Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12610000583044
Ethics application status
Approved
Date submitted
20/07/2010
Date registered
20/07/2010
Date last updated
4/03/2014
Type of registration
Prospectively registered

Titles & IDs
Public title
Does the type of continuous positive airway pressure interface effect the required therapeutic pressure in patients with obstructive sleep apnoea?
Scientific title
A comparison of nasal and full-face masks in patients with obstructive sleep apnoea prescribed continuous positive airway pressure therapy: required therapeutic pressure and residual disease.
Secondary ID [1] 252245 0
None
Universal Trial Number (UTN)
U1111-1116-1380
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Obstructive sleep apnoea 257764 0
Condition category
Condition code
Respiratory 257939 257939 0 0
Sleep apnoea

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Patients will be assigned a standard full-face mask and an under-chin full-face mask (two interventions).

Mask interfaces for continuous positive airway pressure (CPAP) for obstructive sleep apnoea (OSA) can cover the patient's nose, mouth or both. A standard full-face mask forms a seal from the bridge of the nose to just underneath the lower lip. An under-chin full-face mask is larger, and forms a seal from the bridge of the nose to underneath the lower jaw.

Each mask will be worn for two consecutive nights, for as long as the patient is asleep (at least four hours per night).

There will be no washout between the three arms.
Intervention code [1] 256824 0
Treatment: Devices
Comparator / control treatment
Patients will be assigned a standard nasal cushion mask as control.

A standard nasal cushion mask forms a seal from the bridge of the nose to the upper lip (i.e. covers the nose only). For most patients, this type of mask is the first one tried, and a switch to an alternative (full-face) mask will only occur if this mask type does not fit standard criteria for an air-tight, comfortable seal.

This mask will be worn for two consecutive nights, for as long as the patient is asleep (at least four hours per night).
Control group
Active

Outcomes
Primary outcome [1] 258806 0
Therapeutic pressure (measured using an auto-adjusting device) required with each of the three masks.
Timepoint [1] 258806 0
Averaged over two nights of each mask.
Secondary outcome [1] 264869 0
Residual apnoea-hypopnoea index (AHI) with each of the three masks (delivered using standard CPAP set to manually titrated pressure).
Timepoint [1] 264869 0
Averaged over two nights of each mask.

Eligibility
Key inclusion criteria
Adult (greater than or equal to 25 years)
Moderate/severe OSA at baseline (AHI greater than or equal to 30)
Compliant with CPAP (using treatment greater than or equal to 4 hours per night on average)
Currently using a standard nasal cushion mask without chinstrap
Subjectively report predominant supine sleep
Minimum age
25 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Complete upper and/or lower denture
Excessive alcohol or caffeine intake
Significant cardiac, respiratory or sleep co-morbidity
Unwilling to restrict alcohol intake to less than or equal to 2 standard drinks per day for the trial duration.

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)
Patients will be recruited retrospectively, randomly from an established research database. After giving written informed consent, the patient will be randomised to receive the three mask types.

Allocation concealment will be carried out using sealed opaque envelopes.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
A random number generator will be used to determine the sequence of mask usage.
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Crossover
Other design features
No washout period.
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
15/08/2010
Actual
9/09/2010
Date of last participant enrolment
Anticipated
17/11/2010
Actual
17/11/2010
Date of last data collection
Anticipated
Actual
Sample size
Target
12
Accrual to date
Final
Recruitment outside Australia
Country [1] 2771 0
New Zealand
State/province [1] 2771 0
Wellington

Funding & Sponsors
Funding source category [1] 257298 0
University
Name [1] 257298 0
University of Otago
Country [1] 257298 0
New Zealand
Primary sponsor type
University
Name
University of Otago
Address
Department of Medicine
PO Box 7343
Wellington 6242
Country
New Zealand
Secondary sponsor category [1] 256541 0
None
Name [1] 256541 0
Address [1] 256541 0
Country [1] 256541 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 259326 0
Central Ethics Committee
Ethics committee address [1] 259326 0
1-3 The Terrace
2nd Floor
Wellington 5013
Ethics committee country [1] 259326 0
New Zealand
Date submitted for ethics approval [1] 259326 0
27/05/2010
Approval date [1] 259326 0
28/07/2010
Ethics approval number [1] 259326 0

Summary
Brief summary
When patients are established on CPAP treatment, they must first undergo a titration study of some description which determines the pressure required to hold the upper airway open. Most patients are assigned a nasal mask in the first instance, and will be swapped to a full-face mask if the nasal mask is not tolerated or does not form an adequate airtight seal. We have noted in our laboratory that standard full-face masks require higher therapeutic pressures than nasal masks, and think this may because a standard full-face mask places pressure on the lower jaw, pushing it back and narrowing the upper airway. We therefore aim to test the hypothesis that masks which seal over the nose only, or full-face masks that seal underneath the chin, require a similar therapeutic pressure which is significantly lower than that required with a standard full-face mask.
Trial website
Trial related presentations / publications
Bakker, J.P., Neill, A.M., Campbell, A.J. Nasal versus oronasal continuous positive airway pressure masks for obstructive sleep apnea: a pilot investigation of pressure requirement, residual disease and leak. Sleep & Breathing 16(3):709-716 (2012), PubMed ID 21800222;

Bakker, J.P., Neill, A.M., Campbell, A.J. Nasal versus oronasal continuous positive airway pressure masks for obstructive sleep apnea: Is this really a key point of effectiveness? [letter]. Sleep & Breathing 17(4):1123-1124 (2013), PubMed ID 23572436.
Public notes

Contacts
Principal investigator
Name 31405 0
A/Prof Alister Neill
Address 31405 0
University of Otago Department of Medicine PO Box 7343 Wellington 6242
Country 31405 0
New Zealand
Phone 31405 0
+6449208819
Fax 31405 0
Email 31405 0
alister.neill@otago.ac.nz
Contact person for public queries
Name 14652 0
Dr Jessie Bakker
Address 14652 0
University of Otago
Department of Medicine
PO Box 7343
Wellington 6242
Country 14652 0
New Zealand
Phone 14652 0
+6449208819
Fax 14652 0
Email 14652 0
jessie.bakker@otago.ac.nz
Contact person for scientific queries
Name 5580 0
Dr Jessie Bakker
Address 5580 0
University of Otago
Department of Medicine
PO Box 7343
Wellington 6242
Country 5580 0
New Zealand
Phone 5580 0
+6449208819
Fax 5580 0
Email 5580 0
jessie.bakker@otago.ac.nz

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No Supporting Document Provided



Results publications and other study-related documents

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