Workflow Validation of an In-home Auto-titrating Mandibular Positioner

Study Overview
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Brief Summary
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The purpose of the study is to test the workflow of an auto-titrating mandibular positioner in its intended setting. Participants with obstructive sleep apnea will use the device to determine their eligibility for oral appliance therapy and provide feedback on usability of the device.

Detailed Description
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One treatment for obstructive sleep apnea is oral appliance therapy during sleep, in which an appliance that covers the upper and lower teeth acts to pull the lower jaw forward, opening the throat passage and allowing for normal breathing. However, oral appliance therapy does not treat sleep apnea effectively in all individuals. In order to identify those individuals for whom oral appliance therapy will work, the study sponsor has developed an investigational device called an auto-titrating mandibular positioner. The device automatically pulls the lower jaw forward in response to respiratory events while the individual sleeps. Study participants will learn the outcome of their sleep tests and will provide feedback on the ease of use of the device.

Official Title
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Workflow Validation of an In-home Auto-titrating Mandibular Positioner

Conditions
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Obstructive Sleep Apnea

Intervention / Treatment
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* Device: Auto-titrating mandibular positioner test


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Minimum 18 years of age Participant has been deemed suitable for oral appliance therapy Prescription for oral appliance Adequate range of motion Adequate dentition Ability to understand and provide informed consent Ability and willingness to meet the required schedule Exclusion Criteria: Loose teeth or advanced periodontal disease Full dentures or dental implants

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: AMP test group<br>All individuals will undergo a test using the auto-titrating mandibular positioner. | Device: Auto-titrating mandibular positioner test<br>* Participants will undergo a theragnostic test using the auto-titrating mandibular positioner to determine if they are eligible candidates to use oral appliance therapy for their obstructive sleep apnea. The device works by moving the lower jaw forward in response to respiratory events while the participant sleeps. All participants will undergo the same test.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Integration of the device into the existing workflow of a dental sleep medicine practice | Data for this outcome are largely directed at the study staff, not study participants. Data collected for this outcome include: time required to evaluate eligibility for device use, prepare device for use, and ease of scheduling of study visits | 1 year | 
| Convenience and feasibility of carrying out a multi-night AMP study in the home | Participants will complete a questionnaire following their AMP tests to collect data on ease of use of the device and opinion of the various device components. | 1 year | 
| Feasibility of instructing the participant on the use of the AMP device at the practitioner's office | Data for this outcome are directed at study staff, not study participants. Data collected will include feedback on ease of training participants on device use. Participants will be asked if they felt they received adequate training from the study staff via a questionnaire. | 1 year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Time to treatment | Time to treatment will be evaluated by tracking the time from the first consultation at the dentist's office to the setting of the temporary appliance (for individuals whose tests indicate they are predicted candidates for oral appliance therapy). | 1 year | 
| Number of study visits | The number of study visits will be recorded. This data will be collected from study records and does not require input from the participant. | 1 year | 
| Length of study visits | The length of each visit (minutes) will be recorded. This data will be collected from study records and does not require input from the participant. | 1 year | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Oral appliance therapy