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

Not Applicable

• Conditions: Obstructive sleep apnoea; Respiratory - Sleep apnoea

• Registration Number: ACTRN12611000409976
• Lead Sponsor: niversity of Sydney

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2011-04-19
• Last Update Posted: 13 January 2020

Recruitment & Eligibility

• Status: ot yet recruiting
• Sex: All
• Target Recruitment: 200

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

Study & Design

• Study Type: Observational
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
To use multimodal assessments of upper airway sleep and awake structure and function to extensively phenotype OSA patients selected for MAS treatment.[End of study]

Secondary Outcome Measures

Name	Time	Method
To determine which phenotypic traits from each assessment relate to MAS treatment outcome and the inter-relationships between them.[End of study];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.[End of study];To prospectively validate the derived prediction model.[End of study]