Efficacy of the OrthoApnea NOA® Mandibular Advancement Device in the Management of Obstructive Sleep Apnea.

Not Applicable

Completed

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.

Recruitment & Eligibility

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.

Arm && Interventions

Group	Intervention	Description
MAD therapy	Orthoapnea NOA®	-

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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.