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
- Conditions
- Obstructive Sleep ApnoeaRespiratory - Sleep apnoea
- Registration Number
- ACTRN12615000037505
- Lead Sponsor
- Prof. Peter Cistulli
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot yet recruiting
- Sex
- All
- Target Recruitment
- 15
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
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
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method To determine the efficacy of the Tongue Tamer modification to reduce the overall Apnoea Hypopnea Index (AHI) when compared to the conventional MAS, as determined by a sleep study performed before (up to one year pre-modification) and after the modification. [After 4 weeks of using the Tongue Tamer modification];To determine the safety of the Tongue Tamer modification, this will be monitored through the daily compliance diary.[After 4 weeks of using the Tongue Tamer modification]
- Secondary Outcome Measures
Name Time Method To determine the compliance of patients- number of patients that use the device for greater than 4 hours as recorded by their compliance diary.[After 4 weeks of using the Tongue Tamer modification];To determine the tolerability of the device- the number of patients who use the device overall, regardless of time used, as recorded by their daily compliance diary. [After 4 weeks of using the Tongue Tamer modification]