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The Impact of Obstructive Sleep Apnea in Erectile Dysfunction

NCT03086122 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 140

Last updated 2019-04-08

No results posted yet for this study

Summary

The syndrome of obstructive sleep apnea (OSA) is a common condition that affects 2-4% of the general population, causing an increase in sympathetic activity, changes in systemic blood pressure, and is associated with cardiovascular disease. The pathophysiological mechanisms that are altered as a result of the events associated with obstructive sleep apnea (hypoxia-reoxygenation, arousals and sleep fragmentation), are associated with an increased risk of developing erectile dysfunction in patients with Obstructive Sleep Apnea. Until today, the studies linking Erectile Dysfunction with Obstructive Sleep Apnea (OSA) are epidemiological studies.

The alterations in the expression profile of endothelial and cardiovascular dysfunction biomarkers and sex hormones disorders that are altered as a result of the events associated with OSA are associated to erectile dysfunction development.

Treatment with continuous positive airway pressure (CPAP) reverses the effects of OSA and patients with erectile dysfunction may improve erectile function.

The primary objective of the study is:

1\. To evaluate the impact of CPAP treatment on erectile dysfunction in OSA patients.

The secondary objectives are:

1. To determine the profile of synthesis of different biomarkers related to endothelial dysfunction and cardiovascular disorder, which are altered as a result of the syndrome of obstructive sleep apnea and its relation to the risk of developing erectile dysfunction.
2. To compare the secretion profile of sex hormones related to control erectile function in a group of patients with syndrome of obstructive sleep apnea with and without erectile dysfunction.
3. To assess the prevalence of erectile dysfunction in patients with OSA.
4. To compare the psychological profile of patients with OSA with and without erectile dysfunction in order to detect psychological distress associated with the risk of developing erectile dysfunction.
5. To evaluate the impact of CPAP treatment on the secretion profile of sex hormones related to control erectile function in OSA patients.
6. To evaluate the impact of CPAP treatment on the psychological profile of patients with erectile disfunction in OSA patients.

Conditions

Interventions

DEVICE

Continuous positive airway pressure

Continuous positive airway pressure treatment for patients randomized to CPAP treatment group. Treatment duration: 3 months.

Sponsors & Collaborators

  • Sociedad Española de Neumología y Cirugía Torácica

    lead OTHER

Principal Investigators

  • Ferran Barbé, MD · Spanish Respiratory Society

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
70 Years
Sex
MALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2013-04-30
Primary Completion
2017-03-31
Completion
2017-04-30

Countries

  • Spain

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03086122 on ClinicalTrials.gov