None listed
Conditions
Brief summary
This study is designed to investigate modafinil’s efficacy to improve parameters of daytime sleepiness and neurocognitive ability in untreated patients with mild to moderate OSA.
Interventions
Single dose of 200 mg modafinil once per day for 2 weeks with a 2 week washout. Mode of administration of study drug (modafinil & placebo) is oral.
Sponsors
Woolcock Institute of Medical Research
Study design
Allocation
Randomised controlled trial
Intervention model
Crossover
Primary purpose
Treatment
Masking
Blinded (masking used)
Eligibility
Sex/Gender
Male
Age
18 Years to 70 Years
Healthy volunteers
No
Inclusion criteria
Patients must be aged 18 to 70, diagnosed obstructive sleep apnea by night polysomnography (apnea-Hypopnea Index =5, = 30), refuse or cannot tolerate a continuous positive airway pressure device and/or a mandibular advancement splint and Epworth Sleepiness Score = 10.
Exclusion criteria
Patients will be excluded if they are suffering from any uncontrolled concurrent medical or psychiatric illness or if they are currently taking any medications that are known to affect sleep, or that may cause a drug interaction with modafinil; has medical conditions that would contraindicate administration of modafinil (eg, major anxiety, unstable hypertension, coronary artery disease) or has irregular sleep patterns, such as shift-workers.
Outcome results
None listed