Changes in Upper Airway Anatomy, Quality of Life Measures, and Polysomnographic Parameters Using A Functional Dental Appliance

Study Overview
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Brief Summary
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A prospective study measuring changes in upper airway anatomy, quality of life measures, and polysomnographic parameters using a functional dental appliance (Homeoblock)

Detailed Description
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Although rising levels of obesity heavily influences the increasing rates of obstructive sleep apnea (OSA), detailed analysis of more basic etiology suggests a possible craniofacial origin. Specifically, modern humans' facial structures a slowly shrinking, which can narrow the upper airway. This is evidenced by the fact that rates of malocclusion and impacted (or non-existent) wisdom teeth are increasing in modern, Westernized countries. Obstructive sleep apnea is a commonly seen condition characterized by multiple episodes of obstructed breathing during sleep, with intermittent hypoxia. Untreated OSA is associated with significantly higher rates of high blood pressure, diabetes, heart disease, heart attack, stroke, sudden death, and car accidents. The gold standard treatment for OSA is continuous positive airway pressure (CPAP), but compliance is poor. Initially, out of 100 patients, 20 will refuse CPAP. After one year 50% of the 80 remaining patients will be using CPAP, but only 50% will be using it effectively, leaving only 20 patients who are using CPAP effectively. (personal communication, Stepnowski). An alternative option in people with mild to moderate OSA is a mandibular advancement device, which functions by pulling the genioglossus muscle forward. Long-term use of CPAP and mandibular advancement devices have been shown to aggravate malocclusion. Numerous surgical options are available for select patients, but only as a last resort. In children, one uncommonly used, but effective form of treating OSA is by application of a palatal expander by an orthodontist. In theory, this option is effective due to the fact the palatal suture line is not completely fused in children. The general consensus in dentistry is that adults have fused midline palatal suture line and the hard palate cannot be expanded. Recent work by numerous investigators suggests that palatal expansion can occur to significant degrees, even in adults. Case reports have been published with the AHI diminishing significantly after therapy. Not only can the hard palate widen, there can also be significant growth of new maxillary bone growth and anterior mandibular bone growth. Jaw development is linked to airway development. The Homeoblock is once such appliance that is based on principles of epigenetics. Mechanical stimulation by the device is thought to initiate gene transcription within the periodontal ligament, creating dental movement and new bone formation. Our study aims to determine the efficacy of the Homeoblock in patients with obstructive sleep apnea with regards to changes in polysomnographic parameters, functional quality of life measures, and upper airway anatomy size using low-dose CT imaging.

Official Title
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Changes in Upper Airway Anatomy, Quality of Life Measures, and Polysomnographic Parameters Using A Functional Dental Appliance

Conditions
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Obstructive Sleep Apnea, Malocclusion

Intervention / Treatment
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* Device: Homeoblock


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Documented AHI > 15 on polysomnography Refuses CPAP Able to fill our QOL and sleep questionnaires (pre and one year post treatment) Willing to undergo CBCT radiologic testing x 2 (pre and 1 year post treatment) Exclusion Criteria: neurologic conditions dementia central sleep apnea heart failure, seizures age < 18 severe nasal congestion insufficient teeth lack of manual dexterity

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Homeoblock functional dental appliance<br>Removable functional dental appliance to be used at during sleep for one year. | Device: Homeoblock<br>* A removable, functional dental appliance to be worn nightly for 1 year Pending 510(k) clearance for the use of reducing snoring and mild to moderate obstructive sleep apnea in adults. A class II medical device.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Polysomnographic (PSG) parameters, mainly AHI and O2 desaturation measures | Comparison of PSG data between pre-therapy and post-therapy values at one year | Through study completion. Data to be re-collected after one year of therapy for each participant | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Epworth Sleepiness Scale | Commonly used validated tool for sleep research | Comparison of data between pre-therapy and post-therapy values at one year for each participant | 
| Functional Outcome of Sleep Questionnaire (FOSQ) | Commonly used validated tool for sleep research | Comparison of data between pre-therapy and post-therapy values at one year for each participant | 
| Nasal obstruction symptom evaluation (NOSE) | Commonly used validated tool for otolaryngology research | Comparison of data between pre-therapy and post-therapy values at one year for each participant | 
| Upper airway volume changes based on low-dose CT imaging (CBCT) | Various upper ariway volume measurements as well as craniofacial landmarks Orthodontists routinely perform periodic CBCT imaging to assess progress. A one year interval is well within standards of care. | Comparison of CBCT data between pre-therapy and post-therapy values at one year | 
| BMI |  | Comparison of data between pre-therapy and post-therapy values at one year | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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obstructive sleep apnea, malocclusion, polysomnography, quality of life