Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12606000065594
Ethics application status
Approved
Date submitted
14/02/2006
Date registered
15/02/2006
Date last updated
4/01/2011
Type of registration
Retrospectively registered

Titles & IDs
Public title
Increased Adherence to Continuous Positive Airway Pressure (CPAP) with a Group Cognitive Behavioural Treatment Intervention
Scientific title
Randomised Trial of Cognitive Behavioural Therapy to improve adherence to Continuous Positive Airway Pressure Treatment in patients with Obstructive Sleep Apnea Hypopnea Syndrome
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Obstructive Sleep Apnea Hypopnea Syndrome. 1028 0
Condition category
Condition code
Respiratory 1103 1103 0 0
Sleep apnoea

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Cognitive Behavioural Therapy (CBT) based on Social Cognitive Theory (SCT) Duration of the Intervention: Two 1 hour CBT sessions vs single 90 minute TAU session.
Intervention code [1] 894 0
None
Comparator / control treatment
Treatment as Usual (TAU) with standard education session
Control group
Active

Outcomes
Primary outcome [1] 1470 0
Adherence measured by hours of CPAP usage
Timepoint [1] 1470 0
At 28 days
Secondary outcome [1] 2636 0
Questionnaire data on self efficacy, social support and expectancy after interventions.
Timepoint [1] 2636 0
Secondary outcome [2] 2637 0
Adherence measured by hours of CPAP usage.
Timepoint [2] 2637 0
At 7 days.
Secondary outcome [3] 2638 0
Proportion using CPAP > 4 hours per night
Timepoint [3] 2638 0
At 7 and 28 days.

Eligibility
Key inclusion criteria
Patients with diagnosed obstructive sleep apnea referred for CPAP therapy.
Minimum age
18 Years
Maximum age
85 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Lack of fluency in spoken and written English.

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)
Sequentially-numbered, opaque sealed envelopes.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Computer generated randomization (the sample function in the statistical package R (www.r-project.org) in blocks, performed by a person not involved with subjects.
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



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

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
1/03/2005
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
100
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 1206 0
Self funded/Unfunded
Name [1] 1206 0
Country [1] 1206 0
Primary sponsor type
Individual
Name
Delwyn Bartlett
Address
Country
Secondary sponsor category [1] 1065 0
Individual
Name [1] 1065 0
Dianne Richards
Address [1] 1065 0
Country [1] 1065 0
Secondary sponsor category [2] 1066 0
Individual
Name [2] 1066 0
Ron Grunstein
Address [2] 1066 0
Country [2] 1066 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 2546 0
Royal North Shore Hospital-Northern Sydney Health Human Research Ethics Committee
Ethics committee address [1] 2546 0
Ethics committee country [1] 2546 0
Australia
Date submitted for ethics approval [1] 2546 0
Approval date [1] 2546 0
27/08/2004
Ethics approval number [1] 2546 0
0401-015M
Ethics committee name [2] 2547 0
Royal North Shore Hospital-University of New England
Ethics committee address [2] 2547 0
Ethics committee country [2] 2547 0
Australia
Date submitted for ethics approval [2] 2547 0
Approval date [2] 2547 0
11/11/2004
Ethics approval number [2] 2547 0
HE05/048

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

Contacts
Principal investigator
Name 36335 0
Address 36335 0
Country 36335 0
Phone 36335 0
Fax 36335 0
Email 36335 0
Contact person for public queries
Name 10083 0
Sarah Newton-John
Address 10083 0
Woolcock Institute of Medical Research
PO Box M77
Missenden Road
Camperdown NSW 2050
Country 10083 0
Australia
Phone 10083 0
+61 2 95156578
Fax 10083 0
+61 2 95155865
Email 10083 0
[email protected]
Contact person for scientific queries
Name 1011 0
Dr Delwyn Bartlett
Address 1011 0
PO Box M77
Missenden Road
Camperdown NSW 2050
Country 1011 0
Australia
Phone 1011 0
+61 2 95158530
Fax 1011 0
+61 2 95157070
Email 1011 0
[email protected]

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
TypeIs Peer Reviewed?DOICitations or Other DetailsAttachment
Study results articleYes Published: 01 May 2007 https://doi.org/10.1093/sle... [More Details]

Documents added automatically
SourceTitleYear of PublicationDOI
EmbaseImprovements in cognitive function and quantitative sleep electroencephalogram in obstructive sleep apnea after six months of continuous positive airway pressure treatment.2022https://dx.doi.org/10.1093/sleep/zsac013
N.B. These documents automatically identified may not have been verified by the study sponsor.