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Trial registered on ANZCTR


Registration number
ACTRN12610000144011
Ethics application status
Approved
Date submitted
5/02/2010
Date registered
12/02/2010
Date last updated
4/03/2014
Type of registration
Prospectively registered

Titles & IDs
Public title
Continuous Positive Airway Pressure (CPAP) use in men with obstructive sleep apnoea and erectile dysfunction.
Scientific title
The effect of Continuous Positive Airway Pressure (CPAP) on Erectile and Endothelial Dysfunction in Impotent men with Obstructive Sleep Apnoea (OSA)
Secondary ID [1] 1398 0
nil
Universal Trial Number (UTN)
Trial acronym
CPAPED2
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Obstructive Sleep Apnoea 256763 0
Erectile Dysfunction 256764 0
Condition category
Condition code
Respiratory 256914 256914 0 0
Sleep apnoea
Reproductive Health and Childbirth 256915 256915 0 0
Other reproductive health and childbirth disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
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.
Intervention code [1] 255975 0
Treatment: Drugs
Intervention code [2] 255976 0
Treatment: Devices
Comparator / control treatment
The placebo given is produced by the manufacturer of the active drug, Bayer Schering, and is identical to the active tablet in every way except that the active ingredient is not added.

Sham CPAP has the same physical appearance and method of use as a 'real' CPAP system - a modification of the Respironics REMstar PRO II. This has internal modifications which limit the amount of airflow delivered to the patient. The patient interface (mask) has a modification to the mask elbow which allows for great-than-normal amounts of air to escape the system, eliminating accumulation of carbon dioxide in the mask dead space.
Control group
Placebo

Outcomes
Primary outcome [1] 257789 0
Erectile function via the international index of erectile function (IIEF)
Timepoint [1] 257789 0
Baseline, and 4, 8 and 12 weeks after intervention commences
Secondary outcome [1] 263194 0
Vascular reactivity (flow mediated dilatation, peripheral arterial tenometry and repair (endothelial progenitor cell assessment)
Timepoint [1] 263194 0
Baseline and 12 weeks after intervention commences
Secondary outcome [2] 263195 0
Heart Rate Variability, measured via pulse wave analysis using a non-invasive brachial sphygmomanometer.
Timepoint [2] 263195 0
Baseline and 12 weeks after intervention commences
Secondary outcome [3] 263196 0
Pulse Wave Analysis using a non-invasive brachial sphygmomanometer.
Timepoint [3] 263196 0
Baseline and 12 weeks after intervention commences
Secondary outcome [4] 263197 0
Nocturnal Penile Tumescence, measured via a Rigiscan monitor.
Timepoint [4] 263197 0
Baseline and 12 weeks after intervention commences
Secondary outcome [5] 273159 0
Hormone and other blood parameters (including luteinizing hormone, Testosterone, estradiol, adrenocorticotropic hormone, cortisol, growth hormone, lipids, glucose, insulin, insulin like growth factor-1, HbA1C)
Timepoint [5] 273159 0
Baseline and 12 weeks after intervention commences
Secondary outcome [6] 273160 0
Relationship, sexual functioning (both male and female partners) and quality of life questionnaires (including European Male Aging Study, Self Esteem and Relationship Scale, Female Sexual Functioning Index, Erectile Dysfunction Inventory of Treatment Satisfaction, partner Erectile Dysfunction Inventory of Treatment Satisfaction, Epworth Sleepiness Scale, Depression Anxiety Stress Scale, Functional Outcomes of Sleep Questionnaire, SF-36
Timepoint [6] 273160 0
Baseline, and 4, 8 and 12 weeks after intervention commences
Secondary outcome [7] 273161 0
Sleep and breathing parameters using nocturnal polysomnography
Timepoint [7] 273161 0
Baseline and 12 weeks after intervention commences
Secondary outcome [8] 273162 0
Effects of treatment on partner - Sleep quality (actigraphy) and pulse wave analysis (non-invasive brachial sphygmomanometer).
Timepoint [8] 273162 0
Baseline and 12 weeks after intervention commences

Eligibility
Key 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
Minimum age
18 Years
Maximum age
65 Years
Gender
Males
Can healthy volunteers participate?
No
Key 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
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
After written consent, patients will be enrolled sequentially according to the randomisation list generated via a computer programme (ie computerised sequence generation), the outcome of which will result in numbered containers distributed to sequentially enrolled subjects. The Patients will be randomised to one of 4 groups: CPAP and vardenafil, sham CPAP and vardenafil, CPAP and placebo, sham CPAP and placebo
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Simple randomisation by using a randomisation table created by computer software (i.e., computerised sequence generation).
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



Intervention assignment
Factorial
Other design features
2 x 2 Factorial design -
1) CPAP and vardenafil
2) sham CPAP and vardenafil
3) CPAP and placebo
4) sham CPAP and placebo
Phase
Phase 4
Type of endpoint(s)
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 256475 0
Government body
Name [1] 256475 0
National Health and Medical Research Council (NHMRC)
Address [1] 256475 0
Level 1, 16 Marcus Clarke Street
Canberra ACT 2601
Country [1] 256475 0
Australia
Primary sponsor type
Government body
Name
NHMRC
Address
Level 1, 16 Marcus Clarke Street
Canberra ACT 2601
Country
Australia
Secondary sponsor category [1] 255783 0
None
Name [1] 255783 0
NA
Address [1] 255783 0
NA
Country [1] 255783 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 258526 0
Ethics Review Committee Concord Repatriation Hospital
Ethics committee address [1] 258526 0
Research Development Office
Level 1 Building 75,
Concord Repatriation General Hospital
Hospital Road, Concord West 2138 NSW
Ethics committee country [1] 258526 0
Australia
Date submitted for ethics approval [1] 258526 0
18/11/2009
Approval date [1] 258526 0
20/01/2010
Ethics approval number [1] 258526 0
09/CRGH/243

Summary
Brief summary
This study is to investigate the efficacy of vardenafil and CPAP on erectile dysfunction and obstructive sleep apnoea
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 30809 0
A/Prof Peter Liu
Address 30809 0
Woolcock Institute of Medical Research
431 Glebe Point Road
Glebe NSW 2037
Country 30809 0
Australia
Phone 30809 0
+61291140498
Fax 30809 0
Email 30809 0
pliu@mail.med.edu.au
Contact person for public queries
Name 14056 0
Ms Kerri Melehan
Address 14056 0
The Woolcock Institute of Medical Research
431 Glebe Point Road,
Glebe 2037 NSW
Country 14056 0
Australia
Phone 14056 0
+61 2 9114 0000
Fax 14056 0
+61 2 9114 0010
Email 14056 0
kerrim@woolcock.org.au
Contact person for scientific queries
Name 4984 0
A/Prof A/Prof Peter Liu
Address 4984 0
The Woolcock Institute of Medical Research
431 Glebe Point Road,
Glebe 2037 NSW
Country 4984 0
Australia
Phone 4984 0
+61 2 9114 0000
Fax 4984 0
+61 2 9114 0010
Email 4984 0
kerrim@woolcock.org.au

No information has been provided regarding IPD availability
Summary results
Have study results been published in a peer-reviewed journal?
Other publications
Have study results been made publicly available in another format?
Results – basic reporting
Results – plain English summary