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

NCT ID: NCT05139303

Last Updated: 2024-11-12

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 37 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-11-15
• Study Completion Date: 2023-08-02

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.

Conditions

Obstructive Sleep Apnea

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

MAD therapy

An NOA® appliance (Orthoapnea S.L., Malaga, Spain) was custom made for each participant at 50% from maximum protrusion.

Group Type: EXPERIMENTAL

Orthoapnea NOA®

Intervention Type: 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.

Interventions

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.

Intervention Type: DEVICE

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 79 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Isabel Moreno Hay

OTHER

Sponsor Role: lead

Responsible Party

Isabel Moreno Hay

Assistant Professor

Responsibility Role: SPONSOR_INVESTIGATOR

Principal Investigators

Isabel Moreno Hay

Role: PRINCIPAL_INVESTIGATOR

University of Kentucky

Locations

Orofacial Pain Center

Lexington, Kentucky, United States

Countries

United States

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

71295

Identifier Type: -

Identifier Source: org_study_id