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Trial registered on ANZCTR


Registration number
ACTRN12608000128392
Ethics application status
Approved
Date submitted
27/02/2008
Date registered
11/03/2008
Date last updated
25/03/2014
Type of registration
Prospectively registered

Titles & IDs
Public title
Modafinil Use in Mild-Moderate Obstructive Sleep Apnea patients.
Scientific title
Effectiveness of modafinil in improving deficits of daytime sleepiness in a randomised crossover trial in mild to moderate obstructive sleep apnea patients.
Secondary ID [1] 281578 0
There is no secondary ID
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Obstructive sleep apnea 2883 0
Condition category
Condition code
Respiratory 3021 3021 0 0
Sleep apnoea

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
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.
Intervention code [1] 2612 0
Treatment: Drugs
Comparator / control treatment
Placebo (placebo is a “Sugar pill”). Dosage frequency is one placebo per day The duration of the control treatment is 2 weeks with a 2-week washout period.
Control group
Placebo

Outcomes
Primary outcome [1] 3899 0
Primary Outcome: Mean Epworth Sleepiness Scale (ESS) score
Timepoint [1] 3899 0
Crossover trial comparing changes from each baseline until end of treatment 2 weeks later
Secondary outcome [1] 6572 0
AusEd Driving simulator 40 minute drive. The outcome variable is the mean steering deviation from the drivers median lane position.
Timepoint [1] 6572 0
Crossover trial comparing changes from each baseline until end of treatment 2 weeks later
Secondary outcome [2] 6573 0
Crossover trial comparing changes from each baseline until end of treatment 2 weeks later
Timepoint [2] 6573 0
Crossover trial comparing changes from each baseline until end of treatment 2 weeks later

Eligibility
Key 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.
Minimum age
18 Years
Maximum age
70 Years
Gender
Males
Can healthy volunteers participate?
No
Key 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
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 in a randomised order placebo-controlled crossover double blind study. At the end of the baseline visit patients will be randomly assigned, by equal chance, either 200mg modafinil or placebo (1:1 basis). All patients will receive 2 weeks of 200mg modafinil and 2 weeks of placebo, in a crossover fashion.
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
Crossover
Other design features
Phase
Not Applicable
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)
Recruitment postcode(s) [1] 594 0
2050

Funding & Sponsors
Funding source category [1] 3136 0
Charities/Societies/Foundations
Name [1] 3136 0
Woolcock Institute of Medical Research
Address [1] 3136 0
PO Box M77
Missenden Road
Camperdown NSW 2050
Country [1] 3136 0
Australia
Funding source category [2] 286373 0
University
Name [2] 286373 0
University of Sydney Bridging Grant 2010
Address [2] 286373 0
University of Sydney Camperdown 2006 NSW
Country [2] 286373 0
Australia
Primary sponsor type
Charities/Societies/Foundations
Name
Woolcock Institute of Medical Research
Address
PO Box M77
Missenden Road
Camperdown NSW 2050
Country
Australia
Secondary sponsor category [1] 2817 0
None
Name [1] 2817 0
Address [1] 2817 0
Country [1] 2817 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 5105 0
Sydney South West Area Health Services (SSWAHS) Ethics Review Committee (RPAH Zone)
Ethics committee address [1] 5105 0
c/- Research Development Office
Level 8
Building 14
Royal Prince Alfred Hospital
Missenden Road
Camperdown NSW 2050
Ethics committee country [1] 5105 0
Australia
Date submitted for ethics approval [1] 5105 0
27/02/2008
Approval date [1] 5105 0
Ethics approval number [1] 5105 0

Summary
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.
Trial website
Trial related presentations / publications
Chapman JL, Kempler L, Chang C, Williams S, Sivam S, Wong KKH, Yee BJ, Grunstein RR, Marshall NS. Modafinil improves daytime sleepiness in patients with mild-to-moderate obstructive sleep apnoea not using standard treatments. A randomised, placebo-controlled, crossover trial. 2014 THORAX 69 274-9.
http://www.ncbi.nlm.nih.gov/pubmed/24287166
Public notes

Contacts
Principal investigator
Name 28409 0
Prof Ron Grunstein
Address 28409 0
Woolcock Institute for Medical Research
PO Box M77 Missenden Rd Camperdown NSW 2050
Country 28409 0
Australia
Phone 28409 0
+61 2 9114 0000
Fax 28409 0
Email 28409 0
ron.grunstein@sydney.edu.au
Contact person for public queries
Name 11566 0
Mr Dr Nathaniel Marshall
Address 11566 0
Woolcock Institute of Medical Research
PO Box M77
Missenden Rd
Camperdown NSW 2050
Country 11566 0
Australia
Phone 11566 0
+61 02 9351 0829
Fax 11566 0
No fax number
Email 11566 0
nathaniel.marshall@sydney.edu.au
Contact person for scientific queries
Name 2494 0
Prof Professor Ron Grunstein
Address 2494 0
Woolcock Institute of Medical Research
PO Box M77
Missenden Rd
Camperdown NSW 2050
Country 2494 0
Australia
Phone 2494 0
+61 2 95158630
Fax 2494 0
+61 2 95157070
Email 2494 0
swilliams@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