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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.
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 protocol recommended by the manufacturer. Maximum mouth opening was measured by adding the interincisal distance to the overbite (in millimeters, using TheraBite® Range of Motion ruler, Great Lakes Dental Technologies, Tonawanda, NY, USA). The MAD was fabricated at an initial protrusion of 50%, with subsequent progressive mandibular components of additional 10% of protrusion up to 100% of the maximum protrusive range. Lastly, a full coverage morning deprogrammer (TAP® AM Aligner, World Class Technology Corp., McMinniville, OR, USA) was fabricated for all the participants to be used for 10 minutes upon removal of the MAD. Follow up visits were scheduled every two weeks and measures of compliance, sleep parameters, pain, headaches, TMD and side effects were monitored.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| MAD therapy | Experimental | An NOA® appliance (Orthoapnea S.L., Malaga, Spain) was custom made for each participant at 50% from maximum protrusion. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Orthoapnea NOA® | Device | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| To Assess the Number of Participants That Responded to the Mandibular Advancement Device (MAD) | Assessment of efficacy of the device: After delivery, the MAD will be advanced 10% every 2 weeks until maximum therapeutic benefit. Sleep parameters (apnea hypopnea index (AHI) and minimum oxygen saturation) will be extracted from the initial polysomnography (PSG), and from a final confirmatory home sleep apnea test. The efficacy will be stablished based on: Criterion I: > 50% reduction of AHI; Criterion II: AHI < 5 events/hour or <15 events/hour with a significant reduction of obstructive sleep apnea (OSA) associated symptoms. | 16 weeks. |
| % 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 | 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. | 16 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants Compliant to the Mandibular Advancement Device (MAD) | The self-reported use of mandibular advancement device (MAD) was assessed at each follow-up via questionnaire on a five-point checklist (number hours per night and nights per week). Compliance was defined as wearing the appliance for ≥4 hours per night during at least 70% of the nights. | 16 weeks. |
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of Temporomandibular Disorders (TMD) Associated to the Use of the Mandibular Advancement Device (MAD). the Use of the Orthoapnea NOA® Mandibular Advancement Device. | Number of participants that develop of signs, symptoms of TMD will be assessed following the Diagnostic Criteria for Temporomandibular Disorders (DC/TMD). | 16 weeks. |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Isabel Moreno Hay | University of Kentucky | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Orofacial Pain Center | Lexington | Kentucky | 40536 | United States |
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4 participants were excluded, three of them did not report back to their follow up appointment and one could not tolerate the intervention.
Participants were recruited consecutively from patients referred to the Orofacial Pain Clinic for the management of obstructive sleep apnea.
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| ID | Title | Description |
|---|---|---|
| FG000 | MAD Therapy | 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. |
| FG001 | Retrospective MAD | Archival data were extracted from a database of patients that started MAD therapy for OSA between January of 2010 and August of 2021 at the same clinic and that had a second sleep study performed to assess the effectiveness of the MAD. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | MAD Therapy | 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. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | To Assess the Number of Participants That Responded to the Mandibular Advancement Device (MAD) | Assessment of efficacy of the device: After delivery, the MAD will be advanced 10% every 2 weeks until maximum therapeutic benefit. Sleep parameters (apnea hypopnea index (AHI) and minimum oxygen saturation) will be extracted from the initial polysomnography (PSG), and from a final confirmatory home sleep apnea test. The efficacy will be stablished based on: Criterion I: > 50% reduction of AHI; Criterion II: AHI < 5 events/hour or <15 events/hour with a significant reduction of obstructive sleep apnea (OSA) associated symptoms. | Posted | Number | participants | 16 weeks. |
|
From enrollment to the end of treatment at week 16. Participants were assessed every visit (every 2 weeks) from delivery of the mandibular advancement device until the end of follow up (week 16).
The use of mandibular advancement devices for the management of obstructive sleep apnea are non invasive and reversible; adverse event data were not collected from the retrospective MAD group
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | MAD Therapy | 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. |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Jaw pain upon use of the mandibular advancement device | Musculoskeletal and connective tissue disorders | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Isabel Moreno Hay | University of Kentucky College of Dentistry Division of Orofacial Pain | 8593233440 | imo226@uky.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Feb 3, 2023 | Aug 1, 2024 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D020181 | Sleep Apnea, Obstructive |
| ID | Term |
|---|---|
| D012891 | Sleep Apnea Syndromes |
| D001049 | Apnea |
| D012120 | Respiration Disorders |
| D012140 | Respiratory Tract Diseases |
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|
| BG001 | Retrospective MAD | Archival data were extracted from a database of patients that started MAD therapy for OSA between January of 2010 and August of 2021 at the same clinic and that had a second sleep study performed to assess the effectiveness of the MAD. |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
|
| Body Mass Index (BMI) | Body Mass Index (BMI) is calculated by using weight in kilograms (kg) divided by the square of height in meters (m2). | Mean | Standard Deviation | kg/m^2 |
|
| Apnea Hypopnea Index (AHI) | Apnea Hypopnea Index (AHI) is calculated by adding the total amount of apneas and hypopneas during the study and dividing that number by total sleep time. | Mean | Standard Deviation | events/hour |
|
| Minimum oxygen saturation | A pulse oximeter is used to calculate the minimum oxygen saturation by measuring light wavelengths to determine the ratio of the current levels of oxygenated hemoglobin to deoxygenated hemoglobin. | Mean | Standard Deviation | % of oxygen saturation |
|
| OG001 | Retrospective MAD | Archival data were extracted from a database of patients that started MAD therapy for OSA between January of 2010 and August of 2021 at the same clinic and that had a second sleep study performed to assess the effectiveness of the MAD. |
|
|
|
| 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 | 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. | Number of participants analyzed were those succeeding for Criterion 1 and Criterion 2 | Posted | Mean | Standard Deviation | percentage of mandibular protrusion | 16 weeks |
|
|
|
| Secondary | Number of Participants Compliant to the Mandibular Advancement Device (MAD) | The self-reported use of mandibular advancement device (MAD) was assessed at each follow-up via questionnaire on a five-point checklist (number hours per night and nights per week). Compliance was defined as wearing the appliance for ≥4 hours per night during at least 70% of the nights. | Posted | Count of Participants | Participants | 16 weeks. |
|
|
|
| Other Pre-specified | Incidence of Temporomandibular Disorders (TMD) Associated to the Use of the Mandibular Advancement Device (MAD). the Use of the Orthoapnea NOA® Mandibular Advancement Device. | Number of participants that develop of signs, symptoms of TMD will be assessed following the Diagnostic Criteria for Temporomandibular Disorders (DC/TMD). | Data were not collected from the retrospective study group for this measure | Posted | Count of Participants | Participants | 16 weeks. |
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| 0 |
| 33 |
| 0 |
| 33 |
| 1 |
| 33 |
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| D020919 |
| Sleep Disorders, Intrinsic |
| D020920 | Dyssomnias |
| D012893 | Sleep Wake Disorders |
| D009422 | Nervous System Diseases |
| Criterion II |
|
|