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
ACTRN12611000409976
Ethics application status
Not yet submitted
Date submitted
18/04/2011
Date registered
19/04/2011
Date last updated
6/06/2011
Type of registration
Prospectively registered

Titles & IDs
Public title
Multimodal phenotyping for the prediction of oral appliance treatment outcome in obstructive sleep apnoea
Scientific title
Multimodal phenotyping for the prediction of oral appliance treatment outcome in obstructive sleep apnoea
Secondary ID [1] 259777 0
Nil
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Obstructive sleep apnoea 261361 0
Condition category
Condition code
Respiratory 259520 259520 0 0
Sleep apnoea

Intervention/exposure
Study type
Observational
Patient registry
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
A mandibular advancement splint will be used by participants in the study. The splint itself is not under examination in this study, but is being used to determine patient characteristics that predict treatment outcome.
A fully adjustable two-piece splint MAS will be used (SomnoDent, SomnoMed Ltd) with known high efficacy will be used. Fitting of the appliance is followed by an acclimatisation period (4-8 weeks) during which the mandible is incrementally advanced until the maximum comfortable limit is reached (under the supervision of the treating dentist).
Participants will be recruited for approximately 2 years and will be observed during the study for 4-8 weeks. They will be referred back to their own sleep physician and dentist for continuation of their treatment.
Intervention code [1] 264212 0
Not applicable
Comparator / control treatment
No comparator/control treatment
Control group
Uncontrolled

Outcomes
Primary outcome [1] 266576 0
To use multimodal assessments of upper airway sleep and awake structure and function to extensively phenotype OSA patients selected for MAS treatment.
Timepoint [1] 266576 0
End of study
Secondary outcome [1] 276048 0
To determine which phenotypic traits from each assessment relate to MAS treatment outcome and the inter-relationships between them.
Timepoint [1] 276048 0
End of study
Secondary outcome [2] 276049 0
To use the findings of multimodal phenotyping to develop an accurate composite prediction model for MAS treatment outcome using the minimum number of assessments necessary.
Timepoint [2] 276049 0
End of study
Secondary outcome [3] 276050 0
To prospectively validate the derived prediction model.
Timepoint [3] 276050 0
End of study

Eligibility
Key inclusion criteria
1. Age greater than 18 years
2. OSA defined by polysomnography (AHI >10 /hour)
3. A clinical decision to undertake oral appliance treatment
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
1. Central sleep apnoea
2. Need for immediate therapy (eg. sleepy drivers)
3. Co-existing sleep disorder (eg. narcolepsy, shift work)
4. Contraindications to oral appliance therapy (periodontal disease or dental caries, less than 10 teeth per dental arch, exaggerated gag reflex)
5. Regular use of sedatives, narcotics, or psychoactive drugs
6. Pregnant or breastfeeding women

Study design
Purpose
Screening
Duration
Cross-sectional
Selection
Defined population
Timing
Prospective
Statistical methods / analysis

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
31/05/2011
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
200
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
Recruitment postcode(s) [1] 3929 0
2065
Recruitment postcode(s) [2] 3930 0
2037

Funding & Sponsors
Funding source category [1] 264911 0
University
Name [1] 264911 0
University of Sydney
Country [1] 264911 0
Australia
Primary sponsor type
University
Name
University of Sydney
Address
University Road
Camperdown
NSW
2006
Country
Australia
Secondary sponsor category [1] 264012 0
None
Name [1] 264012 0
Address [1] 264012 0
Country [1] 264012 0

Ethics approval
Ethics application status
Not yet submitted
Ethics committee name [1] 266871 0
Sydney South West Area Health Service Human Research Ethics Committe (RPAH Zone) EC00113
Ethics committee address [1] 266871 0
Research Development Office
Royal Prince Alfred Hospital
Missenden Road
Camperdown
NSW 2050
Ethics committee country [1] 266871 0
Australia
Date submitted for ethics approval [1] 266871 0
27/04/2010
Approval date [1] 266871 0
Ethics approval number [1] 266871 0

Summary
Brief summary
Obstructive sleep apnoea is a common sleep-related breathing disorder. Oral appliances worn during sleep to gently hold the lower jaw in a forward position are a novel treatment often appealing to patients. Currently use is limited as there is no means to determine if patients will be treated successfully. There is a need for simple, clinical methods to predict which patients are best suited to this new treatment approach and this project will address this by developing such a method.
This study will use a combination of data measured from patients with obstructive sleep apnoea including sleep characteristics, lung function and facial dimension measured from photographs to produce a virtual model to predict whether or not a patient will respond to treatment with an oral appliance.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 32341 0
Address 32341 0
Country 32341 0
Phone 32341 0
Fax 32341 0
Email 32341 0
Contact person for public queries
Name 15588 0
Prof Peter Cistulli
Address 15588 0
Centre for Sleep Health and Research
Level 8
Royal North Shore Hospital
St Leonards
NSW 2065
Country 15588 0
Australia
Phone 15588 0
+61 2 9926 8673
Fax 15588 0
+61 2 9906 6391
Email 15588 0
[email protected]
Contact person for scientific queries
Name 6516 0
Prof Peter Cistulli
Address 6516 0
Centre for Sleep Health and Research
Level 8
Royal North Shore Hospital
St Leonards
NSW 2065
Country 6516 0
Australia
Phone 6516 0
+61 2 9926 8673
Fax 6516 0
+61 2 9906 6391
Email 6516 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
EmbaseUpper airway morphology in adults with positional obstructive sleep apnea.2023https://dx.doi.org/10.1007/s11325-023-02879-0
N.B. These documents automatically identified may not have been verified by the study sponsor.