Therapy of Oral Appliance for Adults Jordanians With Obstructive Sleep Apnea

Study Overview
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Brief Summary
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Introduction: Obstructive Sleep Apnea (OSA) is the most common form of sleep disordered breathing. Patients who arrive at the dental office with a diagnosis of OSA are often treated with a mandibular advancement device (MAD). A biomimetic oral appliance therapy (BOAT), offers an alternative non-surgical method, which can putatively resolve OSA by combined maxilla-mandibular correction, and addressing craniofacial deficiencies. The aim: To determine whether maxilla-mandibular correction changes induced by BOAT produce a more favorable upper airway, which might result in a reduction in the severity of OSA. Protocol: Adults who underwent an overnight sleep study and were diagnosed by a sleep specialist physician will be potential subjects for the current study. The BQ and EES will be recorded pre- and post- BOAT treatment. Subjects with mild to moderate OSA will have 2 months follow up visits and a final overnight sleep study to measure apnea-hypopnea index (AHI). The subjects will be asked to wear the appliance for 10-12 hours/day and at night. Findings will be analyzed statistically using paired t-tests.

Official Title
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Biometric Oral Appliance Therapy for the Treatment of Obstructive Sleep Apnea in Adults

Conditions
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Mild Obstructive Sleep Apnea

Intervention / Treatment
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* Device: biomimetic oral appliance therapy (BOAT)
* Device: Standard hospital treatment


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Confirmed diagnosis of mild to moderate OSA with good oral hygiene Intolerant to CPAP therapy Having enough number of maxillary and mandibular teeth to retain the removable device. Exclusion Criteria: Patients who are unable to attend regular appointments and unable to consent. Patients with severe OSA who met the inclusion criteria

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 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: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Standard treatment<br> | Device: Standard hospital treatment<br>* Use of CPAP and similar methods<br>|
| Experimental: Oral Appliance<br> | Device: biomimetic oral appliance therapy (BOAT)<br>* BOAT appliance is designed to correct maxillo-mandibular underdevelopment in both children and adults (Singh and Lipka, 2009). However, adults will only use for this study. Typically, a BOAT appliance consists of 6 patented, anterior 3-D Axial Springs™, a midline actuator (such as omega loops or screws), posterior occlusal rests, and a round labial bow (Figure 1). Patients will be trained on activation of the screw<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| AHI |  | 12 weeks |