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
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.
Contacts
Jennifer Cobb
Immunology at National Institute of Allergy and Infectious Diseases (NIAID)
Locations
Lexington, Kentucky, United States
Patients applied
Trial Officials
Isabel Moreno Hay
Principal Investigator
University of Kentucky
Timeline
First submit
Trial launched
Trial updated
Estimated completion
Not reported
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