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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?
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
Secondary ID [1] 259729 0
Nil
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Obstructive Sleep Apnoea 261309 0
Condition category
Condition code
Respiratory 259459 259459 0 0
Sleep apnoea

Intervention/exposure
Study type
Interventional
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
Intervention code [1] 264158 0
Treatment: Devices
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.
Control group
Uncontrolled

Outcomes
Primary outcome [1] 262270 0
Therapeutic pressure (determined by auto-adjusting device), flow, leak, full PSG with each of the two masks
Timepoint [1] 262270 0
One night for each of the masks.
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)
Timepoint [2] 262271 0
One night for each of the masks.
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
Timepoint [3] 262272 0
One night for each of the two studies.
Secondary outcome [1] 273434 0
Nil
Timepoint [1] 273434 0
Nil

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
Minimum age
No limit
Maximum age
No limit
Gender
Both males and females
Can healthy volunteers participate?
No
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

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)
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.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Computer generated first night mask choice.
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



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

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

Funding & Sponsors
Funding source category [1] 264607 0
Self funded/Unfunded
Name [1] 264607 0
Ludwig Edgar Centre for Respiratory Research
Address [1] 264607 0
LECRR
Department of Respiratory Medicine
Westmead Hospital
PO Box 533
WENTWORTHVILLE NSW 2145
Country [1] 264607 0
Australia
Primary sponsor type
Individual
Name
Professor John Wheatley
Address
LECRR
Department of Respiratory
Westmead Hospital
PO Box 533
WENTWORTHVILLE NSW 2145
Country
Australia
Secondary sponsor category [1] 263753 0
None
Name [1] 263753 0
Address [1] 263753 0
Country [1] 263753 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 260607 0
Sydney West Area Health Service Human Research Ethics Committee
Ethics committee address [1] 260607 0
Sydney West Area Health Service Human Research Ethics Committee
PO Box 533
WENTWORTHVILLE NSW 2145
Ethics committee country [1] 260607 0
Australia
Date submitted for ethics approval [1] 260607 0
Approval date [1] 260607 0
03/09/2008
Ethics approval number [1] 260607 0
08/WESTMEAD/153

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.
Trial website
Nil
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
Public notes

Contacts
Principal investigator
Name 32264 0
Address 32264 0
Country 32264 0
Phone 32264 0
Fax 32264 0
Email 32264 0
Contact person for public queries
Name 15511 0
Professor John Wheatley MB BS (Hons) PhD FRACP
Address 15511 0
Professor John Wheatley
Director Department of Respiratory and Sleep Medicine
Westmead Hospital
PO Box 533
WENTWORTHVILLE NSW 2145
Country 15511 0
Australia
Phone 15511 0
+61 2 9845 6797
Fax 15511 0
+61 2 9845 7286
Email 15511 0
john_wheatley@wmi.usyd.edu.au
Contact person for scientific queries
Name 6439 0
Professor John Wheatley MB BS (Hons) PhD FRACP
Address 6439 0
Professor John Wheatley
Director Department of Respiratory and Sleep Medicine
Westmead Hospital
PO Box 533
WENTWORTHVILLE NSW 2145
Country 6439 0
Australia
Phone 6439 0
+61 2 9845 6797
Fax 6439 0
+61 2 9845 7286
Email 6439 0
john_wheatley@wmi.usyd.edu.au

No information has been provided regarding IPD availability
Summary results
Have study results been published in a peer-reviewed journal?
Other publications
Have study results been made publicly available in another format?
Results – basic reporting
Results – plain English summary