Obstructive Sleep ApneaNCT07111962
Effectiveness of NOA OATMAD
An observational study of Obstructive Sleep Apnea, run by University of Alberta at 1 site in Canada.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Obstructive Sleep Apnea
- How many people
- 150 participants
- Where
- 1 siteCanada
- Study dates
- 30 Sep 2025to 31 Dec 2030
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: adults with OSA
Who may be able to join
- Dxed OSA being treated with NOA appliance
Who cannot join
- no OSA Dx
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Canada1 site, 1 recruiting
- Recruiting
University of Alberta
Edmonton, Alberta, T6G2R3
Enoch Ng, (780) 492-7696, airwayresearchdsm@gmail.com
About this study
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.
Read the detailed description
Research Proposal: Evaluating the Effectiveness of the OrthoApnea NOA Dental Appliance in Treating Obstructive Sleep Apnea (OSA)
- Purpose of the Study This study will evaluate how effective the OrthoApnea NOA dental appliance is at treating patients with mild, moderate, and severe obstructive sleep apnea (OSA). It will also assess the Morning Aligner as a supporting tool to maintain jaw alignment and comfort. In addition to following patients prospectively over three years, this study will also analyze and compare pre-existing clinical data from other patients who have used different nylon-based mandibular advancement devices. This approach will allow us to assess relative performance in terms of treatment outcomes, comfort, and long-term adherence.
- Hypothesis The OrthoApnea NOA, used with the Morning Aligner, will reduce the Apnea-Hypopnea Index (AHI) by at least 50%, with a goal of bringing AHI to fewer than 5 events per hour in many patients. Compared to other nylon-based dental appliances, the NOA will show: Better long-term efficacy Longer retention time (device durability) Higher adherence to treatment Improved patient comfort and satisfaction
- Justification Dental sleep appliances are a valuable alternative for patients who cannot tolerate continuous positive airway pressure (CPAP) therapy. The OrthoApnea NOA is a custom-made, modern appliance designed for maximum comfort, adjustability, and effectiveness. Including the Morning Aligner in the treatment may enhance comfort and prevent bite changes. There is currently limited long-term real-world data comparing this device with other nylon-based appliances. This study aims to fill that gap by evaluating both new patients and historical patient data, providing robust evidence to support treatment decisions.
- Objectives Primary Objective To evaluate whether the OrthoApnea NOA reduces AHI by ≥50%, with a goal of achieving <5 events per hour. Secondary Objectives Measure improvements in: AHI (Apnea-Hypopnea Index) CT90 (percentage of time with oxygen saturation below 90%) BMI (body mass index) Epworth Sleepiness Scale (ESS) scores Device retention/durability Jaw alignment and dental comfort Patient adherence and satisfaction
- Study Design and Methods Design Quasi-experimental, comparative longitudinal study Two groups: Prospective cohort using the OrthoApnea NOA + Morning Aligner Retrospective cohort of patients treated with other nylon-based oral appliances (existing clinic data) Sample Total Sample Size: 250 Intervention Sample Size: 100 patients in the prospective NOA group Historical Comparison Group: 100-150 matched patients from prior records Sample Size and Power Calculation Calculated using the Harvard Hedwig sample size calculator sing a 2 sided alpha of 0.05, power of 0.9 with a standard deviation of 10 and a difference in means of 5 and a dropout rate of approximately 20% for the prospective group
- Data Collection and Follow-up Prospective Group (OrthoApnea NOA + Morning Aligner): Sleep studies at baseline, 6, 12, 18, 24, and 36 months CT90, BMI, ESS, and dental/jaw evaluations Patient questionnaires on comfort, satisfaction, and adherence Device assessments for wear and retention Retrospective Group (Other nylon appliances): Extract AHI, CT90, BMI, ESS, and device durability from patient records Match based on age, gender, OSA severity, and BMI
- Data Analysis Plan Primary Analysis
Compare changes in AHI from baseline to follow-up between the NOA group and retrospective nylon appliance group using:
Independent t-tests or ANCOVA for continuous variables (adjusting for baseline values)
Chi-square tests for categorical outcomes (e.g., proportion of patients achieving AHI < 5)
Secondary Analyses Longitudinal trends in AHI, CT90, ESS, and BMI using mixed-effects models
Analysis of device durability and patient adherence using survival analysis or time-to-event methods
Evaluate correlations between adherence, comfort, and clinical improvement
Subgroup analysis by OSA severity (mild, moderate, severe)
Data Matching and Control
Retrospective data will be matched to prospective participants based on:
Age Sex Baseline AHI category BMI Propensity score matching may be used for more accurate comparisons
This study combines real-world clinical data with a prospective follow-up to evaluate the long-term effectiveness of the OrthoApnea NOA appliance and its companion Morning Aligner. It will provide strong, comparative evidence of its performance against other nylon-based devices in terms of sleep improvement, patient comfort, and adherence-information that is critically needed for guiding future treatment recommendations in dental sleep medicine.
- Conditions
- Obstructive Sleep Apnea
- Keywords
- obstructive sleep apnea, oral appliance therapy, mandibular advancement device
- Medical subject headings
- Sleep Apnea, Obstructive
What is being measured
The primary outcome is the main question the study is designed to answer.
