Implant Supported Oral Appliance Treatment of OSA — BIMA  

Obstructive Sleep Apnea Clinical Trial

Official title: Bimaxillary Implant Supported Mandibular Advancement Pilot

Status Terminated

Clinical Trial Summary

Mandibular advancing oral appliances (OAm) are an effective and increasingly common treatment modality for the management of obstructive sleep apnea (OSA) in adults.

The effectiveness of OAm therapy, however, is dependent on a high level of patient adherence, which may be negatively impacted by treatment side effects - the most significant of which are occlusal changes and tooth movement.

The proposed pilot study will evaluate the efficacy of a novel implant supported OAm in 10 OSA patients who have already been successfully treated with a traditional OAm.

The study will compare OSA specific outcomes with traditional OAm use against novel oral appliance use after one month. This study could potentially validate the novel design features of an effective treatment option for OSA that does not result in tooth movement, which is a significant side effect shared by all existing OAm devices.

Ultimately, this study could lead to increased treatment adherence and better OSA patient health outcomes in the future.

Clinical Trial Description

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. ;

Related Conditions & MeSH terms

• Obstructive Sleep Apnea
• Sleep Apnea, Obstructive

• NCT number: NCT03362671
• Study type: Interventional
• Source: University of British Columbia
• Status: Terminated
• Phase: N/A
• Start date: April 1, 2018
• Completion date: September 11, 2019