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

Obstructive Sleep Apnea Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01600066
• Other study ID #: GERSAN-1
• Secondary ID: UGLC
• Status: Completed
• Phase: N/A
• First received: May 9, 2012
• Last updated: December 2, 2015
• Start date: May 2012
• Est. completion date: December 2015

Study information

• Verified date: December 2015
• Source: University of Giessen
• Contact: n/a
• Is FDA regulated: No
• Health authority: Germany: Ministry of Health
• Study type: Observational

Clinical 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. 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 200
• Est. completion date: December 2015
• Est. primary completion date: December 2015
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 18 Years to 80 Years

Eligibility

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 Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Apnea
• Erectile Dysfunction
• Obstructive Sleep Apnea
• Sleep Apnea Syndromes
• Sleep Apnea, Obstructive

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
University of Giessen

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	at the time of diagnosis of sleep apnea and after 6-12 months of CPAP therapy	No