Randomised double-blind, placebo-controlled, crossover trial on the effects of modafinil on sleep apnea patients withdrawn from continuous positive airway pressure (cpap) treatment
Phase 4
Completed
- Conditions
- Obstructive sleep apneaRespiratory - Sleep apnoea
- Registration Number
- ACTRN12606000027516
- Lead Sponsor
- Woolcock Institute of Medical Research
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- All
- Target Recruitment
- 20
Inclusion Criteria
Diagnosed obstructive sleep apnea by night polysomnography and having an apnea hypopnea index (AHI or RDI) = 30, treated with Continuous Positive Airway Pressure (CPAP) treatment for at least one year, absence of significant co-morbidities.
Exclusion Criteria
Previous CVA, current psychotropic drug use, such as methylphenidate; clomipramine; and, monoamine oxidase inhibitors. In addition, concomitant medications that inhibit or are metabolised by cytochrome p-450 isoenzymes and other hepatic enzymes and daytime blood pressure exceeds >160mmHg/>100mmHg at the baseline visit.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method The primary outcomes that will be measured include psychomotor vigilance task (PVT) performanceanalysis.[The PVT will be measured whilst subjects are reporting to the laboratory at 2 hourly intervals from 0730 to 2130 hrs];The primary outcomes that will be measured include EEG power spectral analysis.[EEG will be recorded concurrently during the driving simulator task which will occur at 1345hrs]
- Secondary Outcome Measures
Name Time Method Subjective sleepiness which will be measured by the Karolinska Sleepiness Scale using a subset of the IntegNeuro Cognitive Performance Profile. [These outcome variables will be recorded whilst subjects are reporting to the laboratory between 0730 and 2130 hrs, except symptoms of sleep disordered breathing which will form part of overnight polysomnographies.];Driving simulator performance (AusEd Driving Simulator), symptoms of sleep disordered breathing, sleep architecture, latency and duration will also be measured.[These outcome variables will be recorded whilst subjects are reporting to the laboratory between 0730 and 2130 hrs, except symptoms of sleep disordered breathing which will form part of overnight polysomnographies.]