Effectiveness of NOA OATMAD

NCT07111962 | Recruiting

• 1 other identifier: Pro00154170
• Study Type: observational
• Target: 150
• Locations: 1 country
• Sites: 1

Brief Summary

This study is looking at how well the OrthoApnea NOA appliance, a special custom-made mouthpiece, helps treat people with obstructive sleep apnea (OSA). OSA is a common sleep problem where a person's breathing starts and stops many times during the night. Some people find it hard to use the usual treatment, called a continuous positive airway pressure (CPAP) machine, so this mouthpiece might be an easier and more comfortable option. The study is also checking if a small tool called the Morning Aligner, worn briefly in the morning, can help move the jaw back to its normal position. This might help people feel better and reduce side effects. The study will last for three years. During this time, researchers will watch how people do while using the OrthoApnea NOA and compare their results to those of other people who used different types of plastic mouthpieces. The main goal is to see if the NOA can cut the number of times a person stops breathing during sleep by at least half. They hope to reduce it to fewer than 5 times an hour, which is close to normal. They will also check other things like how much oxygen people get while sleeping, their weight, how sleepy they feel during the day, how comfortable the mouthpiece is, how long it lasts, and how often people keep using it. Instead of picking who gets which mouthpiece at random, this study uses a different method. It compares new patients using the NOA to past patients who used other mouthpieces. This is more like what happens in real life at clinics. By studying both new and past data, the researchers hope to better understand how the NOA works over time and how it compares to other options. This information will help dentists, sleep doctors, and patients choose the best way to treat sleep apnea using mouthpieces.

Conditions

Obstructive Sleep Apnea

Keywords

obstructive sleep apnea; oral appliance therapy; mandibular advancement device

Outcome Measures

Primary Outcomes (1)

• AHI

  Disease Index

  3 years

Secondary Outcomes (1)

• Side Effects

  3 years

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

adults with OSA

You may qualify if:

• Dxed OSA being treated with NOA appliance

You may not qualify if:

• no OSA Dx

Sponsors & Collaborators

• University of Alberta: lead
• Orthoapnea: collaborator

Study Sites (1)

University of Alberta

Edmonton, Alberta, T6G2R3, Canada

RECRUITING

MeSH Terms

Conditions

Sleep Apnea, Obstructive

Condition Hierarchy (Ancestors)

Sleep Apnea Syndromes; Apnea; Respiration Disorders; Respiratory Tract Diseases; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Nervous System Diseases

Central Study Contacts

Primary Investigator

CONTACT

(780) 492-7696; airwayresearchdsm@gmail.com

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 7, 2025
• First Posted: August 8, 2025
• Study Start: September 30, 2025
• Primary Completion (Estimated): December 31, 2030
• Study Completion (Estimated): December 31, 2030
• Last Updated: February 10, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)