Trial on Oral Appliance Design for Improving Upper Airway Function and Sleep Quality

Study Overview
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Brief Summary
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This study will compare the effectiveness of the two leading oral appliances (OAs) designs for the treatment of severe obstructive sleep apnea in overweight adults. The effectiveness of OAs has come under question since different designs are combined in evaluating treatment efficacy, for example when comparing them to continuous positive airway pressure Due to the wide range of reported efficacy (53 to 90%), it is of great value to identify the most effective design to guide sleep practitioners and patients.

Detailed Description
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The two prominent oral appliances used in treating obstructive sleep apnea differ in their designs, mid-line traction versus bilateral thrust. From a clinical perspective, it is important to know which design is superior and should be the 'treatment of choice' for improving airway function and sleep quality. These two designs differ in their protrusive mechanisms that are categorized in general under four main types: bilateral compression, bilateral thrust, midline compression and mid-line traction. Although the two designs considered in this proposal have undergone the most rigorous testing individually, well controlled 'head-to-head' trials as proposed here have not been conducted to determine their efficacy within a single test population.

Official Title
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Mid-line Traction Versus Bilateral Thrust Oral Appliances: A Trial to Determine Superiority for Improving Upper Airway Function and Sleep Quality

Conditions
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Obstructive Sleep Apnea

Intervention / Treatment
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* Device: oral appliance - A ; washout; oral appliance B
* Device: oral appliance - B; washout; oral appliance A


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: OSA PSG or PG diagnosed adults within 1 year age >18 Currently treated with continuous positive airway pressure (CPAP) AHI ≥ >30 events/hour of sleep Two or more OSA symptoms (snoring, witnessed apnea or daytime hypersomnolence complaint) BMI ≥ 30 At least 8 teeth per arch to support either OA device Central and mixed apnea index <5 events/hour Mallampati score from I to III Palatine tonsils - grade 0, 1, or 2 Consent to study's timeline Willingness to wear home sleep test apparatus for at least 4 nights Willingness to wear an oral appliance every night for 8 weeks Willingness to pick up and return home sleep test kits as needed Exclusion Criteria: Cardiac & pulmonary disease (e.g., congestive heart failure, severe arrhythmias, COPD); Central sleep apnea; Comorbidities with other sleep disorders No active TMD or jaw muscle pain Morphological airway abnormalities Pre-existing difficulty swallowing; throat or neck related health issues Endocrine dysfunction Severe psychiatric disorders; Previous OA therapy; ENT surgery Restrictions in jaw opening Pregnancy / breast feeding or intent to become pregnant during the study Inability to apply the sleep recorders

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: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Oral appliance - A<br>Anti-snoring intra-oral appliance that consists of two custom fitted trays which fit over the upper and lower teeth and uses a Midline Traction Mechanism to advance the mandible. The coupling mechanism is located at a single point midline, allows adjustment by incremental protraction (advancement) of the mandible. Trade Name: TAP1 Oral Appliance, Airway Management Inc. Dallas, TX | Device: oral appliance - A ; washout; oral appliance B<br>* Anti-snoring intra-oral appliance A that consists of two custom fitted trays which fit over the upper and lower teeth and uses a Midline Traction Mechanism to advance the mandible. The coupling mechanism is located at a single point midline, allows adjustment by incremental protraction (advancement) of the mandible. 1 week washout followed by anti-snoring intra-oral appliance B that consists of two custom fitted trays which fit over the upper and lower teeth uses a Bilateral Thrust Mechanism to advance the mandible. The trays are engaged by means of adjustable lugs.<br>* Other names: TAP1 Oral Appliance; washout; SomnoDent Flex;Device: oral appliance - B; washout; oral appliance A<br>* Anti-snoring intra-oral appliance B that consists of two custom fitted trays which fit over the upper and lower teeth uses a Bilateral Thrust Mechanism to advance the mandible. The trays are engaged by means of adjustable lugs. 1-week washout followed by anti-snoring intra-oral appliance A that consists of two custom fitted trays which fit over the upper and lower teeth and uses a Midline Traction Mechanism to advance the mandible. The coupling mechanism is located at a single point midline, allows adjustment by incremental protraction (advancement) of the mandible.<br>* Other names: SomnoDent Flex; washout; TAP1;|
| Experimental: Oral appliance - B<br>Anti-snoring intra-oral appliance that consists of two custom fitted trays which fit over the upper and lower teeth uses a Bilateral Thrust Mechanism to advance the mandible. The trays are engaged by means of adjustable lugs. Trade name: SomnoDent Flex Oral Appliance, SomnoMed Inc., Plano TX | Device: oral appliance - A ; washout; oral appliance B<br>* Anti-snoring intra-oral appliance A that consists of two custom fitted trays which fit over the upper and lower teeth and uses a Midline Traction Mechanism to advance the mandible. The coupling mechanism is located at a single point midline, allows adjustment by incremental protraction (advancement) of the mandible. 1 week washout followed by anti-snoring intra-oral appliance B that consists of two custom fitted trays which fit over the upper and lower teeth uses a Bilateral Thrust Mechanism to advance the mandible. The trays are engaged by means of adjustable lugs.<br>* Other names: TAP1 Oral Appliance; washout; SomnoDent Flex;Device: oral appliance - B; washout; oral appliance A<br>* Anti-snoring intra-oral appliance B that consists of two custom fitted trays which fit over the upper and lower teeth uses a Bilateral Thrust Mechanism to advance the mandible. The trays are engaged by means of adjustable lugs. 1-week washout followed by anti-snoring intra-oral appliance A that consists of two custom fitted trays which fit over the upper and lower teeth and uses a Midline Traction Mechanism to advance the mandible. The coupling mechanism is located at a single point midline, allows adjustment by incremental protraction (advancement) of the mandible.<br>* Other names: SomnoDent Flex; washout; TAP1;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Respiratory Event Index (REI) at T2 | Number of apneas and hypopneas (respiratory events) per hour of recording; REI was reported instead of AHI, as it is a more appropriate measure for home sleep testing. | 4 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Stable Sleep Percent | Percent of stable sleep during the recording, specifically the percentage of high frequency coupling (HFC%) from cardiopulmonary coupling (CPC) Analysis | 4 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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oral appliance, sleep quality, sleep apnea