Obstructive Sleep ApneaNCT01600066
Erectile Dysfunction in Severe Obstructive Sleep Apnea: Effects of CPAP Therapy
An observational study of Obstructive Sleep Apnea and Erectile Dysfunction, run by University of Giessen.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 80 years, men only
- Conditions the study is for
- Obstructive Sleep Apnea, Erectile Dysfunction
- How many people
- 200 participants
- Where
- No sites listed yet
- Study dates
- May 2012to Dec 2015
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- Men only
- No healthy volunteers
- Adult, Older adult
Study population: male patients with untreated severe sleep apnea (apnea-hypopnea-index > 30/h)
Who may be able to join
- apnea-hypopnea-index > 30/h
- no CPAP therapy
- male gender
- 18-80 years of age
- having or attempting to have regular sexual intercourse
Who cannot join
- 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
About this study
Official title: 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.
- Conditions
- Obstructive Sleep Apnea, Erectile Dysfunction
- Medical subject headings
- Sleep Apnea, Obstructive, Erectile Dysfunction
What is being measured
The primary outcome is the main question the study is designed to answer.
Change of erectile function in severe sleep apnea 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
Measured: at the time of diagnosis of sleep apnea and after 6-12 months of CPAP therapy
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 May 2012 (estimated)
- Study startMay 2012
- Primary completionDec 2015
- Study completionDec 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Obstructive Sleep ApneaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 200 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Giessen
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Richard Schulz, University of Giessen
- Investigators
- Richard Schulz, MD, Principal investigator, University of Giessen Lung Center, Germany
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01600066
- Sponsor's protocol ID
- GERSAN-1
- Other IDs
- UGLC
- Status last verified
- Dec 2015
- First submitted
- 9 May 2012
- Last updated
- 3 Dec 2015
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 3 Dec 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Erectile Dysfunction in Severe Obstructive Sleep Apnea : Effects of CPAP Therapy
- ClinicalTrials.gov ID
- NCT01600066
- Acronym / sponsor ID
- GERSAN-1
- Conditions
- Obstructive Sleep Apnea, Erectile Dysfunction
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 200 participants (actual)
- Lead sponsor
- University of GiessenUniversity, hospital or other
- Study start
- May 2012
- Primary completion
- Dec 2015 (actual)
- Study completion
- Dec 2015 (actual)
- First posted
- 16 May 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 80 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- male patients with untreated severe sleep apnea (apnea-hypopnea-index > 30/h)
Key inclusion criteria (5 listed)
- apnea-hypopnea-index > 30/h
- no CPAP therapy
- male gender
- 18-80 years of age
- having or attempting to have regular sexual intercourse
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Dec 2015.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Richard Schulz, MD principal investigator
University of Giessen Lung Center, Germany
Questions about this trial
What is this clinical trial studying?
An observational study of Obstructive Sleep Apnea and Erectile Dysfunction, run by University of Giessen.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 3 Dec 2015. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Dec 2015.