Erectile Dysfunction in Severe Obstructive Sleep Apnea: Effects of CPAP Therapy

December 2, 2015 updated by: Richard Schulz, University of Giessen

Erectile Dysfunction in Severe Obstructive Sleep Apnea : Effects of CPAP Therapy

Obstructive sleep apnea has been linked to erectile dysfunction. Furthermore, small studies suggest that treatment of sleep apnea by continuous positive airway pressure (CPAP) may reverse erectile dysfunction in affected patients. The present study aims to investigate in a larger cohort if severe sleep apnea is independently associated with erectile dysfunction and if 6-12 months of CPAP therapy lead to an improvement of erectile dysfunction.

Study Overview

Status

Completed

Study Type

Observational

Enrollment (Actual)

200

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 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Male

Sampling Method

Non-Probability Sample

Study Population

male patients with untreated severe sleep apnea (apnea-hypopnea-index > 30/h)

Description

Inclusion Criteria:

  • apnea-hypopnea-index > 30/h
  • no CPAP therapy
  • male gender
  • 18-80 years of age
  • having or attempting to have regular sexual intercourse

Exclusion Criteria:

  • apnea-hypopnea-index < 30/h
  • already treated by CPAP
  • female gender
  • age < 18 or > 80 years
  • not having or not attempting to have regular sexual intercourse

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change of erectile function in severe sleep apnea after 6-12 months of CPAP therapy
Time Frame: at the time of diagnosis of sleep apnea and after 6-12 months of CPAP therapy
an established self-administered questionnaire is used to assess changes in erectile function occurring after 6-12 months of CPAP therapy in patients with severe sleep apnea
at the time of diagnosis of sleep apnea and after 6-12 months of CPAP therapy

Collaborators and Investigators

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

Investigators

  • Principal Investigator: Richard Schulz, MD, University of Giessen Lung Center, Germany

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

May 1, 2012

Primary Completion (Actual)

December 1, 2015

Study Completion (Actual)

December 1, 2015

Study Registration Dates

First Submitted

May 9, 2012

First Submitted That Met QC Criteria

May 14, 2012

First Posted (Estimate)

May 16, 2012

Study Record Updates

Last Update Posted (Estimate)

December 3, 2015

Last Update Submitted That Met QC Criteria

December 2, 2015

Last Verified

December 1, 2015

More Information

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.

Clinical Trials on Obstructive Sleep Apnea

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