Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12608000054314
Ethics application status
Approved
Date submitted
25/11/2006
Date registered
29/01/2008
Date last updated
2/07/2012
Type of registration
Retrospectively registered

Titles & IDs
Public title
Comparison of 3 methods of continuous positive airway pressure titration for obstructive sleep apnoea
Scientific title
Manual laboratory continuous positive airway presssure (CPAP) titration compared to laboratory and home autotitration to assess compliance and clinical response among people with obstructive sleep apnoea
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Obstructive Sleep Apnoea 2119 0
Condition category
Condition code
Respiratory 2214 2214 0 0
Sleep apnoea

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
3 CPAP titration methods are compared in terms of clinical and physiological response to treatment at 1 month. Patients are randomised to a one of 3 different interventions. The intervention is one of 3 ways of determining the pressure for a patient's CPAP machine. This intervention occurs on the first night of treatment, i.e., during a night of sleep. The intervention compares one of 3 ways to determine the pressure or air needed during sleep to control obstructive sleep apnoea. The manual titration method involves a technologist monitoring the sleep of the patient while pressure is varied. The autotitration can be done in the laboratory or at home. The machine varies the pressure rather than the sleep technologist and provides a recommended pressure dependent on the changes in airflow as pressure is changed. In the laboratory autotitration the technologist can still help the patient if there are problems, eg a dry mouth, while pressure is applied. Assessments are made after one month on CPAP treatment at the pressure detemined above. Assessments are clinical questionnaire measures of sleepiness, quality of life, cognitive function and blood pressure are measured during the day and control of OSA is measured by monitoring during sleep in the sleep laboratory while on CPAP treatment.
Intervention code [1] 1467 0
Treatment: Devices
Comparator / control treatment
The control group is the manual CPAP titration group. This is considered the reference standard of CPAP titration.
Control group
Active

Outcomes
Primary outcome [1] 3067 0
CPAP compliance
Timepoint [1] 3067 0
1 month
Primary outcome [2] 3068 0
Change in Epworth Sleepiness Scale compared to before treatment
Timepoint [2] 3068 0
1 month
Secondary outcome [1] 5149 0
Quality of life (Short Form 36 questionnaire)
Timepoint [1] 5149 0
1 month
Secondary outcome [2] 5150 0
Control of sleep disordered breathing (apnoea/hypopnoea index on CPAP)
Timepoint [2] 5150 0
1 month

Eligibility
Key inclusion criteria
Symptoms of obstructive sleep apnoea that would respond to CPAP therapy, Apnoea/hypopnoea index>15, Epwortth Sleepiness Scale at least 8.
Minimum age
18 Years
Maximum age
75 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Body Mass Indes (BMI)>45kg/m2, Periodic leg movement index >15 events/hr slept, Predominant central sleep apnoea (>50% central apnoeas), Respiratory failure from any cause, Significant lung or heart disease, recent stroke, neuromuscular disease, Other severe medical illness or acutely unwell, Unable to comprehend the study, eg: because of language difficulties.

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)
sealed opaque envelopes
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Stratified randomisation (eligible for public funding of CPAP treatment or not), using a computerised random number generator
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
principal therapist (sleep physician reviewing patient, and determining the pressure from the titration night), assessor and data analyst
Phase
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Active, not recruiting
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
180
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
Recruitment postcode(s) [1] 746 0
6009

Funding & Sponsors
Funding source category [1] 2373 0
Other
Name [1] 2373 0
Western Australian Sleep Disorders Research Institute
Country [1] 2373 0
Australia
Funding source category [2] 3037 0
Commercial sector/Industry
Name [2] 3037 0
Res Med Ltd
Country [2] 3037 0
Australia
Primary sponsor type
Other
Name
Western Australian Sleep Disorders Institute
Address
Hospital Ave, Queen Elizabeth II Medical Centre, Nedlands. W.A. 6009
Country
Australia
Secondary sponsor category [1] 2149 0
Other
Name [1] 2149 0
Western Australian Sleep Disorders Research Institute
Address [1] 2149 0
Hospital Ave, Queen Elizabeth II Medical Centre, Nedlands. W.A. 6009
Country [1] 2149 0
Australia
Secondary sponsor category [2] 2738 0
None
Name [2] 2738 0
Address [2] 2738 0
Country [2] 2738 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 4197 0
Sir Charles Gairdner Hospital
Ethics committee address [1] 4197 0
Ethics committee country [1] 4197 0
Australia
Date submitted for ethics approval [1] 4197 0
Approval date [1] 4197 0
31/01/2005
Ethics approval number [1] 4197 0
2004-084
Ethics committee name [2] 4198 0
Western Australian Sleep Disorders Institute
Ethics committee address [2] 4198 0
Ethics committee country [2] 4198 0
Australia
Date submitted for ethics approval [2] 4198 0
Approval date [2] 4198 0
31/01/2005
Ethics approval number [2] 4198 0
2004-084

Summary
Brief summary
The best way of determining a CPAP pressure to control sleep apnoea is not known. We are comparing 3 common methods of determining this pressure and assessing the effect on the compliance with CPAP and response to therapy
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 27401 0
Address 27401 0
Country 27401 0
Phone 27401 0
Fax 27401 0
Email 27401 0
Contact person for public queries
Name 10656 0
Nigel McArdle
Address 10656 0
Western Australian Sleep Disorders Research Institute
Sir Charles Gairdner Hospital
Hospital Ave
Nedlands WA
Country 10656 0
Australia
Phone 10656 0
08 93462422
Fax 10656 0
08 93462822
Email 10656 0
Nigel.McArdle@health.wa.gov.au
Contact person for scientific queries
Name 1584 0
Nigel McArdle
Address 1584 0
Western Australian Sleep Disorders Research Institute
Sir Charles Gairdner Hospital
Hospital Ave
Nedlands WA
Country 1584 0
Australia
Phone 1584 0
08 93462422
Fax 1584 0
08 93462822
Email 1584 0
Nigel.McArdle@health.wa.gov.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
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Documents added automatically
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