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)

Status

Completed

Phases

Phase 4

Study type

Interventional

Source

ANZCTR

Registry ID

ACTRN12610000144011

Acronym

CPAPED2

Enrollment

Registered

2010-02-12

Start date

2010-05-26

Completion date

2012-12-20

Last updated

2022-08-09

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Brief summary

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

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; 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.

Study design

Allocation

Randomised controlled trial

Intervention model

Factorial

Primary purpose

Treatment

Masking

Blinded (masking used)

Eligibility

Sex/Gender

Male

Age

18 Years to 65 Years

Healthy volunteers

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.

Outcome results