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
Trial registered on ANZCTR


Registration number
ACTRN12607000289415
Ethics application status
Approved
Date submitted
15/05/2007
Date registered
31/05/2007
Date last updated
9/11/2015
Type of registration
Prospectively registered

Titles & IDs
Public title
Randomised controlled trial of the effect of mandibular advancement splint (MAS) versus positive airway pressure (PAP) therapy on blood pressure in obstructive sleep apnoea
Scientific title
Randomised controlled trial of the effect of mandibular advancement splint (MAS) versus positive airway pressure (PAP) therapy on blood pressure in obstructive sleep apnoea
Secondary ID [1] 262252 0
Nil
Universal Trial Number (UTN)
Trial acronym
MASPAP
Linked study record

Health condition
Health condition(s) or problem(s) studied:
obstructive sleep apnoea 1831 0
Condition category
Condition code
Respiratory 1923 1923 0 0
Chronic obstructive pulmonary disease

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The study will compare the gold standard treatment for Obstructive Sleep Apnoea, namely Continuous Positive Airway Pressure (CPAP), to oral appliance therapy. CPAP treatment involves the delivery of pressurised air from a pump to the nose via tubing and a nose mask. The pressurised air acts to prevent the airway from collapsing during sleep. Oral appliance therapy involves a titratable intra-oral device worn during sleep, that advances the mandible to improve upper airway calibre and function. The oral appliance being used is a Mandibular Advancement Splint (MAS). Following appropriate acclimatisation to both treatment modalities, patients will undergo 1 month intervention with each treatment (cross-over design) in order to compare the health effects of the treatments. Subjects will be encouraged to use each device every night during sleep. Following treatment on the first device, there will be a 2 week washout period before subjects are crossed over to the second device.
Intervention code [1] 1759 0
Treatment: Devices
Comparator / control treatment
Continuous Positive Airway Pressure (CPAP)
Control group
Active

Outcomes
Primary outcome [1] 2736 0
24 hour mean arterial blood pressure (MAP)
Timepoint [1] 2736 0
At 1 month after the use of CPAP and at 1 month after the use of Mandibular Advancement Splint.
Secondary outcome [1] 4612 0
24 hr Systolic (SBP) and Diastolic (DBP) blood pressures
Timepoint [1] 4612 0
Assessed at 1 month after the use of CPAP and at 1 month after the use of the Mandibular Advancement Splint.
Secondary outcome [2] 4613 0
Mean Waking and Sleeping blood pressures - Mean Arterial Pressure (MAP), SBP and DBP
Timepoint [2] 4613 0
Assessed at 1 month after the use of CPAP and at 1 month after the use of the Mandibular Advancement Splint.
Secondary outcome [3] 4614 0
Central blood pressure (Central SBP and Augmentation Index)
Timepoint [3] 4614 0
Assessed at 1 month after the use of CPAP and at 1 month after the use of the Mandibular Advancement Splint.
Secondary outcome [4] 4615 0
Driving simulator performance (AusEd)
Timepoint [4] 4615 0
Assessed at 1 month after the use of CPAP and at 1 month after the use of the Mandibular Advancement Splint.
Secondary outcome [5] 4616 0
Polysomnographic measures of treatment efficacy at the end of each 1 month treatment period (Apnoea Hypopnoea Index (AHI), Minimum Oxygen Saturation, Arousal Index)
Timepoint [5] 4616 0
Assessed at 1 month after the use of CPAP and at 1 month after the use of the Mandibular Advancement Splint.
Secondary outcome [6] 4617 0
Quality of life (SF-36, Functional Outcomes of Sleep Questionnaire (FOSQ))
Timepoint [6] 4617 0
Assessed at 1 month after the use of CPAP and at 1 month after the use of the Mandibular Advancement Splint.
Secondary outcome [7] 4618 0
Subjective Daytime Sleepiness (Epworth Sleepiness Scale)
Timepoint [7] 4618 0
Assessed at 1 month after the use of CPAP and at 1 month after the use of the Mandibular Advancement Splint.
Secondary outcome [8] 4619 0
Compliance
Timepoint [8] 4619 0
Assessed at 1 month after the use of CPAP and at 1 month after the use of the Mandibular Advancement Splint.
Secondary outcome [9] 4620 0
Side-effects (nature and frequency)
Timepoint [9] 4620 0
Reported by questionnaire at the end of each 1 month treatment period

Eligibility
Key inclusion criteria
Presence of at least 2 symptoms of obstructive sleep apnoea (snoring, fragmented sleep, witnessed apneas, daytime sleepiness); proven obstructive sleep apnoea on polysomnography (AHI>10)
Minimum age
20 Years
Maximum age
Not stated
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Previous treatment of Obstuctive Sleep Apnoea; central sleep apnea, need for immediate treatment, co-existing sleep disorder, contraindications to oral appliance therapy, regular use of sedatives or narcotics, pre-existing lung disease, active psychiatric disease

