None listed
Conditions
Brief summary
Obstructive Sleep Apnoea is a common sleep-related breathing disorder and can be treated using a Mandibular Advancement Splint (MAS), an oral device worn during sleep which protrudes the mandible, improving airway calibre. Approximately two thirds of patients adequately resolve their sleep apnoea with this conventional therapy however; clinical trials have shown that the addition of a tongue restraining device significantly increases MAS effectiveness. This study will investigate the Tongue Tamer (TT) system, designed to be reversibly added to the conventional SomnoMed MAS to passively restrain the tongue. Safety, efficacy, tolerability and compliance of the TT MAS will be investigated in patients not demonstrating a complete response to conventional MAS treatment.
Interventions
This study will investigate the addition of the Tongue Tamer system to existing SomnoMed (Registered Trademark) Mandibular Advancement Splints (MAS) in patients not demonstrating a complete response with conventional MAS treatment. The Tongue Tamer is designed to hold the tongue in a more forward position, enhancing the ability of the appliance to keep the airways clear. Tongue Tamers will be inserted into existing devices by SomnoMed technicians and the participant will wear the device nightly
This study will investigate the addition of the Tongue Tamer system to existing SomnoMed (Registered Trademark) Mandibular Advancement Splints (MAS) in patients not demonstrating a complete response with conventional MAS treatment. The Tongue Tamer is designed to hold the tongue in a more forward position, enhancing the ability of the appliance to keep the airways clear. Tongue Tamers will be inserted into existing devices by SomnoMed technicians and the participant will wear the device nightly for 4 weeks. During this time, daily compliance diaries will be kept to monitor adherence and a final sleep study with the modified device will be performed after 4 weeks. These sleep study results will be compared to each individual's sleep study with the conventional MAS prior to alteration.
Sponsors
Prof. Peter Cistulli
Study design
Allocation
Non-randomised trial
Intervention model
Single group
Primary purpose
Treatment
Masking
Open (masking not used)
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
No
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
Outcome results
None listed