Trial Outcomes & Findings for Efficacy of the OrthoApnea NOA® Mandibular Advancement Device in the Management of Obstructive Sleep Apnea. (NCT NCT05139303)

NCT ID: NCT05139303

Last Updated: 2024-11-12

Results Overview

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.

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 37 participants
• Primary outcome timeframe: 16 weeks.
• Results posted on: 2024-11-12

Participant Flow

Participants were recruited consecutively from patients referred to the Orofacial Pain Clinic for the management of obstructive sleep apnea.

4 participants were excluded, three of them did not report back to their follow up appointment and one could not tolerate the intervention.

Participant milestones

Measure	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.	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.
Overall Study STARTED	37	59
Overall Study COMPLETED	33	59
Overall Study NOT COMPLETED	4	0

Reasons for withdrawal

Measure	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.	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.
Overall Study Lost to Follow-up	3	0
Overall Study Adverse Event	1	0

Baseline Characteristics

Race and Ethnicity were not collected from any participant.

Baseline characteristics by cohort

Measure	MAD Therapy n=33 Participants 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.	Retrospective MAD n=59 Participants 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.	Total n=92 Participants Total of all reporting groups
Age, Continuous	52.36 years STANDARD_DEVIATION 15.76 • n=33 Participants	59.03 years STANDARD_DEVIATION 10.31 • n=59 Participants	55.70 years STANDARD_DEVIATION 13.03 • n=92 Participants
Sex: Female, Male Female	21 Participants n=33 Participants	27 Participants n=59 Participants	48 Participants n=92 Participants
Sex: Female, Male Male	12 Participants n=33 Participants	32 Participants n=59 Participants	44 Participants n=92 Participants
Race and Ethnicity Not Collected	—	—	0 Participants Race and Ethnicity were not collected from any participant.
Body Mass Index (BMI)	30.57 kg/m^2 STANDARD_DEVIATION 5.72 • n=33 Participants	31.93 kg/m^2 STANDARD_DEVIATION 7.07 • n=59 Participants	31.25 kg/m^2 STANDARD_DEVIATION 6.40 • n=92 Participants
Apnea Hypopnea Index (AHI)	15.34 events/hour STANDARD_DEVIATION 11.27 • n=33 Participants	23.46 events/hour STANDARD_DEVIATION 16.76 • n=59 Participants	19.40 events/hour STANDARD_DEVIATION 14.02 • n=92 Participants
Minimum oxygen saturation	84.91 % of oxygen saturation STANDARD_DEVIATION 4.36 • n=33 Participants	82.28 % of oxygen saturation STANDARD_DEVIATION 6.42 • n=59 Participants	83.60 % of oxygen saturation STANDARD_DEVIATION 5.39 • n=92 Participants

PRIMARY outcome

Timeframe: 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.

Outcome measures

Measure	MAD Therapy n=33 Participants 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.	Retrospective MAD n=59 Participants 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.
To Assess the Number of Participants That Responded to the Mandibular Advancement Device (MAD) Criterion 1	26 participants	37 participants
To Assess the Number of Participants That Responded to the Mandibular Advancement Device (MAD) Criterion 2	30 participants	20 participants

PRIMARY outcome

Timeframe: 16 weeks

Population: Number of participants analyzed were those succeeding for Criterion 1 and Criterion 2

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.

Outcome measures

Measure	MAD Therapy n=33 Participants 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.	Retrospective MAD n=59 Participants 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.
% 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	88.73 percentage of mandibular protrusion Standard Deviation 14
% 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	89.59 percentage of mandibular protrusion Standard Deviation 15.91

SECONDARY outcome

Timeframe: 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.

Outcome measures

Measure	MAD Therapy n=33 Participants 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.	Retrospective MAD n=59 Participants 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.
Number of Participants Compliant to the Mandibular Advancement Device (MAD)	33 Participants	59 Participants

OTHER_PRE_SPECIFIED outcome

Timeframe: 16 weeks.

Population: Data were not collected from the retrospective study group for this measure

Number of participants that develop of signs, symptoms of TMD will be assessed following the Diagnostic Criteria for Temporomandibular Disorders (DC/TMD).

Outcome measures

Measure	MAD Therapy n=33 Participants 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.	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.
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	—

Adverse Events

MAD Therapy

Serious events: 0 serious events

Other events: 1 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Measure

MAD Therapy n=33 participants at risk 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.

Musculoskeletal and connective tissue disorders Jaw pain upon use of the mandibular advancement device

3.0% 1/33 • Number of events 1 • 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

Additional Information

Dr. Isabel Moreno Hay

University of Kentucky College of Dentistry Division of Orofacial Pain

Phone: 8593233440

Email: imo226@uky.edu

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place