Efficacy of the OrthoApnea NOA® Mandibular Advancement Device in the Management of 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

37 Participants Needed

Trial Summary

What is the purpose of this trial?

This trial is testing a special mouthpiece called the Orthoapnea NOA® to help people with sleep apnea breathe better at night. It moves the lower jaw forward to keep the airway open. The study will also check how well patients stick to using it and if it causes any jaw problems.

Will I have to stop taking my current medications?

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

Research Team

Isabel Moreno Hay

Principal Investigator

University of Kentucky

Eligibility Criteria

Inclusion Criteria

No history of previous use of a MAD.

Age: >18 and <80 years old.

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

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

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

Treatment Details

Interventions

• Orthoapnea NOA®

Participant Groups

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+