Please note that the copy function is not enabled for this field.
If you wish to
modify
existing outcomes, please copy and paste the current outcome text into the Update field.
LOGIN
CREATE ACCOUNT
LOGIN
CREATE ACCOUNT
MY TRIALS
REGISTER TRIAL
FAQs
HINTS AND TIPS
DEFINITIONS
Trial Review
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this
information for consumers
Download to PDF
Trial registered on ANZCTR
Registration number
ACTRN12611000243910
Ethics application status
Approved
Date submitted
4/03/2011
Date registered
4/03/2011
Date last updated
22/08/2017
Type of registration
Retrospectively registered
Titles & IDs
Public title
Does the type of continuous positive airway pressure mask (full face or nasal) effect the required therapeutic pressure and patient preference in patients with obstructive sleep apnea?
Query!
Scientific title
A comparison of nasal and full-face masks in patients with obstructive sleep apnoea prescribed continuous positive airway pressure therapy: required therapy pressure, comfort and mask preference
Query!
Secondary ID [1]
259729
0
Nil
Query!
Universal Trial Number (UTN)
Query!
Trial acronym
Query!
Linked study record
Query!
Health condition
Health condition(s) or problem(s) studied:
Obstructive Sleep Apnoea
261309
0
Query!
Condition category
Condition code
Respiratory
259459
259459
0
0
Query!
Sleep apnoea
Query!
Intervention/exposure
Study type
Interventional
Query!
Description of intervention(s) / exposure
Subjects will be randomised to either a nasal or an oronasal mask with the alternate mask style to be used on the second night. A chin strap will be used in conjunction with nasal mask.
Mask interfaces for continuous positive airway pressure (CPAP) for obstructive sleep cover the patient's nose (nasal mask) or nose and mouth (oronasal mask). The chin strap gently supports the jaw so the mouth is closed when using a nasal mask.
Continuous positive air pressure (CPAP) was automatically titrated by an autotitrating CPAP machine on both nights for the total sleep time of the patient
Query!
Intervention code [1]
264158
0
Treatment: Devices
Query!
Comparator / control treatment
Subjects will be randomised to either a nasal or oro-nasal mask with the alternate mask used on the second night. A chin strap will also be used on the nasal night to reduce the occurence of mouth leak.
Query!
Control group
Uncontrolled
Query!
Outcomes
Primary outcome [1]
262270
0
Therapeutic pressure (determined by auto-adjusting device), flow, leak, full PSG with each of the two masks
Query!
Assessment method [1]
262270
0
Query!
Timepoint [1]
262270
0
One night for each of the masks.
Query!
Primary outcome [2]
262271
0
On the morning following each CPAP study subjects relate by means of questionnaire their subjective perception of sleep quality, mask comfort and fit, mouth dryness and overall satisfaction with each mask using analogue scale (0=poorest, 10=best)
Query!
Assessment method [2]
262271
0
Query!
Timepoint [2]
262271
0
One night for each of the masks.
Query!
Primary outcome [3]
262272
0
Calulation of the respiratory disturbance index, arousal index, sleep efficiency, total sleep time, wake after sleep onset time and time spent in each sleep stage after review of polysomnogram by one sleep technician
Query!
Assessment method [3]
262272
0
Query!
Timepoint [3]
262272
0
One night for each of the two studies.
Query!
Secondary outcome [1]
273434
0
Nil
Query!
Assessment method [1]
273434
0
Query!
Timepoint [1]
273434
0
Nil
Query!
Eligibility
Key inclusion criteria
CPAP naive subjects with obstructive sleep apnea syndrome
Referral from sleep laboratory in a university hospital for CPAP titration
Respiratory Disturbance Index >15
Query!
Minimum age
No limit
Query!
Query!
Maximum age
No limit
Query!
Query!
Sex
Both males and females
Query!
Can healthy volunteers participate?
No
Query!
Key exclusion criteria
Previous oronasal operations
History of clinically severe nasal or sinus disease
Complex sleep disorded breathing
Significant comorbid respiratory disease
Significant comorbid cardiac disease
Orofacial problems precluding the use of a nasal or oronasal mask
Query!
Study design
Purpose of the study
Treatment
Query!
Allocation to intervention
Randomised controlled trial
Query!
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Subjects were recruited prospectively from CPAP titration referalls from a universtiy hospital. After giving written consent, the subject was randomised to receive either nasal or oronasal mask in the first instance then the alternate mask on the second study night. Mask allocation was concealed using central radomisation by computer.
