Modafinil Use in Mild-Moderate Obstructive Sleep Apnea patients.

Not Applicable

Completed

• Conditions: Obstructive sleep apnea; Respiratory - Sleep apnoea

• Registration Number: ACTRN12608000128392
• Lead Sponsor: Woolcock Institute of Medical Research

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2008-03-11
• Study Completion: 2013-02-01
• Last Update Posted: 9 August 2022

Recruitment & Eligibility

• Status: Completed
• Sex: Male
• Target Recruitment: 32

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.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Primary Outcome: Mean Epworth Sleepiness Scale (ESS) score[Crossover trial comparing changes from each baseline until end of treatment 2 weeks later]

Secondary Outcome Measures

Name	Time	Method
AusEd Driving simulator 40 minute drive. The outcome variable is the mean steering deviation from the drivers median lane position.[Crossover trial comparing changes from each baseline until end of treatment 2 weeks later];Crossover trial comparing changes from each baseline until end of treatment 2 weeks later[Crossover trial comparing changes from each baseline until end of treatment 2 weeks later]