Efficacy of the OrthoApnea NOA® Mandibular Advancement Device in the Management of Obstructive Sleep Apnea.

Study Overview
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Brief Summary
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The objective of this study is to assess the efficacy of the Orthoapnea NOA® mandibular advancement device and describe the percentage of advancement (%) needed to reach efficacy, and to retrospectively compare with other MAD designs in the management of obstructive sleep apnea. Additionally, to describe patient compliance and adherence to the therapy with the Orthoapnea NOA® device, and to assess the incidence and prevalence of signs, symptoms, and diagnosis of temporomandibular disorders (TMD) associated to the use of the Orthoapnea NOA® mandibular advancement device.

Official Title
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Efficacy of the OrthoApnea NOA® Mandibular Advancement Device in the Management of Obstructive Sleep Apnea. Clinical Trial and Retrospective Comparison Study.

Conditions
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Obstructive Sleep Apnea

Intervention / Treatment
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* Device: Orthoapnea NOA®


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age: >18 and <80 years old. No history of previous use of a MAD. Diagnosis of OSA by a sleep physician based on a PSG or HSAT (done >12 months before evaluation date or > 12 months with >10% variation of BMI). Upon clinical examination: >8 teeth per arch; range of anteroposterior mandibular mobility >5 mm. Informed consent to participate in the study. Exclusion Criteria: Patients with concomitant diagnosed sleep disorders (i.e. insomnia, narcolepsy, restless legs syndrome, rapid eye movement sleep behavior disorder). History of previous allergic reaction to the appliance material (Polyamide 12). Patients using combination therapy for the management of OSA (i.e. PAP therapy or positional therapy). Upon clinical examination: periodontal disease (>4 mm on periodontal probing, with bleeding on probing, visual signs of periodontal inflammation); tooth horizontal mobility >1 mm, vertical mobility, and unfavorable crown to root ratio; open cavities, loose or fractured restorations, or patient undergoing restorative dental treatments. Exaggerated gag reflex. Lack of coordination or dexterity. Inadequate English comprehension.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 79 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
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: MAD therapy<br> | Device: Orthoapnea NOA®<br>* The efficacy of the appliance for the management of OSA will be stablished based on two criteria. Criterion I: > 50% reduction of AHI/RDI. Criterion II: AHI/RDI < 5 events/hour or <15 events/hour with a significative reduction of OSA associates symptoms as defined before. Therapeutic failure will be established when at 100% of advancement of the device, there is less than 50% of reduction of the AHI/RDI with a residual AHI/RDI >5 events/hour with OSA associates symptoms.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To assess the efficacy of the Orthoapnea NOA® mandibular advancement device and describe the percentage of advancement (%) needed to reach efficacy. | Assessment of efficacy of the device: After delivery, the MAD will be advanced 10% every 2 weeks until maximum therapeutic benefit. Sleep parameters (AHI, RDI, min. and average oxygen saturation) will be extracted from the initial PSG, and from a final confirmatory home sleep apnea test. The efficacy will be stablished based on: Criterion I: > 50% reduction of AHI/RDI; Criterion II: AHI/RDI < 5 events/hour or <15 events/hour with a significant reduction of OSA associates symptoms. | 16 weeks. | 
| To retrospectively compare with other MAD designs. | Retrospective comparison with other MAD designs: Archival data will be extracted from records of patients that started MAD therapy for OSA at the same center between 01/01/2010-08/17/2021, and that had a second sleep study performed to assess the effectiveness of the MAD. Data regarding demographic characteristics (age (years), gender (male, female), BMI (kg/m²) and OSA diagnosis (mild, moderate, and severe)), sleep parameters (AHI (events/hour), RDI (events/hour), minimum and average oxygen saturation (%)), level of advancement of the MAD (%), and compliance (nights of use per week) of use will be extracted. | 16 weeks. | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Describe patient compliance and adherence to the therapy with the Orthoapnea NOA® device. | The self-reported use of MAD will be assessed at each follow-up via questionnaire on a five-point checklist (number hours per night and nights per week). Compliance will be defined as wearing the appliance for ≥4 hours per night during at least 70% of the nights. | 16 weeks. | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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OSA, Obstructive sleep apnea, mandibular advancement device, oral appliance