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Trial registered on ANZCTR


Registration number
ACTRN12606000027516
Ethics application status
Approved
Date submitted
6/01/2006
Date registered
20/01/2006
Date last updated
11/03/2010
Type of registration
Retrospectively registered

Titles & IDs
Public title
Randomised double-blind, placebo-controlled, crossover trial on the effects of modafinil on sleep apnea patients withdrawn from continuous positive airway pressure (cpap) treatment
Scientific title
Randomised double-blind, placebo-controlled, crossover trial on the effects of modafinil on sleep apnea patients withdrawn from continuous positive airway pressure (cpap) treatment
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Obstructive sleep apnea 988 0
Condition category
Condition code
Respiratory 1064 1064 0 0
Sleep apnoea

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
This randomised double-blind, placebo-controlled study will examine the efficacy of modafinil to counteract possible daytime sleepiness after CPAP withdrawal in long-term CPAP users. Subjects will be given an 'Autoset' CPAP machine to take home to assess their CPAP compliance and subjects will also be given an Actiwatch to assess sleep-wake activity for 7 days. Subjects will then report to the laboratory where they will undergo overnight polysomnographies using CPAP for two nights and then for two nights without using CPAP. During the waking hours subjects will complete a variety of neurocognitive tasks and questionniares. After a washout period of 28 days, subjects will repeat the protocol, receiving the other study medication.
Intervention code [1] 824 0
None
Comparator / control treatment
Modafinil (200mg) or placebo tablets will be adminstered orally in the morning once daily, on mornings after CPAP withdrawal.
Control group
Placebo

Outcomes
Primary outcome [1] 1425 0
The primary outcomes that will be measured include psychomotor vigilance task (PVT) performanceanalysis.
Timepoint [1] 1425 0
The PVT will be measured whilst subjects are reporting to the laboratory at 2 hourly intervals from 0730 to 2130 hrs
Primary outcome [2] 1426 0
The primary outcomes that will be measured include EEG power spectral analysis.
Timepoint [2] 1426 0
EEG will be recorded concurrently during the driving simulator task which will occur at 1345hrs
Secondary outcome [1] 2519 0
Subjective sleepiness which will be measured by the Karolinska Sleepiness Scale using a subset of the IntegNeuro Cognitive Performance Profile.
Timepoint [1] 2519 0
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.
Secondary outcome [2] 2520 0
Driving simulator performance (AusEd Driving Simulator), symptoms of sleep disordered breathing, sleep architecture, latency and duration will also be measured.
Timepoint [2] 2520 0
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.

Eligibility
Key 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.
Minimum age
Not stated
Maximum age
Not stated
Gender
Both males and females
Can healthy volunteers participate?
No
Key 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
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
A researcher at the Woolcock not directly involved in this study will be responsible for the randomisation of subjects and maintaining the blind until after the data analyses are complete.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
An online randomisation program will be used -http://www.randomization.com/
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



Intervention assignment
Crossover
Other design features
Phase
Phase 4
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)

Funding & Sponsors
Funding source category [1] 1164 0
Commercial sector/Industry
Name [1] 1164 0
Cephalon Inc
Address [1] 1164 0
x
Country [1] 1164 0
Australia
Primary sponsor type
Other
Name
Woolcock Institute of Medical Research
Address
Country
Australia
Secondary sponsor category [1] 1025 0
University
Name [1] 1025 0
University of Sydney
Address [1] 1025 0
x
Country [1] 1025 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 2481 0
The Human Research Ethics Committee of the University of Sydney and also Sydney South West Area Health Service-Centre for Respiratory Failure and Sleep Disorders Royal Prince Alfred Hospital
Ethics committee address [1] 2481 0
Ethics committee country [1] 2481 0
Australia
Date submitted for ethics approval [1] 2481 0
Approval date [1] 2481 0
Ethics approval number [1] 2481 0
Ethics committee name [2] 2482 0
The Human Research Ethics Committee of the University of Sydney and also Sydney South West Area Health Service-Hornsby Sleep Disorders and Diagnostic Centre
Ethics committee address [2] 2482 0
Ethics committee country [2] 2482 0
Australia
Date submitted for ethics approval [2] 2482 0
Approval date [2] 2482 0
Ethics approval number [2] 2482 0

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 35109 0
Address 35109 0
Country 35109 0
Phone 35109 0
Fax 35109 0
Email 35109 0
Contact person for public queries
Name 10013 0
Sarah Newton-John
Address 10013 0
Woolcock Institute of Research
PO Box M77
Missenden Road
Camperdown NSW 2050
Country 10013 0
Australia
Phone 10013 0
+61 2 95156578
Fax 10013 0
+61 2 95505865
Email 10013 0
sarahnj@woolcock.org.au
Contact person for scientific queries
Name 941 0
Mr Shaun Williams
Address 941 0
Woolcock Institute of Research
Building F Level 6
88 Mallett Street
Camperdown NSW 2050
Country 941 0
Australia
Phone 941 0
+61 93510901
Fax 941 0
+61 93510914
Email 941 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