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

Not Applicable

Completed

Conditions: Obstructive Sleep Apnea

Interventions: Device: oral appliance - A ; washout; oral appliance B
Device: oral appliance - B; washout; oral appliance A

Registration Number: NCT03219034

Lead Sponsor: Texas A&M University

Brief Summary: 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: 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.

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 62

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

Study & Design

Study Type: INTERVENTIONAL

Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Oral appliance - B	oral appliance - B; washout; oral appliance A	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
Oral appliance - A	oral appliance - A ; washout; oral appliance B	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
Oral appliance - A	oral appliance - B; washout; oral appliance A	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
Oral appliance - B	oral appliance - A ; washout; oral appliance B	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

Primary Outcome Measures

Name	Time	Method
Respiratory Event Index (REI) at T2	4 weeks	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.

Secondary Outcome Measures

Name	Time	Method
Stable Sleep Percent	4 weeks	Percent of stable sleep during the recording, specifically the percentage of high frequency coupling (HFC%) from cardiopulmonary coupling (CPC) Analysis