Obstructive Sleep Apnea
Conditions
Keywords
OSA, Obstructive sleep apnea, mandibular advancement device, oral appliance
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.
Detailed description
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.
Interventions
DEVICEOrthoapnea 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.
Sponsors
Isabel Moreno Hay
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 79 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| To Assess the Number of Participants That Responded to the Mandibular Advancement Device (MAD) | 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 (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. |
| % 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 | 16 weeks | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants Compliant to the Mandibular Advancement Device (MAD) | 16 weeks. | 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. |
Other
| Measure | Time frame | Description |
|---|---|---|
| Incidence of Temporomandibular Disorders (TMD) Associated to the Use of the Mandibular Advancement Device (MAD). the Use of the Orthoapnea NOA® Mandibular Advancement Device. | 16 weeks. | Number of participants that develop of signs, symptoms of TMD will be assessed following the Diagnostic Criteria for Temporomandibular Disorders (DC/TMD). |
Countries
United States
Participant flow
Recruitment details
Participants were recruited consecutively from patients referred to the Orofacial Pain Clinic for the management of obstructive sleep apnea.
Pre-assignment details
4 participants were excluded, three of them did not report back to their follow up appointment and one could not tolerate the intervention.
Participants by arm
| Arm | Count |
|---|---|
| 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. | 33 |
| 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. | 59 |
| Total | 92 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Adverse Event | 1 | 0 |
| Overall Study | Lost to Follow-up | 3 | 0 |
Baseline characteristics
| Characteristic | Retrospective MAD | Total | MAD Therapy |
|---|---|---|---|
| Age, Continuous | 59.03 years STANDARD_DEVIATION 10.31 | 55.70 years STANDARD_DEVIATION 13.03 | 52.36 years STANDARD_DEVIATION 15.76 |
| Apnea Hypopnea Index (AHI) | 23.46 events/hour STANDARD_DEVIATION 16.76 | 19.40 events/hour STANDARD_DEVIATION 14.02 | 15.34 events/hour STANDARD_DEVIATION 11.27 |
| Body Mass Index (BMI) | 31.93 kg/m^2 STANDARD_DEVIATION 7.07 | 31.25 kg/m^2 STANDARD_DEVIATION 6.4 | 30.57 kg/m^2 STANDARD_DEVIATION 5.72 |
| Minimum oxygen saturation | 82.28 % of oxygen saturation STANDARD_DEVIATION 6.42 | 83.60 % of oxygen saturation STANDARD_DEVIATION 5.39 | 84.91 % of oxygen saturation STANDARD_DEVIATION 4.36 |
| Race and Ethnicity Not Collected | — | 0 Participants | — |
| Sex: Female, Male Female | 27 Participants | 48 Participants | 21 Participants |
| Sex: Female, Male Male | 32 Participants | 44 Participants | 12 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 33 |
| other Total, other adverse events | 1 / 33 |
| serious Total, serious adverse events | 0 / 33 |
Outcome results
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.
Time frame: 16 weeks
Population: Number of participants analyzed were those succeeding for Criterion 1 and Criterion 2
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| MAD Therapy | % 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 | 80 percentage of mandibular protrusion | Standard Deviation 10.2 |
| MAD Therapy | % 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 II | 75.33 percentage of mandibular protrusion | Standard Deviation 10.08 |
| Retrospective MAD | % 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 | 88.73 percentage of mandibular protrusion | Standard Deviation 14 |
| Retrospective MAD | % 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 II | 89.59 percentage of mandibular protrusion | Standard Deviation 15.91 |
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.
Time frame: 16 weeks.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| MAD Therapy | To Assess the Number of Participants That Responded to the Mandibular Advancement Device (MAD) | Criterion 1 | 26 participants |
| MAD Therapy | To Assess the Number of Participants That Responded to the Mandibular Advancement Device (MAD) | Criterion 2 | 30 participants |
| Retrospective MAD | To Assess the Number of Participants That Responded to the Mandibular Advancement Device (MAD) | Criterion 1 | 37 participants |
| Retrospective MAD | To Assess the Number of Participants That Responded to the Mandibular Advancement Device (MAD) | Criterion 2 | 20 participants |
p-value: <0.05Chi-squared
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.
Time frame: 16 weeks.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| MAD Therapy | Number of Participants Compliant to the Mandibular Advancement Device (MAD) | 33 Participants |
| Retrospective MAD | Number of Participants Compliant to the Mandibular Advancement Device (MAD) | 59 Participants |
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).
Time frame: 16 weeks.
Population: Data were not collected from the retrospective study group for this measure
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| MAD Therapy | 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 Participants |