Efficacy of the OrthoApnea NOA® Mandibular Advancement Device in the Management of Obstructive Sleep Apnea. Clinical Trial and Retrospective Comparison Study.
Phase: NA
Conditions: Obstructive Sleep Apnea
Sponsor: Isabel Moreno Hay

Document Coversheet
Study Title: Efficacy of the OrthoApnea NOA® Mandibular Advancement Device in the 
Management of Obstructive Sleep Apnea. Clinical Trial and Retrospective Comparison Study
Institution/Site: 
University of Kentucky
Document (Approval/Update) Date:
2/3/2023 
NCT Number:
NCT05139303
IRB Number 
71295
Coversheet created:
8/1/2024 

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STATISTICAL METHODS: For the prospective section, a power analysis was conducted based on 
effect sizes or efficacy of other MAD appliances as previously reported in the literature. Based on the 
effect sizes of the MAD based on the meta-analyses (d
-2.063),(9) we conducted a meta-analysis using 
GPower which revealed that obtaining a sample size of 33 participants would provide us 80% power to 
detect the anticipated effects.  
Aim 1.1 was to assess the efficacy of the NOA® mandibular advancement device. To do this, we had two 
different criteria for success as defined before. For each of these criteria, we calculated the proportion of 
patients who “succeeded” vs. “failed.” As exploratory analyses, we used independent samples t-test or 
chi-square testes (as appropriate) to compare baseline demographic characteristics between those who 
succeeded and failed for each of the criteria. Aim 1.2 was to describe the percentage of advancement (%) 
needed to reach efficacy for the NOA® appliance in the management of obstructive sleep apnea. For this 
aim, we only examined the data of those who “succeeded” in Aim 1.1. Paired samples t-tests were carried 
out to detect the possible statistically significant differences in each of the parameters studied before and 
after receiving the treatment. The sociodemographic characteristics and other variables of interest of the 
patients included in the prospective and retrospective studies were described (n, mean ± SD).   
Aim 2 was to describe patient compliance to the NOA® device in the management of obstructive sleep 
apnea. Using the definition of compliance provided above, we computed the proportion of study 
participants who complied with the NOA® appliance and described the use in terms of nights per week 
and hours per night (n, mean ± SD).  
Aim 3 was to assess the incidence and prevalence of temporomandibular disorder (TMD) diagnoses, 
morning headaches, possible sleep bruxism, nighttime voids, sleep quality, side effects, and of problems 
related to the NOA® appliance during the titration process by using paired samples t-test or chi-square 
testes (as appropriate) to compare baseline and final values between those who succeeded and failed for 
each of the criteria. 
Mean and standard deviation and other centralization measures were calculated for quantitative variables, 
frequencies, and percentage values were calculated for categorical variables. The McNemar test was used 
as a significance test, with which assessed if there were significant changes. Statistical significance was 
defined by p <0.05. All analyses were conducted using SPSS version 29.