Effectiveness of NOA OATMAD

Sponsor
University of Alberta
Study ID
NCT07111962
Status
Recruiting
Apply to this trial

Conditions

  • Obstructive Sleep Apnea

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Study Details

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.

Key Dates

First listed
Aug 8, 2025
Start date
Sep 30, 2025
Status verified
Feb 2026
Primary completion
Dec 31, 2030
Completion
Dec 31, 2030

Study Design

Enrollment
150 participants (estimated)

Primary Outcome Measure

AHI [ Time Frame: 3 years ]

Central Contacts

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