An interventional study of Orthoapnea NOA® in Obstructive Sleep Apnea, sponsored by Isabel Moreno Hay. Completed at 1 site in United States. Open to participants aged 18 Years to 79 Years. Per ClinicalTrials.gov, last updated 2024-11-12.
Sponsored by Isabel Moreno Hay · Not applicable, Interventional, and Treatment
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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This study's enrollment of 37 is below the median of 50 across 965 interventional studies indexed under Apnea.
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Exclusion Criteria:
An NOA® appliance (Orthoapnea S.L., Malaga, Spain) was custom made for each participant at 50% from maximum protrusion.
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.
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.
Time frame: 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.
Time frame: 16 weeks
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.
Time frame: 16 weeks.
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).
Time frame: 16 weeks.
Participants were recruited consecutively from patients referred to the Orofacial Pain Clinic for the management of obstructive sleep apnea.
| Milestone | MAD Therapy | Retrospective MAD |
|---|---|---|
| Started | 37 | 59 |
| Completed | 33 | 59 |
| Not completed | 4 | 0 |
| Withdrew: Lost to follow-up | 3 | 0 |
| Withdrew: Adverse event | 1 | 0 |
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.
| participants | MAD Therapy | Retrospective MAD |
|---|---|---|
| Criterion 1 | 26 | 37 |
| Criterion 2 | 30 | 20 |
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.
| percentage of mandibular protrusion | MAD Therapy | Retrospective MAD |
|---|---|---|
| Criterion I | 80 ± 10.2 | 88.73 ± 14 |
| Criterion II | 75.33 ± 10.08 | 89.59 ± 15.91 |
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.
| Participants | MAD Therapy | Retrospective MAD |
|---|---|---|
| Number of Participants Compliant to the Mandibular Advancement Device (MAD) | 33 | 59 |
Number of participants that develop of signs, symptoms of TMD will be assessed following the Diagnostic Criteria for Temporomandibular Disorders (DC/TMD).
| Participants | MAD Therapy | Retrospective MAD |
|---|---|---|
| Incidence of Temporomandibular Disorders (TMD) Associated to the Use of the Mandibular Advancement Device (MAD). the Use of the Orthoapnea NOA® Mandibular Advancement Device. | 18 | — |
Collected over 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).. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| MAD Therapy | 0/33 (0%) | 0/33 (0%) | 1/33 (3%) |
| Event | MAD Therapy |
|---|---|
| Jaw pain upon use of the mandibular advancement deviceMusculoskeletal and connective tissue disorders | 1/33 |
| Age, Continuous(years) | MAD Therapy | Retrospective MAD | Total |
|---|---|---|---|
| Mean | 52.36 ± 15.76 | 59.03 ± 10.31 | 55.70 ± 13.03 |
| Sex: Female, Male(Participants) | MAD Therapy | Retrospective MAD | Total |
|---|---|---|---|
| Female | 21 | 27 | 48 |
| Male | 12 | 32 | 44 |
| Race and Ethnicity Not Collected(Participants) | MAD Therapy | Retrospective MAD | Total |
|---|---|---|---|
| Count of participants | — | — | 0 |
| Body Mass Index (BMI)(kg/m^2) | MAD Therapy | Retrospective MAD | Total |
|---|---|---|---|
| Mean | 30.57 ± 5.72 | 31.93 ± 7.07 | 31.25 ± 6.40 |
| Apnea Hypopnea Index (AHI)(events/hour) | MAD Therapy | Retrospective MAD | Total |
|---|---|---|---|
| Mean | 15.34 ± 11.27 | 23.46 ± 16.76 | 19.40 ± 14.02 |
| Minimum oxygen saturation(% of oxygen saturation) | MAD Therapy | Retrospective MAD | Total |
|---|---|---|---|
| Mean | 84.91 ± 4.36 | 82.28 ± 6.42 | 83.60 ± 5.39 |
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Isabel Moreno Hay