 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. doi: 10.1111/j.1743-6109.2006.00341.x. Epub 2006 Nov 1.
citation: 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.