- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05139303
Efficacy of the OrthoApnea NOA® Mandibular Advancement Device in the Management of Obstructive Sleep Apnea.
September 29, 2023 updated by: Isabel Moreno Hay
Efficacy of the OrthoApnea NOA® Mandibular Advancement Device in the Management of Obstructive Sleep Apnea. Clinical Trial and Retrospective Comparison Study.
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
37
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Kentucky
-
Lexington, Kentucky, United States, 40536
- Orofacial Pain Center
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 79 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Description
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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: MAD therapy
|
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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
To assess the efficacy of the Orthoapnea NOA® mandibular advancement device and describe the percentage of advancement (%) needed to reach efficacy.
Time Frame: 16 weeks.
|
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.
|
To retrospectively compare with other MAD designs.
Time Frame: 16 weeks.
|
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 Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Describe patient compliance and adherence to the therapy with the Orthoapnea NOA® device.
Time Frame: 16 weeks.
|
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.
|
Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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.
Time Frame: 16 weeks.
|
The presence of signs, symptoms of TMD will be assessed following the Diagnostic Criteria for Temporomandibular Disorders (DC/TMD).
|
16 weeks.
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Isabel Moreno Hay, University of Kentucky
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
November 15, 2021
Primary Completion (Actual)
August 2, 2023
Study Completion (Actual)
August 2, 2023
Study Registration Dates
First Submitted
November 4, 2021
First Submitted That Met QC Criteria
November 17, 2021
First Posted (Actual)
December 1, 2021
Study Record Updates
Last Update Posted (Actual)
October 2, 2023
Last Update Submitted That Met QC Criteria
September 29, 2023
Last Verified
September 1, 2023
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 71295
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
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
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Obstructive Sleep Apnea
-
LivaNovaRecruitingApnea | Obstructive Sleep Apnea | OSA | Apnea, Obstructive | Apnea+Hypopnea | Apnea, Obstructive Sleep | Hypopnea, SleepUnited States
-
Mauro ManconiCompletedObstructive Sleep Apnea Syndrome | Sleep Apnea, Obstructive | Obstructive Sleep Apnea | OSA | Apnea, Obstructive | OSAHSwitzerland
-
University of California, Los AngelesRecruiting
-
Brigham and Women's HospitalCompletedObstructive Sleep Apnea (OSA)United States
-
State Budgetary Healthcare Institution, National...RecruitingObstructive Sleep Apnea | Obstructive Sleep Apnea-hypopnea | Obstructive Sleep Apnea-hypopnea SyndromeRussian Federation
-
The Hospital for Sick ChildrenCompleted
-
Cryosa, Inc.Active, not recruitingObstructive Sleep Apnea of AdultPanama, Paraguay
-
State Key Laboratory of Respiratory DiseaseCompletedObstructive Sleep Apnea of AdultChina
-
Somnics, Inc.UnknownObstructive Sleep Apnea of AdultTaiwan
-
ApnimedCompletedOSA - Obstructive Sleep ApneaUnited States
Clinical Trials on Orthoapnea NOA®
-
Toray Industries, IncRecruitingAcute Respiratory Distress SyndromeJapan
-
Dong-A ST Co., Ltd.CompletedFunctional DyspepsiaKorea, Republic of
-
Galderma R&DCompletedAtopic DermatitisPhilippines, China
-
Chong Kun Dang PharmaceuticalCompleted
-
Sanofi Pasteur, a Sanofi CompanyCompletedPertussis | Diphtheria | PolioUnited States
-
Chung-Ang University Hosptial, Chung-Ang University...UnknownFunctional DyspepsiaKorea, Republic of
-
Amir AzarpazhoohInstitut Straumann AGCompletedPeriodontal Inflammation | Crown LengtheningCanada
-
Novartis PharmaceuticalsCompletedPulmonary Disease, Chronic Obstructive (COPD)Argentina
-
GuerbetCompletedPrimary Brain TumorColombia, Korea, Republic of, United States, Mexico