Back to resultsEfficacy of the OrthoApnea NOA® Mandibular Advancement Device in the Management of Obstructive Sleep Apnea.
Primary Purpose
Obstructive Sleep Apnea
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Orthoapnea NOA®
Sponsored by
About this trial
This is an interventional treatment trial for Obstructive Sleep Apnea focused on measuring OSA, Obstructive sleep apnea, mandibular advancement device, oral appliance
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.
Sites / Locations
- Orofacial Pain Center
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
MAD therapy
Arm Description
Outcomes
Primary Outcome Measures
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.
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.
Secondary Outcome Measures
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.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT05139303
Brief Title
Efficacy of the OrthoApnea NOA® Mandibular Advancement Device in the Management of Obstructive Sleep Apnea.
Official Title
Efficacy of the OrthoApnea NOA® Mandibular Advancement Device in the Management of Obstructive Sleep Apnea. Clinical Trial and Retrospective Comparison Study.
Study Type
Interventional
2. Study Status
Record Verification Date
September 2023
Overall Recruitment Status
Completed
Study Start Date
November 15, 2021 (Actual)
Primary Completion Date
August 2, 2023 (Actual)
Study Completion Date
August 2, 2023 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Isabel Moreno Hay
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
No
5. Study Description
Brief 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Obstructive Sleep Apnea
Keywords
OSA, Obstructive sleep apnea, mandibular advancement device, oral appliance
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
37 (Actual)
8. Arms, Groups, and Interventions
Arm Title
MAD therapy
Arm Type
Experimental
Intervention Type
Device
Intervention Name(s)
Orthoapnea NOA®
Intervention Description
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.
Primary Outcome Measure Information:
Title
To assess the efficacy of the Orthoapnea NOA® mandibular advancement device and describe the percentage of advancement (%) needed to reach efficacy.
Description
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.
Time Frame
16 weeks.
Title
To retrospectively compare with other MAD designs.
Description
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.
Time Frame
16 weeks.
Secondary Outcome Measure Information:
Title
Describe patient compliance and adherence to the therapy with the Orthoapnea NOA® device.
Description
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.
Time Frame
16 weeks.
Other Pre-specified Outcome Measures:
Title
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.
Description
The presence of signs, symptoms of TMD will be assessed following the Diagnostic Criteria for Temporomandibular Disorders (DC/TMD).
Time Frame
16 weeks.
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
79 Years
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Isabel Moreno Hay
Organizational Affiliation
University of Kentucky
Official's Role
Principal Investigator
Facility Information:
Facility Name
Orofacial Pain Center
City
Lexington
State/Province
Kentucky
ZIP/Postal Code
40536
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Efficacy of the OrthoApnea NOA® Mandibular Advancement Device in the Management of Obstructive Sleep Apnea.
We'll reach out to this number within 24 hrs