Implant Supported Oral Appliance Treatment of OSA

Mandibular advancement oral appliances (OAm) are devices that keep the airway open during sleep by pulling the lower jaw forward. OAm have been shown to be an effective treatment for both mild and severe OSA. OSA is a chronic disease and there is no cure. OSA treatments depend on high patient adherence for long term effectiveness. Currently marketed OAm devices attach to the teeth as a way of holding the jaw in position. However, attaching directly to the teeth causes unwanted tooth movement with long term OAm use. As a result, some long-term users of OAm have stopped treatment due to a decrease in quality of life caused by tooth movement. Accordingly, the changes in tooth position can be seen as a limitation of the existing appliances. For this reason, there is a strong need for a type of treatment that can effectively pull the jaw forward without causing movement of the teeth, which is inevitable with the way the current OAm devices work. This trial is a pilot study to find out if a novel OAm device is an effective treatment for OSA. The novel OAm device does not contact the teeth directly but instead attaches to orthodontic mini implants (OMIs) in the jaw. 10 OSA patients who have previously been successfully treated with a traditional OAm appliance will be fitted with the novel oral appliance. Participants will be fitted with 6 OMIs following standard practice and the bespoke oral appliance will be manufactured and delivered to the patient for use. Prior to receiving treatment, participants will undergo a baseline assessment where demographic, anthropometric, and specific periodontal health data will be collected. Daytime sleepiness will be assessed and at-home sleep test will be used to establish baseline sleep parameters with the existing appliance. Follow up sleep tests will be completed 1 month after initiation of treatment with the new appliance. ESS questionnaires and treatment experience interviews will be completed at 1 month and 4 months after the start of treatment with the new appliance. Treatment adherence and OMI side effects will be monitored throughout the study. Patients will be given the option of continuing treatment with the novel device or having the implants removed and returning to treatment with their previous OAm. To directly address the primary aim of this study, OSA related parameters will be measured by a combination of methods including at-home sleep tests and Epworth Sleepiness Scale (ESS) questionnaires. Secondary outcome variables to assess treatment adherence and satisfaction include self-reported adherence data using sleep diaries, experience interviews and assessing OMI side effects throughout the study.