Query!
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Computer generated first night mask choice.
Query!
Masking / blinding
Open (masking not used)
Query!
Who is / are masked / blinded?
Query!
Query!
Query!
Query!
Intervention assignment
Crossover
Query!
Other design features
Query!
Phase
Not Applicable
Query!
Type of endpoint/s
Efficacy
Query!
Statistical methods / analysis
Query!
Recruitment
Recruitment status
Completed
Query!
Date of first participant enrolment
Anticipated
3/09/2008
Query!
Actual
Query!
Date of last participant enrolment
Anticipated
Query!
Actual
Query!
Date of last data collection
Anticipated
Query!
Actual
Query!
Sample size
Target
24
Query!
Accrual to date
Query!
Final
Query!
Recruitment in Australia
Recruitment state(s)
Query!
Funding & Sponsors
Funding source category [1]
264607
0
Self funded/Unfunded
Query!
Name [1]
264607
0
Ludwig Edgar Centre for Respiratory Research
Query!
Address [1]
264607
0
LECRR
Department of Respiratory Medicine
Westmead Hospital
PO Box 533
WENTWORTHVILLE NSW 2145
Query!
Country [1]
264607
0
Australia
Query!
Primary sponsor type
Individual
Query!
Name
Professor John Wheatley
Query!
Address
LECRR
Department of Respiratory
Westmead Hospital
PO Box 533
WENTWORTHVILLE NSW 2145
Query!
Country
Australia
Query!
Secondary sponsor category [1]
263753
0
None
Query!
Name [1]
263753
0
Query!
Address [1]
263753
0
Query!
Country [1]
263753
0
Query!
Ethics approval
Ethics application status
Approved
Query!
Ethics committee name [1]
260607
0
Sydney West Area Health Service Human Research Ethics Committee
Query!
Ethics committee address [1]
260607
0
Sydney West Area Health Service Human Research Ethics Committee
PO Box 533
WENTWORTHVILLE NSW 2145
Query!
Ethics committee country [1]
260607
0
Australia
Query!
Date submitted for ethics approval [1]
260607
0
Query!
Approval date [1]
260607
0
03/09/2008
Query!
Ethics approval number [1]
260607
0
08/WESTMEAD/153
Query!
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. Titration studies are commonly performed using a nasal mask but some patients may prefer a full-face or oronasal mask. This study looks at therpeutic pressures for full-face and nasal masks and patient preferences.
Query!
Trial website
Nil
Query!
Trial related presentations / publications
Nasal verses Oro-Nasal Masks for OSA Treatment - CPAP pressures and Patient Preferences - Poster Presentation Melbourne ASA-ASTA Sleep Conference Nov 2009
Query!
Public notes
Query!
Contacts
Principal investigator
Name
32264
0
Query!
Address
32264
0
Query!
Country
32264
0
Query!
Phone
32264
0
Query!
Fax
32264
0
Query!
Email
32264
0
Query!
Contact person for public queries
Name
15511
0
Professor John Wheatley MB BS (Hons) PhD FRACP
Query!
Address
15511
0
Professor John Wheatley
Director Department of Respiratory and Sleep Medicine
Westmead Hospital
PO Box 533
WENTWORTHVILLE NSW 2145
Query!
Country
15511
0
Australia
Query!
Phone
15511
0
+61 2 9845 6797
Query!
Fax
15511
0
+61 2 9845 7286
Query!
Email
15511
0
[email protected]
Query!
Contact person for scientific queries
Name
6439
0
Professor John Wheatley MB BS (Hons) PhD FRACP
Query!
Address
6439
0
Professor John Wheatley
Director Department of Respiratory and Sleep Medicine
Westmead Hospital
PO Box 533
WENTWORTHVILLE NSW 2145
Query!
Country
6439
0
Australia
Query!
Phone
6439
0
+61 2 9845 6797
Query!
Fax
6439
0
+61 2 9845 7286
Query!
Email
6439
0
[email protected]
Query!
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
No documents have been uploaded by study researchers.
Documents added automatically
Source
Title
Year of Publication
DOI
Embase
Equivalence of nasal and oronasal masks during initial CPAP titration for obstructive sleep apnea syndrome.
2011
https://dx.doi.org/10.5665/SLEEP.1134
N.B. These documents automatically identified may not have been verified by the study sponsor.
Download to PDF