Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12606000005550
Ethics application status
Approved
Date submitted
3/01/2006
Date registered
4/01/2006
Date last updated
11/03/2010
Type of registration
Retrospectively registered

Titles & IDs
Public title
Inter-individual differences after continuous positive airway pressure (CPAP) withdrawal in mild sleep apnoea patients, evaluated by their performance on a simulated driving task – A role for modafinil?
Scientific title
Inter-individual differences after continuous positive airway pressure (CPAP) withdrawal in mild sleep apnoea patients, evaluated by their performance on a simulated driving task – A role for modafinil?
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Obstructive sleep apnea (OSA) 966 0
Condition category
Condition code
Respiratory 1038 1038 0 0
Sleep apnoea

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
This double-blind, placebo-controlled study will examine the efficacy of modafinil to counteract possible daytime sleepiness after one night of CPAP withdrawal in long-term CPAP users.

Sleep-wake activity on CPAP use will be assessed for 5 days using actigraphy. On the 5th night subjects will withdrew from CPAP treatment and use a nasal airflow device as a substitute. The following morning, subjects will report to the laboratory and received modafinil (200 mg). EEG will be assessed continuously and then a 30 min driving simulation task (STISIM TM) will be completed 2 hours post drug administration. After a washout period of 14 days, subjects will repeat the protocol, receiving the other study medication.
Intervention code [1] 820 0
None
Comparator / control treatment
Sleep-wake activity on CPAP use will be assessed for 5 days using actigraphy. On the 5th night subjects will withdrew from CPAP treatment and use a nasal airflow device as a substitute. The following morning, subjects will report to the laboratory and received a placebo. EEG will be assessed continuously and then a 30 min driving simulation task (STISIM TM) will be completed 2 hours post drug administration. After a washout period of 14 days, subjects will repeat the protocol, receiving the other study medication.
Control group
Placebo

Outcomes
Primary outcome [1] 1388 0
The primary outcome that will be measured is driving simulator performance. Specifically the primary outcome variables that will be measured includes lane deviation.
Timepoint [1] 1388 0
The primary outcome variables will be measured concurrently during the driving simulator task. These outcome variables will be measured starting at approximately 0900hrs.
Primary outcome [2] 1389 0
The primary outcome that will be measured is driving simulator performance. Specifically the primary outcome variables that will be measured includes reaction time to divided attention probes.
Timepoint [2] 1389 0
The primary outcome variables will be measured concurrently during the driving simulator task. These outcome variables will be measured starting at approximately 0900hrs.
Primary outcome [3] 1390 0
The primary outcome that will be measured is driving simulator performance. Specifically the primary outcome variables that will be measured includes EEG power spectral analysis.
Timepoint [3] 1390 0
The primary outcome variables will be measured concurrently during the driving simulator task. These outcome variables will be measured starting at approximately 0900hrs.
Secondary outcome [1] 2455 0
Assessment of change in subjective sleepiness measured by the Karolinska Sleepiness Scale, assesment of Critical flicker fusion thresholds, actigraphical assesment of sleep-wake activity and nasal airflow upon CPAP withdrawal.
Timepoint [1] 2455 0
These outcome variables were measured at approximately 0900hrs, except for Actigraphy which was done for a 5 day period.

Eligibility
Key inclusion criteria
Minimum age
30 Years
Maximum age
60 Years
Sex
Males
Can healthy volunteers participate?
No
Key exclusion criteria

Study design
Purpose of the study
Treatment
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



Intervention assignment
Crossover
Other design features
Phase
Phase 3
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
1/01/2006
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
20
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 1138 0
Other
Name [1] 1138 0
Woolcock Institute of Medical Research
Country [1] 1138 0
Australia
Primary sponsor type
Other
Name
Woolcock Institute of Medical Research
Address
Country
Australia
Secondary sponsor category [1] 995 0
University
Name [1] 995 0
University of Sydney, Department of Pharmacology
Address [1] 995 0
x
Country [1] 995 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 2459 0
Centre for Respiratory Failure and Sleep Disorders Royal Prince Alfred Hospital and Psychopharmacology Unit, Rozelle Hospital
Ethics committee address [1] 2459 0
Ethics committee country [1] 2459 0
Australia
Date submitted for ethics approval [1] 2459 0
Approval date [1] 2459 0
Ethics approval number [1] 2459 0

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

Contacts
Principal investigator
Name 36199 0
Address 36199 0
Country 36199 0
Phone 36199 0
Fax 36199 0
Email 36199 0
Contact person for public queries
Name 10009 0
Sarah Newton-John
Address 10009 0
Woolcock Institute of Research
PO Box M77
Missenden Road
Camperdown NSW 2050
Country 10009 0
Australia
Phone 10009 0
+61 2 95156578
Fax 10009 0
+61 2 95505865
Email 10009 0
sarahnj@woolcock.org.au
Contact person for scientific queries
Name 937 0
Shaun Williams
Address 937 0
Woolcock Institute of Research
Level 6 Building F
88 Mallett Street
Camperdown NSW 2050
Country 937 0
Australia
Phone 937 0
+61 2 93510901
Fax 937 0
+61 2 93510914
Email 937 0
swilliams@woolcock.org.au

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.