CompletedPhase 4ACTRN12610000144011

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

The effect of Continuous Positive Airway Pressure (CPAP) on Erectile and Endothelial Dysfunction in Impotent men with Obstructive Sleep Apnoea (OSA)

Sponsor

NHMRC

Enrollment

100 participants

Start Date

May 26, 2010

Study Type

Interventional

Conditions

Erectile Dysfunction

Summary

This study is to investigate the efficacy of vardenafil and CPAP on erectile dysfunction and obstructive sleep apnoea

Eligibility

Sex: MalesMin Age: 18 YearssMax Age: 65 Yearss

Plain Language Summary

Simplified for easier understanding

This study tests whether using a CPAP breathing machine during sleep can improve erectile function in men with obstructive sleep apnea. Males aged 18 to 65 with moderate to severe sleep apnea and erectile difficulties who are in a stable relationship may participate.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

Participants will be randomised to one of 4 groups. These 4 groups will be receiving different exposures: Group 1: CPAP and vardenafil; Group 2: sham CPAP and vardenafil; Group 3: CPAP and placebo; G

Participants will be randomised to one of 4 groups. These 4 groups will be receiving different exposures: Group 1: CPAP and vardenafil; Group 2: sham CPAP and vardenafil; Group 3: CPAP and placebo; Group 4: sham CPAP and placebo. CPAP will be delivered via a nasal mask at a pressure which has been titrated for each patients requirement to maintain an open airway, and will be in the range between 4-20cmH2O. Sham CPAP will be delivered via nasal mask in the same manner as CPAP. The pressure delivered is subtheraputic, typically below 1cmH2O. Subjects are asked to use the CPAP or sham-CPAP every sleep period during the 12 week study period. Typically, this exposure is 4-8hours per night. Vardenafil and placebo are administered every evening, one hour before bed, via an oral capsule, for each of the nights in the 12 week study period.