Continuous Positive Airway Pressure (CPAP) use in men with obstructive sleep apnoea and erectile dysfunction.

Phase 4

Completed

• Conditions: Obstructive Sleep Apnoea; Erectile Dysfunction; Respiratory - Sleep apnoea; Reproductive Health and Childbirth - Other reproductive health and childbirth disorders

• Registration Number: ACTRN12610000144011
• Lead Sponsor: HMRC

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2010-02-12
• Study Completion: 2013-03-15
• Last Update Posted: 9 August 2022

Recruitment & Eligibility

• Status: Completed
• Sex: Male
• Target Recruitment: 61

Inclusion Criteria

Males aged 18-65 with moderate to severe obstructive sleep apnoea (respiratory disturbance index >20), erectile dysfunction (International Index of Erectile Function (IIEF) <26) and in a stable heterosexual relationship for at least 6 months

Exclusion Criteria

Patients will be excluded if they require immediate treatment for obstructive sleep apnoea due to severity or increased associated risk, are suffering from any uncontrolled concurrent medical or psychiatric illness, or that may cause a drug interaction with vardenafil; has medical conditions that would contraindicate administration of vardenafil (eg, severe renal or hepatic impairment) or has irregular sleep patterns, such as shift-workers.

Study & Design

• Study Type: Interventional
• Study Design: Not specified