Clinical trial NCT03362671: Implant Supported Oral Appliance Treatment of OSA
Official title: Bimaxillary Implant Supported Mandibular Advancement Pilot
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Obstructive Sleep Apnea
Keywords: OSA
Mandibular Advancement Splint
Oral Appliance
Treatment
Orthodontic Implants
Lead sponsor: University of British Columbia
Sponsor class: OTHER
First posted: 2017-12-05
Enrollment: 3
Sex: ALL
Minimum age (years): 25
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief 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.

Detailed 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.

Eligibility criteria: Inclusion Criteria:

This trial will recruit 10 patients with an objective diagnosis of obstructive sleep apnea who are not naïve to treatment. The inclusion criteria are:

* Currently receive or have previously received successful OSA treatment with an OAm;
* Age 25 - 65 years old, who are able to freely provide informed consent;
* Body Mass Index (BMI) ≤ 35;
* Apnea-Hypopnea Index (AHI) within the range 5≤AHI≤50 documented with polysomnography in the last 2 years \*\*\*OR\*\*\*
* Respiratory Disturbance Index (RDI) within the range 20 ≤ RDI ≤ 50 documented with Level III portable sleep test \*\*\*OR\*\*\*
* Oxygen Desaturation Index (ODI) ≥ 10

Exclusion Criteria:

The patient is excluded if it meets any of the following criteria:

* Extensive periodontal disease;
* Bleeding disorder;
* Bone metabolic disorder
* Immunocompromised
* Diabetes mellitus
* Xerostomia
* Titanium allergy
* Insufficient vertical opening to accommodate treatment with OAm;
* Pregnancy (if a participant becomes pregnant during the trial, the participant will be withdrawn from the study).
* Uncontrolled congestive heart failure (defined as a prior clinical diagnosis, an ejection cut-off of 40% or clinical sign in the opinion of a primary care physician or cardiologist) that makes it unsafe in the opinion of the investigators for the subject to participate in the trial;
* Coronary artery disease unless stable for at least 6 months and considered by the investigators to have a stable disease;
* Any history of angina, myocardial infarction or stroke;
* Any history of major depressive disorder along with current moderate-severe disease;
* Active cancer management (unless in remission for more than 1 year);
* Known renal failure (with need for dialysis)

Primary outcomes:
measure: Change in Apnea-Hypopnea Index (AHI)
timeFrame: Data collected at 0, and 1 months after initiation of treatment with the new appliance.
Secondary outcomes:
measure: Daytime Sleepiness
timeFrame: Data collected at 0, 1, and 4 months after initiation of treatment with the new appliance.
measure: Arterial Oxygen Saturation
timeFrame: Data collected at 0, 1, and 4 months after initiation of treatment with the new appliance.
measure: Treatment Adherence
timeFrame: Data will be collected by the research team 4 months after initiation of treatment with the new appliance.
measure: Patient Experience
timeFrame: Data collected 1 and 4 months after initiation of treatment with the new appliance.
measure: Mini Implant Side Effects - Mobility
timeFrame: Data collected at 1 week, 1 month and 4 months after initiation of treatment with the new appliance.
measure: Mini Implant Side Effects - Gingival Irritation
timeFrame: Data collected at 1 week, 1 month and 4 months after initiation of treatment with the new appliance.
measure: Mini Implant Side Effects - Soreness
timeFrame: Data collected at 1 week, 1 month and 4 months after initiation of treatment with the new appliance.
measure: Mini Implant Side Effects - Jaw Pain
timeFrame: Data collected at 1 week, 1 month and 4 months after initiation of treatment with the new appliance.
measure: Mini Implant Side Effects - Excess Salivation
timeFrame: Data collected at 1 week, 1 month and 4 months after initiation of treatment with the new appliance.
measure: Mini Implant Side Effects - Other
timeFrame: Data collected at 1 week, 1 month and 4 months after initiation of treatment with the new appliance.
Other outcomes:
Locations:
city: Vancouver
country: Canada
facility: University of British Columbia
state: British Columbia
Study officials:
affiliation: University British Columbia
name: Benjamin T Pliska, DDS
role: PRINCIPAL_INVESTIGATOR
References: