ClinConnect ClinConnect Logo
Search / Trial NCT05139303

Efficacy of the OrthoApnea NOA® Mandibular Advancement Device in the Management of Obstructive Sleep Apnea.

Launched by ISABEL MORENO HAY · Nov 17, 2021

Trial Information

Current as of June 22, 2025

Completed

Keywords

Osa Obstructive Sleep Apnea Mandibular Advancement Device Oral Appliance

ClinConnect Summary

Participants were recruited consecutively from patients referred by a board certified sleep physician to the Orofacial Pain Clinic (University of Kentucky, Lexington, Kentucky, USA) for the management of OSA with a mandibular advancement device. An NOA® appliance (Orthoapnea S.L., Malaga, Spain) was custom made for each participant. Digital impressions (scanner 3Shape TRIOS® 3, Copenhagen, Denmark), protrusive records at 50% from maximum protrusion (using a 5 mm fork and George GaugeTM, Great Lakes Dental Technologies, Tonawanda, NY, USA), and clinical pictures were obtained following the p...

Gender

ALL

Eligibility criteria

  • Inclusion Criteria:
  • Age: \>18 and \<80 years old.
  • No history of previous use of a MAD.
  • Diagnosis of OSA by a sleep physician based on a PSG or HSAT (done \>12 months before evaluation date or \> 12 months with \>10% variation of BMI).
  • Upon clinical examination: \>8 teeth per arch; range of anteroposterior mandibular mobility \>5 mm.
  • Informed consent to participate in the study.
  • Exclusion Criteria:
  • Patients with concomitant diagnosed sleep disorders (i.e. insomnia, narcolepsy, restless legs syndrome, rapid eye movement sleep behavior disorder).
  • History of previous allergic reaction to the appliance material (Polyamide 12).
  • Patients using combination therapy for the management of OSA (i.e. PAP therapy or positional therapy).
  • Upon clinical examination: periodontal disease (\>4 mm on periodontal probing, with bleeding on probing, visual signs of periodontal inflammation); tooth horizontal mobility \>1 mm, vertical mobility, and unfavorable crown to root ratio; open cavities, loose or fractured restorations, or patient undergoing restorative dental treatments.
  • Exaggerated gag reflex.
  • Lack of coordination or dexterity.
  • Inadequate English comprehension.

About Isabel Moreno Hay

Isabel Moreno Hay is a dedicated clinical trial sponsor with a focus on advancing medical research and improving patient outcomes. With expertise in designing and managing clinical studies, the organization emphasizes ethical practices, rigorous scientific methodologies, and collaboration with healthcare professionals. Committed to innovation and excellence, Isabel Moreno Hay aims to facilitate the development of new therapies and treatments across various therapeutic areas, ensuring that patient safety and data integrity remain paramount throughout the research process.

Locations

Lexington, Kentucky, United States

Patients applied

0 patients applied

Trial Officials

Isabel Moreno Hay

Principal Investigator

University of Kentucky

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported

Similar Trials