- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01600066
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
Conditions
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.
Sponsor
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
Terms related to this study
Additional Relevant MeSH Terms
- Mental Disorders
- Nervous System Diseases
- Respiratory Tract Diseases
- Respiration Disorders
- Sleep Disorders, Intrinsic
- Dyssomnias
- Sleep Wake Disorders
- Signs and Symptoms, Respiratory
- Sexual Dysfunctions, Psychological
- Sexual Dysfunction, Physiological
- Sleep Apnea Syndromes
- Sleep Apnea, Obstructive
- Apnea
- Erectile Dysfunction
Other Study ID Numbers
- GERSAN-1
- UGLC (Other Identifier: UGLC)
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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