N/A
N=96
Efficacy of the OrthoApnea NOA® Mandibular Advancement Device in the Management of Obstructive Sleep Apnea.
Obstructive Sleep Apnea
Bottom Line
View on ClinicalTrials.gov: NCT05139303 ↗Enrolled (actual)
96
Serious AEs
0.0%
Results posted
Nov 2024
Primary outcome: Primary: To Assess the Number of Participants That Responded to the Mandibular Advancement Device (MAD) — 26; 37; 30; 20 participants — p=<0.05
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Orthoapnea NOA® (Device)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Isabel Moreno Hay
- Primary completion
- Aug 2023
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY To Assess the Number of Participants That Responded to the Mandibular Advancement Device (MAD) |
26; 37; 30; 20 | <0.05 sig |
| PRIMARY % of Advancement of the Jaw Needed to Achieve Efficacy With the Use of the Mandibular Advancement Device (MAD) Based on the Success Criterion I and II |
80; 88.73; 75.33; 89.59 | — |
| SECONDARY Number of Participants Compliant to the Mandibular Advancement Device (MAD) |
33; 59 | — |
Summary
The objective of this study is to assess the efficacy of the Orthoapnea NOA® mandibular advancement device and describe the percentage of advancement (%) needed to reach efficacy, and to retrospectively compare with other MAD designs in the management of obstructive sleep apnea. Additionally, to describe patient compliance and adherence to the therapy with the Orthoapnea NOA® device, and to assess the incidence and prevalence of signs, symptoms, and diagnosis of temporomandibular disorders (TMD) associated to the use of the Orthoapnea NOA® mandibular advancement device.
Eligibility Criteria
Inclusion Criteria
- Age: >18 and 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.
Data sourced from ClinicalTrials.gov (NCT05139303). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.