Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12606000250538
Ethics application status
Approved
Date submitted
20/06/2006
Date registered
20/06/2006
Date last updated
27/11/2018
Date data sharing statement initially provided
27/11/2018
Type of registration
Retrospectively registered

Titles & IDs
Public title
Evaluating waking function in patients with obstructive sleep apnea (OSA) on long term continuous positive airway pressure (CPAP).
Scientific title
Evaluating waking function in patients with obstructive sleep apnea (OSA) on long term continuous positive airway pressure (CPAP).
Universal Trial Number (UTN)
Trial acronym
NSCPAP
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Obstructive sleep apnea (OSA) 1229 0
Condition category
Condition code
Respiratory 1312 1312 0 0
Sleep apnoea

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
This randomised, case-controlled project aims to aid in developing a performance test battery that can be utilised by sleep physicians in order to assess an obstructive sleep apnea (OSA) subject’s performance and sleepiness level after they have been treated with continuous positive airway pressure (CPAP). Subjects will be given an 'Autoset' CPAP machine and sleep-wake activity will be assessed for 7 days using actigraphy. Subjects will then report to the laboratory where they will undergo two overnight polysomnographies (PSG) whilst using CPAP. During the waking hours subjects will complete a variety of neurocognitive tasks and questionnaires. After a washout period of 28 days subjects will repeat the protocol, except following the first PSG they will complete a 41 hours and 55 min sleep deprivation period. A recovery night will follow the sleep deprivation period.
Intervention code [1] 1150 0
Prevention
Comparator / control treatment
Control subjects will complete the procedures which intervention group does except without the use of a CPAP machine.
Control group
Active

Outcomes
Primary outcome [1] 1794 0
Primary variables include the total number of lapses (defined as reaction time (RT)>500ms) during a 10 min psychomotor vigilance task (PVT)
Timepoint [1] 1794 0
The PVT will be measured whilst subjects are reporting to the laboratory at 2 hourly intervals from 0730 to 2330 hrs whilst electroencephalogram (EEG) will be recorded concurrently.
Primary outcome [2] 1795 0
Primary variables include the mean slowest 10% metric of the PVT.
Timepoint [2] 1795 0
The PVT will be measured whilst subjects are reporting to the laboratory at 2 hourly intervals from 0730 to 2330 hrs whilst electroencephalogram (EEG) will be recorded concurrently.
Secondary outcome [1] 3149 0
Secondary variables include EEG power spectral analysis, subjective alertness and functioning capabilities; other measures of neurocognitive assessments, including working memory function, cognitive throughput, driving simulator performance (AusEd Driving Simulator); measures of sleep, including symptoms of sleep disordered breathing, sleep architecture, sleep latency and duration.
Timepoint [1] 3149 0
These outcome variables will be recorded whilst subjects are reporting to the laboratory between 0730 and 2330 hrs, except symptoms of sleep disordered breathing which will form part of overnight PSGs.

Eligibility
Key inclusion criteria
Diagnosed OSA by night polysomnography with an apnea hypopnea index (AHI) =10, receiving optimal CPAP treatment for at least 6months, Epworth Sleepiness Score (ESS) = 10, absence of significant co-morbidities.
Minimum age
22 Years
Maximum age
63 Years
Sex
Males
Can healthy volunteers participate?
No
Key exclusion criteria
Previous cerebral vascular accident (CVA), head injury, history of neurological disorders (including depression), history of unstable hypertension (blood pressure (BP) cannot exceed>160mmHg/.100mmHg), psychotropic drug use, received investigational drug within last 60 days, significant respiratory disease, significant renal or hepatic impairment, use of stimulant/sleeping tablets, shift workers and non-English speaking subjects.

Study design
Purpose of the study
Prevention
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.
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
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Crossover
Other design features
Phase
Type of endpoint/s
Safety/efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Withdrawn
Reason for early stopping/withdrawal
Lack of funding/staff/facilities
Date of first participant enrolment
Anticipated
1/06/2006
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
24
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 1438 0
Government body
Name [1] 1438 0
NHMRC
Country [1] 1438 0
Australia
Primary sponsor type
Other
Name
Woolcock Institute of Medical Research
Address
Country
Australia
Secondary sponsor category [1] 1272 0
University
Name [1] 1272 0
University of Sydney
Address [1] 1272 0
Country [1] 1272 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 2813 0
Hornsby Sleep Disorders and Diagnostic Centre
Ethics committee address [1] 2813 0
Waitara, NSW
Ethics committee country [1] 2813 0
Australia
Date submitted for ethics approval [1] 2813 0
Approval date [1] 2813 0
01/04/2006
Ethics approval number [1] 2813 0
04-2006/3/9028

Summary
Brief summary
This project aims to developing a performance test battery that can be utilised by sleep physicians in order to assess an obstructive sleep apnea (OSA) subject's performance and sleepiness level after they have been treated with continuous positive airway pressure (CPAP). To facilitate this OSA subjects' performances will be assessed by a number of psychomotor tasks, cognitive tasks and objective measures of sleepiness. OSA subjects and also controls will be tested during their normal state and also during a sleep deprived state so that comparisons can be made between the two groups and across the two different conditions.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 35323 0
Address 35323 0
Country 35323 0
Phone 35323 0
Fax 35323 0
Email 35323 0
Contact person for public queries
Name 10339 0
Sarah Newton-John
Address 10339 0
PO Box M77 Missenden Road
Camperdown NSW 2050
Country 10339 0
Australia
Phone 10339 0
+61 2 95156578
Fax 10339 0
+61 2 95505865
Email 10339 0
[email protected]
Contact person for scientific queries
Name 1267 0
Mr Shaun Williams
Address 1267 0
Level 6 Building F
88 Mallett Street
Camperdown NSW 2050
Country 1267 0
Australia
Phone 1267 0
+61 2 93510901
Fax 1267 0
+61 2 93510914
Email 1267 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No/undecided IPD sharing reason/comment


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.