AHI
Disease Index
Measured: 3 years
Secondary outcomes (1)
Side Effects
Side Effects (changes to bite/occlusion, TMJ symptoms/myalgia)
Measured: 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Aug 2025
- Study start30 Sep 2025
- Primary completion31 Dec 2030 (estimated)
- Study completion31 Dec 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Obstructive Sleep ApneaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 150 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Alberta
- Sponsor type
- University, hospital or other
- Collaborators
- Orthoapnea
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07111962
- Sponsor's protocol ID
- Pro00154170
- Status last verified
- Feb 2026
- First submitted
- 7 Jul 2025
- Last updated
- 10 Feb 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness of NOA OATMAD
- ClinicalTrials.gov ID
- NCT07111962
- Acronym / sponsor ID
- Pro00154170
- Conditions
- Obstructive Sleep Apnea
- Keywords
- obstructive sleep apnea, oral appliance therapy, mandibular advancement device
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- University of AlbertaUniversity, hospital or other
- Collaborators
- Orthoapnea
- Study start
- 30 Sep 2025 (actual)
- Primary completion
- 31 Dec 2030 (estimated)
- Study completion
- 31 Dec 2030 (estimated)
- First posted
- 8 Aug 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Research Proposal: Evaluating the Effectiveness of the OrthoApnea NOA Dental Appliance in Treating Obstructive Sleep Apnea (OSA)
- Purpose of the Study This study will evaluate how effective the OrthoApnea NOA dental appliance is at treating patients with mild, moderate, and severe obstructive sleep apnea (OSA). It will also assess the Morning Aligner as a supporting tool to maintain jaw alignment and comfort. In addition to following patients prospectively over three years, this study will also analyze and compare pre-existing clinical data from other patients who have used different nylon-based mandibular advancement devices. This approach will allow us to assess relative performance in terms of treatment outcomes, comfort, and long-term adherence.
- Hypothesis The OrthoApnea NOA, used with the Morning Aligner, will reduce the Apnea-Hypopnea Index (AHI) by at least 50%, with a goal of bringing AHI to fewer than 5 events per hour in many patients. Compared to other nylon-based dental appliances, the NOA will show: Better long-term efficacy Longer retention time (device durability) Higher adherence to treatment Improved patient comfort and satisfaction
- Justification Dental sleep appliances are a valuable alternative for patients who cannot tolerate continuous positive airway pressure (CPAP) therapy. The OrthoApnea NOA is a custom-made, modern appliance designed for maximum comfort, adjustability, and effectiveness. Including the Morning Aligner in the treatment may enhance comfort and prevent bite changes. There is currently limited long-term real-world data comparing this device with other nylon-based appliances. This study aims to fill that gap by evaluating both new patients and historical patient data, providing robust evidence to support treatment decisions.
- Objectives Primary Objective To evaluate whether the OrthoApnea NOA reduces AHI by ≥50%, with a goal of achieving <5 events per hour. Secondary Objectives Measure improvements in: AHI (Apnea-Hypopnea Index) CT90 (percentage of time with oxygen saturation below 90%) BMI (body mass index) Epworth Sleepiness Scale (ESS) scores Device retention/durability Jaw alignment and dental comfort Patient adherence and satisfaction
- Study Design and Methods Design Quasi-experimental, comparative longitudinal study Two groups: Prospective cohort using the OrthoApnea NOA + Morning Aligner Retrospective cohort of patients treated with other nylon-based oral appliances (existing clinic data) Sample Total Sample Size: 250 Intervention Sample Size: 100 patients in the prospective NOA group Historical Comparison Group: 100-150 matched patients from prior records Sample Size and Power Calculation Calculated using the Harvard Hedwig sample size calculator sing a 2 sided alpha of 0.05, power of 0.9 with a standard deviation of 10 and a difference in means of 5 and a dropout rate of approximately 20% for the prospective group
- Data Collection and Follow-up Prospective Group (OrthoApnea NOA + Morning Aligner): Sleep studies at baseline, 6, 12, 18, 24, and 36 months CT90, BMI, ESS, and dental/jaw evaluations Patient questionnaires on comfort, satisfaction, and adherence Device assessments for wear and retention Retrospective Group (Other nylon appliances): Extract AHI, CT90, BMI, ESS, and device durability from patient records Match based on age, gender, OSA severity, and BMI
- Data Analysis Plan Primary Analysis
Compare changes in AHI from baseline to follow-up between the NOA group and retrospective nylon appliance group using:
Independent t-tests or ANCOVA for continuous variables (adjusting for baseline values)
Chi-square tests for categorical outcomes (e.g., proportion of patients achieving AHI < 5)
Secondary Analyses Longitudinal trends in AHI, CT90, ESS, and BMI using mixed-effects models
Analysis of device durability and patient adherence using survival analysis or time-to-event methods
Evaluate correlations between adherence, comfort, and clinical improvement
Subgroup analysis by OSA severity (mild, moderate, severe)
Data Matching and Control
Retrospective data will be matched to prospective participants based on:
Age Sex Baseline AHI category BMI Propensity score matching may be used for more accurate comparisons
This study combines real-world clinical data with a prospective follow-up to evaluate the long-term effectiveness of the OrthoApnea NOA appliance and its companion Morning Aligner. It will provide strong, comparative evidence of its performance against other nylon-based devices in terms of sleep improvement, patient comfort, and adherence-information that is critically needed for guiding future treatment recommendations in dental sleep medicine.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- adults with OSA
Key inclusion criteria (1 listed)
- Dxed OSA being treated with NOA appliance
Key exclusion criteria (1 listed)
- no OSA Dx
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
AHI
Time frame: 3 years
Disease Index
1 secondary outcome
Side Effects
Time frame: 3 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Feb 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Obstructive Sleep Apnea, run by University of Alberta at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 10 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Primary Investigator ((780) 492-7696, airwayresearchdsm@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
AHI (time frame: 3 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Feb 2026.