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 envelopes
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Random Permuted Blocks generated by computer program
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Crossover
Other design features
Phase
Phase 3 / Phase 4
Type of endpoint/s
Bio-equivalence
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
8/06/2007
Actual
Date of last participant enrolment
Anticipated
Actual
22/12/2010
Date of last data collection
Anticipated
Actual
Sample size
Target
108
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW
Recruitment hospital [1] 4595 0
Royal North Shore Hospital - St Leonards
Recruitment hospital [2] 4596 0
Royal Prince Alfred Hospital - Camperdown

Funding & Sponsors
Funding source category [1] 2068 0
Government body
Name [1] 2068 0
National Health & Medical Research Council of Australia (Project grant 457557)
Country [1] 2068 0
Australia
Primary sponsor type
Other
Name
Woolcock Institute of Medical Research
Address
PO BOX M77, Missenden Road NSW 2050
Country
Australia
Secondary sponsor category [1] 1873 0
University
Name [1] 1873 0
University of Sydney
Address [1] 1873 0
University of Sydney, NSW 2006
Country [1] 1873 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 3840 0
Northern Sydney Central Coast Area Health Service
Ethics committee address [1] 3840 0
Ethics committee country [1] 3840 0
Australia
Date submitted for ethics approval [1] 3840 0
Approval date [1] 3840 0
28/11/2006
Ethics approval number [1] 3840 0
0610-192M
Ethics committee name [2] 3841 0
University of Sydney
Ethics committee address [2] 3841 0
Ethics committee country [2] 3841 0
Australia
Date submitted for ethics approval [2] 3841 0
Approval date [2] 3841 0
15/12/2006
Ethics approval number [2] 3841 0
9778
Ethics committee name [3] 3842 0
Sydney South West Area Health Service
Ethics committee address [3] 3842 0
Ethics committee country [3] 3842 0
Australia
Date submitted for ethics approval [3] 3842 0
Approval date [3] 3842 0
Ethics approval number [3] 3842 0

Summary
Brief summary
The broad aim of the project is to compare MAS and CPAP treatment in patients with Obstructive Sleep Apnoea to test the hypothesis that these treatments have equivalent health effects in terms of important clinical outcomes as a result of the superior efficacy of CPAP being offset by lower treatment compliance than MAS.
Trial website
Trial related presentations / publications
Health outcomes of continuous positive airway pressure versus oral appliance treatment for obstructive sleep apnea: a randomized controlled trial. Am J Respir Crit Care Med. 2013 Apr 15;187(8):879-87.
Public notes

Contacts
Principal investigator
Name 27862 0
Prof Peter Cistulli
Address 27862 0
Department of Respiratory & Sleep Medicine
Royal North Shore Hospital
St Leonards
NSW 2065
Country 27862 0
Australia
Phone 27862 0
0294632920
Fax 27862 0
Email 27862 0
[email protected]
Contact person for public queries
Name 10948 0
Mrs
Address 10948 0
Woolcock Institute of Medical Research
PO Box M77
Missenden Road
Camperdown NSW 2050
Country 10948 0
Australia
Phone 10948 0
+61 2 95155678
Fax 10948 0
+61 2 95505865
Email 10948 0
[email protected]
Contact person for scientific queries
Name 1876 0
Dr
Address 1876 0
Woolcock Institute of Medical Research
Level 7 Building 14 Royal Prince Alfred Hospital
Missenden Road
Camperdown NSW 2050
Country 1876 0
Australia
Phone 1876 0
+61 2 95156417
Fax 1876 0
+61 2 95575059
Email 1876 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
No documents have been uploaded by study researchers.

Documents added automatically
SourceTitleYear of PublicationDOI
EmbaseHealth outcomes of continuous positive airway pressure versus oral appliance treatment for obstructive sleep apnea: A randomized controlled trial.2013https://dx.doi.org/10.1164/rccm.201212-2223OC
EmbaseHealth outcomes of continuous positive airway pressure versus mandibular advancement device for the treatment of severe obstructive sleep apnea: An individual participant data meta-analysis.2021https://dx.doi.org/10.1093/sleep/zsab015
Dimensions AISleep Apnea Cardiovascular Clinical Trials—Current Status and Steps Forward: The International Collaboration of Sleep Apnea Cardiovascular Trialists2013https://doi.org/10.5665/sleep.2790
N.B. These documents automatically identified may not have been verified by the study sponsor.