Trial on Oral Appliance Design for Improving Upper Airway Function and Sleep Quality
| Status: | Recruiting |
|---|---|
| Conditions: | Insomnia Sleep Studies, Pulmonary |
| Therapuetic Areas: | Psychiatry / Psychology, Pulmonary / Respiratory Diseases |
| Healthy: | No |
| Age Range: | 18 - Any |
| Updated: | 10/14/2017 |
| Start Date: | October 10, 2017 |
| End Date: | October 30, 2018 |
| Contact: | Emet Schneiderman, PhD |
| Email: | emet@tamhsc.edu |
| Phone: | 12148288377 |
Mid-line Traction Versus Bilateral Thrust Oral Appliances: A Trial to Determine Superiority for Improving Upper Airway Function and Sleep Quality
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.
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.
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.
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.
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
We found this trial at
1
site
3302 Gaston Avenue
Dallas, Texas 75246
Dallas, Texas 75246
Phone: 214-828-8377
Click here to add this to my saved trials
