The Impact of Obstructive Sleep Apnea in Erectile Dysfunction

April 5, 2019 updated by: Ferran Barbe, Sociedad Española de Neumología y Cirugía Torácica

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

140

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Spain
      • Lleida, Spain, 25198
        • Hospital Arnau de Vilanova. IRB Lleida. CIBERes

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 70 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Male

Description

Inclusion Criteria:

  • Diagnosis of "obstructive sleep apnea syndrome" (Apnea-Hypopnea Index >10)
  • Diagnosis of erectile dysfunction (International Index of Erectile Function score <25)
  • Signed informed consent

Exclusion Criteria:

  • Psycho-physical inability to perform or collaborate with performing tests.

  • Patients presenting any of the following conditions:

    • cardiovascular diseases, neurological diseases (multiple sclerosis, Parkinson's disease, spinal disc disease).
    • history of pelvic or retroperitoneal surgery.
    • congenital or acquired malformations (Peyronie's disease, hypospadias, epispadias, penile fracture).
    • hormonal disorders (hypogonadism, hyperprolactinemia, hyper or hypothyroidism, Cushing's disease).
    • drug addiction and/or alcoholics and treatment with any of the following drugs: antidepressants, antipsychotics.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
No Intervention: Obstructive Sleep Apnea (OSA)
OSA patients without erectile dysfunction (ED).
No Intervention: OSA + ED
OSA patients with erectile dysfunction diagnosis who are randomly allocated to not receive continuous positive airway pressure (CPAP).
Experimental: OSA + ED + CPAP
OSA patients with erectile dysfunction diagnosis who are randomly allocated to receive CPAP.
Device: Continuous positive airway pressure
Continuous positive airway pressure treatment for patients randomized to CPAP treatment group. Treatment duration: 3 months.
Other Names:
  • CPAP

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in International Index Erectile Function (IIEF) score
Time Frame: At baseline and 3 month
Effect of 3-months CPAP treatment on the changes in the International Index Erectile Function score of patients with Erectile Dysfunction.
At baseline and 3 month

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in Self-Esteem And Relationship (SEAR) score
Time Frame: At baseline and 3 month
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, using SEAR score. Evaluate the impact of CPAP treatment on the change in SEAR score after 3 months.
At baseline and 3 month
Changes in Sexual hormone profile (Testosterone, SHBG, free Testosterone, Prolactin, LH, and FSH)
Time Frame: At baseline and 3 month
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. Evaluate the impact of CPAP treatment on the change in the sexual hormone profile after 3 months. All hormones measured in blood samples by means of Radioimmunoassay.
At baseline and 3 month
Changes in Endothelial dysfunction biomarkers (ADMA, ICAM-1, VCAM-1, and VEGF)
Time Frame: At baseline and 3 month
Determine the profile of synthesis of different biomarkers related to endothelial dysfunction and cardiovascular disorder associated to obstructive sleep apnea and its relation to the risk of developing erectile dysfunction. Evaluate the impact of CPAP treatment on the changes in endothelial dysfunction biomarkers after 3 months. All markers measured in blood samples by means of Radioimmunoassay.
At baseline and 3 month

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sociedad Española de Neumología y Cirugía Torácica

Investigators

  • Principal Investigator: Ferran Barbé, MD, Spanish Respiratory Society

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 1, 2013

Primary Completion (Actual)

March 1, 2017

Study Completion (Actual)

April 1, 2017

Study Registration Dates

First Submitted

March 12, 2017

First Submitted That Met QC Criteria

March 15, 2017

First Posted (Actual)

March 22, 2017

Study Record Updates

Last Update Posted (Actual)

April 8, 2019

Last Update Submitted That Met QC Criteria

April 5, 2019

Last Verified

April 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Nº80-Separ2011

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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