OrthoApnea NOA custom mouthpiece for obstructive sleep apnea
Official title: Effectiveness of NOA OATMAD
Run by University of Alberta · NCT07111962 · Data updated 2026-11-12
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 |
|---|---|
| Ages | 18 Years and up |
| Sex | All |
| Enrollment | 150 (estimated) |
| Sponsor | University of Alberta Academic / other |
| Locations | 1 site (Edmonton, Alberta) |
| Status | Recruiting |
| Started | September 30, 2025 |
| Main results expected | December 31, 2030 |
| Study ends | December 31, 2030 |
| Registry record updated | February 10, 2026 |
| Trial ID | NCT07111962 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a 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.
✕Probably 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.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
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.
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 gone: 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.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion Criteria: * Dxed OSA being treated with NOA appliance Exclusion Criteria: * no OSA Dx
Where it's running
-
University of Alberta
Edmonton, Alberta, Canada Recruiting
Study contacts
- Study coordinator: Primary Investigator
- Email: airwayresearchdsm@gmail.com
- Phone: (780) 492-7696
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.