Moderate to Severe Obstructive Sleep Apnea Patients with Residual Excessive Daytime Sleepinesss after Suboptimal Usage of Continuous Positive Airway Pressure Treatment Obstructive sleep apnea Armodafinil Residual Excessive daytime sleepiness Nearly optimal usage continuous positive airway pressure CPAP OSA
Conditions
Interventions
Wakefulness promotor Armodafinil 150 mg/day
Total 12 weeks period
Experimental Drug
Armodafinil 150 mg per oral per day
Sponsors
Ratchadapiseksompoj funds
Eligibility
Sex/Gender
All
Age
18 Years to 65 Years
Inclusion criteria
Inclusion criteria: Patient who diagnosed with moderate to severe OSA and still have excessive daytime sleepiness defined as ESS >10 and have received stable CPAP therapy at least 4 weeks but in suboptimal usage patient naive to Armodafinil
Exclusion criteria
Exclusion criteria: 1. Patient who was diagnosed with sleep disorders other than OSA 2. Patient who has clinically significant or uncontrolled medical condition, treated and untreated, or any disorder that might interfere with drug absorption, distribution, metabolism, excretion or produce daytime sleepiness 3. Patient use prescription drugs disallowed by protocol* or clinically significant use of over-the-counter drugs within 7 days before baseline visit 4. Patient with history of alcohol, narcotics, or any other recreational drug abuse 5. Patient with excessive consumption of caffeine > 600 mg/day or > 8 cups/day 6. Patient who is pregnancy or lactation 7. Patients with psychiatric disorders 8. Patients with cardiovascular disorder - History of Left Ventricular Hypertrophy (LVH) - Mitral Valve Prolapse (MVP) who have experienced MVP syndrome with previous CNS stimulant exposure - Unstable Cardiovascular (CV) disease - Moderate to severe symptomatic Cardiovasbular (CV) disease 9. Patients with abnormal ECG at baseline or uncontrolled blood pressure ( >180/100 mmHg)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Epworth sleepiness scale 12 weeks Questionaire | — |
Secondary
| Measure | Time frame |
|---|---|
| Clinical global improvement 12 weeks Questionaire,Pittsburgh sleep quality index 12 weeks Questionaire,OSLER test 12 weeks Test, non invasive,Safety variables 12 weeks ECG and physical examination with patient report,Sleep report and drink consumption Across research period Sleep diary | — |
Countries
Thailand
Contacts
Public ContactJinjuta Ngeyvijit
Faculty of Medicine, Chulalongkorn University
Outcome results
None listed