Clinical trial Recruiting at 1 site Observational Ages 18 and up

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 typeObservational
Ages18 Years and up
SexAll
Enrollment150 (estimated)
SponsorUniversity of Alberta
Academic / other
Locations1 site (Edmonton, Alberta)
StatusRecruiting
StartedSeptember 30, 2025
Main results expectedDecember 31, 2030
Study endsDecember 31, 2030
Registry record updatedFebruary 10, 2026
Trial IDNCT07111962 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

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

How to take part

  1. Review the eligibility criteria above with your treating physician.
  2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
  3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.
Last reviewed 2026-11-14 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.