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

Obstructive Sleep Apnea Clinical Trial

Official title:

Efficacy of the OrthoApnea NOA® Mandibular Advancement Device in the Management of Obstructive Sleep Apnea. Clinical Trial and Retrospective Comparison Study.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05139303
• Other study ID #: 71295
• Status: Completed
• Phase: N/A
• Start date: November 15, 2021
• Est. completion date: August 2, 2023

Study information

• Verified date: September 2023
• Source: University of Kentucky
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 37
• Est. completion date: August 2, 2023
• Est. primary completion date: August 2, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 79 Years

Eligibility

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.

Related Conditions & MeSH terms

• Apnea
• Obstructive Sleep Apnea
• Sleep Apnea Syndromes
• Sleep Apnea, Obstructive

Intervention

Device:
• Orthoapnea NOA®
The efficacy of the appliance for the management of OSA will be stablished based on two criteria. Criterion I: > 50% reduction of AHI/RDI. Criterion II: AHI/RDI < 5 events/hour or <15 events/hour with a significative reduction of OSA associates symptoms as defined before. 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 events/hour with OSA associates symptoms.

Locations

Country	Name	City	State
United States	Orofacial Pain Center	Lexington	Kentucky

Sponsors (1)

Lead Sponsor	Collaborator
Isabel Moreno Hay

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	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.	The presence of signs, symptoms of TMD will be assessed following the Diagnostic Criteria for Temporomandibular Disorders (DC/TMD).	16 weeks.
Primary	To assess the efficacy of the Orthoapnea NOA® mandibular advancement device and describe the percentage of advancement (%) needed to reach efficacy.	Assessment of efficacy of the device: After delivery, the MAD will be advanced 10% every 2 weeks until maximum therapeutic benefit. Sleep parameters (AHI, RDI, min. and average oxygen saturation) will be extracted from the initial PSG, and from a final confirmatory home sleep apnea test. The efficacy will be stablished based on: Criterion I: > 50% reduction of AHI/RDI; Criterion II: AHI/RDI < 5 events/hour or <15 events/hour with a significant reduction of OSA associates symptoms.	16 weeks.
Primary	To retrospectively compare with other MAD designs.	Retrospective comparison with other MAD designs: Archival data will be extracted from records of patients that started MAD therapy for OSA at the same center between 01/01/2010-08/17/2021, and that had a second sleep study performed to assess the effectiveness of the MAD. Data regarding demographic characteristics (age (years), gender (male, female), BMI (kg/m²) and OSA diagnosis (mild, moderate, and severe)), sleep parameters (AHI (events/hour), RDI (events/hour), minimum and average oxygen saturation (%)), level of advancement of the MAD (%), and compliance (nights of use per week) of use will be extracted.	16 weeks.
Secondary	Describe patient compliance and adherence to the therapy with the Orthoapnea NOA® device.	The self-reported use of MAD will be assessed at each follow-up via questionnaire on a five-point checklist (number hours per night and nights per week). Compliance will be defined as wearing the appliance for =4 hours per night during at least 70% of the nights.	16 weeks.