Effectiveness of NOA OATMAD

Research Proposal: Evaluating the Effectiveness of the OrthoApnea NOA Dental Appliance in Treating Obstructive Sleep Apnea (OSA)

• Purpose of the Study This study will evaluate how effective the OrthoApnea NOA dental appliance is at treating patients with mild, moderate, and severe obstructive sleep apnea (OSA). It will also assess the Morning Aligner as a supporting tool to maintain jaw alignment and comfort.

In addition to following patients prospectively over three years, this study will also analyze and compare pre-existing clinical data from other patients who have used different nylon-based mandibular advancement devices. This approach will allow us to assess relative performance in terms of treatment outcomes, comfort, and long-term adherence.

• Hypothesis The OrthoApnea NOA, used with the Morning Aligner, will reduce the Apnea-Hypopnea Index (AHI) by at least 50%, with a goal of bringing AHI to fewer than 5 events per hour in many patients.

Compared to other nylon-based dental appliances, the NOA will show:

Better long-term efficacy

Longer retention time (device durability)

Higher adherence to treatment

Improved patient comfort and satisfaction

• Justification Dental sleep appliances are a valuable alternative for patients who cannot tolerate continuous positive airway pressure (CPAP) therapy. The OrthoApnea NOA is a custom-made, modern appliance designed for maximum comfort, adjustability, and effectiveness. Including the Morning Aligner in the treatment may enhance comfort and prevent bite changes.

There is currently limited long-term real-world data comparing this device with other nylon-based appliances. This study aims to fill that gap by evaluating both new patients and historical patient data, providing robust evidence to support treatment decisions.

• Objectives Primary Objective To evaluate whether the OrthoApnea NOA reduces AHI by ≥50%, with a goal of achieving <5 events per hour.

Secondary Objectives

Measure improvements in:

AHI (Apnea-Hypopnea Index)

CT90 (percentage of time with oxygen saturation below 90%)

BMI (body mass index)

Epworth Sleepiness Scale (ESS) scores

Device retention/durability

Jaw alignment and dental comfort

Patient adherence and satisfaction

• Study Design and Methods Design Quasi-experimental, comparative longitudinal study

Two groups:

Prospective cohort using the OrthoApnea NOA + Morning Aligner

Retrospective cohort of patients treated with other nylon-based oral appliances (existing clinic data)

Sample

Total Sample Size: 250

Intervention Sample Size: 100 patients in the prospective NOA group

Historical Comparison Group: 100-150 matched patients from prior records

Sample Size and Power Calculation

Calculated using the Harvard Hedwig sample size calculator sing a 2 sided alpha of 0.05, power of 0.9 with a standard deviation of 10 and a difference in means of 5 and a dropout rate of approximately 20% for the prospective group

• Data Collection and Follow-up

Prospective Group (OrthoApnea NOA + Morning Aligner):

Sleep studies at baseline, 6, 12, 18, 24, and 36 months

CT90, BMI, ESS, and dental/jaw evaluations

Patient questionnaires on comfort, satisfaction, and adherence

Device assessments for wear and retention

Retrospective Group (Other nylon appliances):

Extract AHI, CT90, BMI, ESS, and device durability from patient records

Match based on age, gender, OSA severity, and BMI

• Data Analysis Plan Primary Analysis

Compare changes in AHI from baseline to follow-up between the NOA group and retrospective nylon appliance group using:

Independent t-tests or ANCOVA for continuous variables (adjusting for baseline values)

Chi-square tests for categorical outcomes (e.g., proportion of patients achieving AHI < 5)

Secondary Analyses Longitudinal trends in AHI, CT90, ESS, and BMI using mixed-effects models

Analysis of device durability and patient adherence using survival analysis or time-to-event methods

Evaluate correlations between adherence, comfort, and clinical improvement

Subgroup analysis by OSA severity (mild, moderate, severe)

Data Matching and Control

Retrospective data will be matched to prospective participants based on:

Age Sex Baseline AHI category BMI Propensity score matching may be used for more accurate comparisons

This study combines real-world clinical data with a prospective follow-up to evaluate the long-term effectiveness of the OrthoApnea NOA appliance and its companion Morning Aligner. It will provide strong, comparative evidence of its performance against other nylon-based devices in terms of sleep improvement, patient comfort, and adherence-information that is critically needed for guiding future treatment recommendations in dental sleep medicine.

Inclusion criteria

• Dxed OSA being treated with NOA appliance

Exclusion criteria

• no OSA Dx