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Multimodal phenotyping for the prediction of oral appliance treatment outcome in obstructive sleep apnoea

Multimodal phenotyping for the prediction of oral appliance treatment outcome in obstructive sleep apnoea

Status
Not yet recruiting
Phases
Unknown
Study type
Observational
Source
ANZCTR
Registry ID
ACTRN12611000409976
Enrollment
200
Registered
2011-04-19
Start date
2011-05-31
Completion date
Unknown
Last updated
2020-01-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

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.

Interventions

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 li

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.

Sponsors

University of Sydney
Lead SponsorUniversity

Eligibility

Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
No

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

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

Outcome results

None listed

Source: ANZCTR · Data processed: Mar 5, 2026