OrthoApnea NOA custom mouthpiece for obstructive sleep apnea

Effectiveness of NOA OATMAD

This project will see if the custom OrthoApnea NOA mouthpiece, used with a short-use Morning Aligner, can cut nighttime breathing pauses (AHI) by about half in adults with obstructive sleep apnea compared with other plastic mandibular devices.

Quick facts

• Study type: Observational
• Enrollment: 150 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: University of Alberta (Academic / other)
• Locations: 1 site (Edmonton, Alberta)
• Trial ID: NCT07111962 on ClinicalTrials.gov

What this trial studies

This observational cohort follows people using the OrthoApnea NOA appliance over three years and compares their outcomes to archived data from patients who used other nylon-based mandibular advancement devices. The main goal is a reduction in the Apnea-Hypopnea Index (AHI) of at least 50% and, where possible, an AHI below 5 events per hour. The study also tracks device durability, long-term adherence, patient comfort, and whether brief morning use of a Morning Aligner helps reposition the jaw and reduce side effects. All enrollment and follow-up occur at the University of Alberta, with clinical measures taken at baseline and scheduled intervals through the follow-up period.

Who should consider this trial

Good fit: Ideal candidates are adults with a confirmed diagnosis of obstructive sleep apnea who are using or willing to use the OrthoApnea NOA mandibular advancement appliance and can attend follow-up at the study site.

Not a fit: Patients without an OSA diagnosis, those with predominant central sleep apnea, severe uncontrolled medical conditions, or inadequate dentition to retain an oral appliance are unlikely to benefit from this approach.

Why it matters

Potential benefit: If successful, the NOA plus Morning Aligner could offer a more comfortable, durable oral alternative to CPAP that lowers AHI and improves long-term adherence and symptoms.

How similar studies have performed: Mandibular advancement devices have demonstrated success in lowering AHI for many patients with mild-to-moderate OSA, but the specific NOA device and the Morning Aligner combination have limited published data and are relatively novel.

Eligibility criteria

Inclusion Criteria:

* Dxed OSA being treated with NOA appliance

Exclusion Criteria:

* no OSA Dx

Where this trial is running

Edmonton, Alberta

• University of Alberta — Edmonton, Alberta, Canada (Recruiting)

Study contacts

• Study coordinator: Primary Investigator

Conditions Obstructive Sleep Apnea; obstructive sleep apnea; oral appliance therapy; mandibular advancement device