Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12607000424404
Ethics application status
Approved
Date submitted
15/08/2007
Date registered
22/08/2007
Date last updated
7/07/2022
Date data sharing statement initially provided
7/07/2022
Date results information initially provided
7/07/2022
Type of registration
Prospectively registered

Titles & IDs
Public title
Increasing adherence to Obstructive Sleep Apnea (OSA) treatment with a cognitive Behavioural therapy (CBT) intervention
Scientific title
Increasing adherence to Obstructive Sleep Apnea (OSA) treatment with a cognitive Behavioural therapy (CBT) intervention
Secondary ID [1] 281001 0
Nil.
Universal Trial Number (UTN)
Trial acronym
Increasing adherence to OSA with a CBT intervention
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Obstructive Sleep Apnea 2258 0
Adherence to treatment which is Continuous Positive Airway Pressure 2259 0
Condition category
Condition code
Respiratory 2349 2349 0 0
Sleep apnoea

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Continuous positive airway pressure treatment (CPAP); a one session group cognitive behavioural therapy intervention to promote CPAP acceptance and adherence, duration approximately 1 hour; and a 1 hour social reciprocity control treatment to assess if time spent with individuals increases CPAP acceptance and adherence.
Intervention code [1] 1970 0
Treatment: Devices
Intervention code [2] 1971 0
Behaviour
Comparator / control treatment
Social Reciprocity – this control is designed to determine the influence of social support on CPAP acceptance and adherence. During the social reciprocity session participants will be shown a video on sleep and healthy lifestyle and information on how to contact local CPAP support groups will be provided. Tea and coffee will be served to participants after the video and there will be an opportunity to talk with other participants.
Control group
Active

Outcomes
Primary outcome [1] 3245 0
Primary Outcome 1: Acceptance and uptake of CPAP usage
Timepoint [1] 3245 0
Time point for Outcome 1: 1month, 3 months, 6 months following intervention
Primary outcome [2] 3246 0
Primary Outcome 2: Average Nightly CPAP usage > 4 hours and > 6 hours
Timepoint [2] 3246 0
Timepoint for Outcome 2: Baseline, 1 month, 3 months, 6 months following intervention
Primary outcome [3] 3247 0
Primary Outcome 3: Neurocognitive function
Timepoint [3] 3247 0
Timepoint for Outcome 3: Baseline, 1 month, 6 months following intervention
Secondary outcome [1] 5410 0
Secondary Outcome 1: Mood (depression, anxiety, stress)
Timepoint [1] 5410 0
Timepoint for Outcome 1: Baseline, 1 month and 6 months following intervention
Secondary outcome [2] 5411 0
Secondary Outcome 2: Daytime sleep propensity
Timepoint [2] 5411 0
Timepoint for Outcome 2: Baseline, 1 month and 6 months following intervention

Eligibility
Key inclusion criteria
Diagnosis of Obstructive Sleep Apnea
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
An inability to communicate and understand written English.
Use of psychotropic drugs.
Previous trial of CPAP.

Study design
Purpose of the study
Educational / counselling / training
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Participants recruited from sleep clinics at the Royal Prince Alfred and Royal North Shore Hospitals, individuals who have been diagnosed with OSA following polysomnography and who have elected to undergo CPAP treatment will be invited to take part in the present study.
Consenting participants were randomised to in hospital CPAP titration or home autoCPAP titration. Allocation was concealed using sealed opaque envelopes which were opened following participant consent and prior to treatment as usual session.
Following treatment as usual for CPAP participants were randomised to CBT or Social Reciprocity (SR). Sealed opaque envelopes containing treatment allocation were opened following completion of treatment as usual.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
There are two randomisation components in this study. Both sequences are permuted block randomisation from a web based sequence programme.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
10/09/2007
Actual
1/11/2007
Date of last participant enrolment
Anticipated
Actual
3/08/2009
Date of last data collection
Anticipated
Actual
3/05/2010
Sample size
Target
220
Accrual to date
Final
206
Recruitment in Australia
Recruitment state(s)
NSW
Recruitment postcode(s) [1] 373 0
2050
Recruitment postcode(s) [2] 374 0
2065

Funding & Sponsors
Funding source category [1] 2508 0
Government body
Name [1] 2508 0
National Health and Medical Research Council
Country [1] 2508 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] 2277 0
University
Name [1] 2277 0
University of Sydney
Address [1] 2277 0
The University of Sydney
NSW 2006
Country [1] 2277 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 4423 0
Sydney South West Area Health Service Ethics Review Committee (RPAH Zone)
Ethics committee address [1] 4423 0
Main Quadrangle A14
The University of Sydney NSW 2006
Ethics committee country [1] 4423 0
Australia
Date submitted for ethics approval [1] 4423 0
Approval date [1] 4423 0
20/06/2007
Ethics approval number [1] 4423 0
10225

Summary
Brief summary
Obstructive Sleep Apnea (OSA) is a common sleep disorder which is commonly treated with Continuous Positive Airway Pressure (CPAP). Up to 50% of individuals either do not take their CPAP treatments home or are not using them at 6 months. Preliminary data from CPAP patients found significantly increased uptake and usage >4hours each night with a Cognitive behavioural therapy CBT) intervention. Our aim is to compare TAU with the addition of a CBT intervention to TAU with the addition of Social Reciprocity to determine the effectiveness of CBT in improving CPAP treatment acceptance and adherence in OSA sufferers
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 27985 0
Dr Delwyn Bartlett
Address 27985 0
Woolcock Institute of Medical Research PO Box M77 Missenden Road Camperdown NSW 2050
Country 27985 0
Australia
Phone 27985 0
+61 2 9515 5830
Fax 27985 0
Email 27985 0
[email protected]
Contact person for public queries
Name 11142 0
Ms Sarah Newton-John
Address 11142 0
Woolcock Institute of Medical Research
PO Box M77 Missenden Road
Camperdown NSW 2050
Country 11142 0
Australia
Phone 11142 0
61 2 9515 6578
Fax 11142 0
61 2 9550 5865
Email 11142 0
[email protected]
Contact person for scientific queries
Name 2070 0
Dr Delwyn Bartlett
Address 2070 0
Woolcock Institute of Medical Research
PO Box M77 Missenden Road
Camperdown NSW 2050
Country 2070 0
Australia
Phone 2070 0
61 2 9515 5830
Fax 2070 0
61 2 9515 7070
Email 2070 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
What data in particular will be shared?
Individual participant underlying published results only.
When will data be available (start and end dates)?
Data will be made available upon request, after publication, with no end date determined.
Available to whom?
Data will be made available upon request, after publication and will be determined upon negotiation with researchers who provided a methodologically sound proposal.
Available for what types of analyses?
Any purpose.
How or where can data be obtained?
Secure data transfer and signed data access agreement. Contact:[email protected]


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
TypeIs Peer Reviewed?DOICitations or Other DetailsAttachment
Study results articleYes Published: 01 November 2013 https://doi.org/10.566... [More Details]

Documents added automatically
No additional documents have been identified.