ACTRN12615000037505
Not yet recruiting
未知
An Open Label, Non-randomised study to evaluate the safety, efficacy, tolerability and compliance of the Tongue Tamer Mandibular Advancement Splint in patients with Obstructive Sleep Apnoea
Prof. Peter Cistulli0 sites15 target enrollmentJanuary 19, 2015
Overview
- Phase
- 未知
- Intervention
- Not specified
- Conditions
- Obstructive Sleep Apnoea
- Sponsor
- Prof. Peter Cistulli
- Enrollment
- 15
- Status
- Not yet recruiting
- Last Updated
- 6 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •1\. Age greater than 18 years
- •2\. Partial response to SomnoMed MAS, with residual moderate\- severe OSA defined by polysomnograph (AHI greater than 15\)
- •3\. Tolerance and compliance (greater than 4 hours use per night) to MAS treatment
- •4\. A clinical decision to undertake oral appliance treatment
- •5\. Fluency in both written and spoken English
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, dental caries, less than 10 teeth per dental arch, exaggerated gag reflex)
- •5\. Regular use of sedatives, narcotics, or psychoactive drugs
- •6\. Pregnant or breast feeding women
- •7\. Inability to understand English
Outcomes
Primary Outcomes
Not specified
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