OrthoApnea NOA® for Obstructive Sleep Apnea

Overseen By Isabel Moreno Hay

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Isabel Moreno Hay

Disqualifiers: Sleep disorders, Periodontal disease, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 8

Duration: 16 weeks

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new device called the Orthoapnea NOA® to determine its effectiveness for people with obstructive sleep apnea, a condition where breathing stops and starts during sleep. Researchers aim to compare this device's performance and comfort to other similar devices. The trial seeks participants diagnosed with obstructive sleep apnea who have not used a similar device before and have at least eight teeth on both the top and bottom rows of their mouth. As an unphased trial, this study allows participants to contribute to innovative research that could enhance sleep apnea treatment options.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications.

What prior data suggests that the Orthoapnea NOA® mandibular advancement device is safe for managing obstructive sleep apnea?

Research shows that the Orthoapnea NOA® device helps people with mild to moderate obstructive sleep apnea (OSA) breathe better while sleeping. It gently moves the lower jaw forward to keep the airway open. Studies have found that people generally tolerate these devices well.

Although specific safety data is not provided here, the FDA has approved the Orthoapnea NOA® for use in people with OSA, indicating it is considered reasonably safe for this condition. Some individuals might experience jaw discomfort or issues with the temporomandibular joint (TMJ), but these side effects are usually mild and resolve on their own.

Prospective trial participants should consider how they typically adjust to new devices and discuss any concerns with the trial team. ^{1 2 3 4 5}

Why are researchers excited about this trial?

The OrthoApnea NOA® is unique because it offers a custom-made solution specifically designed for each individual with obstructive sleep apnea. Unlike traditional continuous positive airway pressure (CPAP) machines that require wearing a mask and can be uncomfortable for some, this mandibular advancement device is tailored to fit comfortably in the mouth, making it easier to use consistently. Researchers are excited about this treatment because it provides a non-invasive option that could improve comfort and adherence, potentially leading to better management of sleep apnea symptoms.

What evidence suggests that the Orthoapnea NOA® device is effective for managing obstructive sleep apnea?

Research has shown that the Orthoapnea NOA® device, used by participants in this trial, can help treat obstructive sleep apnea (OSA). The device gently moves the lower jaw forward to keep the airway open, improving breathing during sleep. Users of the NOA® device have reported better sleep and fewer interruptions in breathing. Studies also indicate that most users are satisfied with the device and experience only minor side effects. Overall, these findings suggest that the Orthoapnea NOA® is a promising option for managing OSA. ^{2 6 7 8 9}

Who Is on the Research Team?

Isabel Moreno Hay

Principal Investigator

University of Kentucky

Are You a Good Fit for This Trial?

Inclusion Criteria

No history of previous use of a MAD.

You have given informed consent to participate in the study.\n

Informed consent to participate in the study

Exclusion Criteria

You have been diagnosed with sleep disorders like trouble sleeping, excessive sleepiness, restless legs, or acting out dreams during sleep.

You have a very sensitive gag reflex.

Inadequate English comprehension

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive a custom-made NOA® mandibular advancement device, with adjustments every 2 weeks to achieve maximum therapeutic benefit

16 weeks

8 visits (in-person)

Follow-up

Participants are monitored for compliance, sleep parameters, pain, headaches, TMD, and side effects

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Orthoapnea NOA®

How Is the Trial Designed?

Group I: MAD therapy Experimental Treatment 1 Intervention

An NOA® appliance (Orthoapnea S.L., Malaga, Spain) was custom made for each participant at 50% from maximum protrusion.

Who Is Running the Clinical Trial?

Isabel Moreno Hay

Lead Sponsor

Trials

2

Recruited

50+

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC9222002/

Pilot Study of a New Mandibular Advancement Device - PMC This study was conducted to determine the efficacy of a customized mandibular advancement device (MAD) in the treatment of obstructive sleep apnea (OSA).

2. clinicaltrials.gov clinicaltrials.gov/study/NCT05139303?term=noa&viewType=Table&rank=1&checkSpell=

Efficacy of the OrthoApnea NOA® Mandibular ... The objective of this study is to assess the efficacy of the Orthoapnea NOA ® mandibular advancement device and describe the percentage of advancement (%) ...

3. clinicaltrials.gov clinicaltrials.gov/study/NCT07111962

NCT07111962 | Effectiveness of NOA OATMAD This study combines real-world clinical data with a prospective follow-up to evaluate the long-term effectiveness of the OrthoApnea NOA ...

4. tandfonline.com tandfonline.com/doi/abs/10.1080/08869634.2025.2461657

Efficacy of the NOA® mandibular advancement device in ... The NOA® device demonstrated high efficacy, improved patient-reported outcomes, and caused no significant side effects or issues.

5. orthoapnea.com orthoapnea.com/en/clinical-studies/

Clinical studies Efficacy of the NOA® mandibular advancement device in the management of obstructive sleep apnea: A cohort study​. Diego Fernandez-Vial, Ian Boggero, Sara ...

6. accessdata.fda.gov accessdata.fda.gov/cdrh_docs/pdf20/K202651.pdf

February 12, 2021 Orthoapnea S.L. Jose Repolles Llecha ... NOA SLEEP APNEA AND SNORING DEVICE is a mandibular advance device (MAD) indicated for mild to moderate obstructive sleep apnea (OSA) and to ...

7. accessdata.fda.gov accessdata.fda.gov/cdrh_docs/pdf20/K203477.pdf

February 25, 2021 Orthoapnea S.L. Jose Llecha Managing ... Classic device consists of two splints united to each other by a screw that allows controlled advancement of the mandible by the increase of the ...

8. orthoapnea.com orthoapnea.com/en/orthoapnea-noa/

OrthoApnea NOA OrthoApnea NOA is a unique mandibular advancement device, developed completely digitally and customized to fit each patient's unique mandibular biomechanics.

9. clinicaltrials.gov clinicaltrials.gov/study/NCT05139303?term=AREA%5BBasicSearch%5D(noa)&rank=1&tab=results

Study Results | NCT05139303 | Efficacy of the OrthoApnea ... Therapeutic failure will be established when at 100% of advancement of the device, there is less than 50% of reduction of the AHI/RDI with a residual AHI/RDI >5 ...