Efficacy of a Novel MAD in OSA

Summary

Oral appliances (OA) have emerged as an alternative to continuous positive airway pressure (CPAP) for obstructive sleep apnea (OSA) treatment. The most commonly used OA reduces upper airway collapse by advancing the mandible (mandibular advancement devices, MAD).

There is a strong evidence base demonstrating that MADs improve OSA in the majority of patients, including some with more severe disease. However, MADs are not efficacious for all, with approximately one-third of patients experiencing no therapeutic benefit. Patients often prefer MADs to gold-standard CPAP treatment. Head-to-head trials confirm CPAP is superior in reducing OSA parameters on polysomnography; however, this greater efficacy does not necessarily translate into better health outcomes in clinical practice. Comparable effectiveness of MADs and CPAP has been attributed to higher reported nightly use of MADs, suggesting that inferiority in reducing apnoeic events may be counteracted by greater treatment adherence.

The MAD in study, called Bite-Velo Linguale (BVL), features a novel monobloc device including a tongue retainer, a suction cavity that maintains the tongue down onto the mouth floor in order to prevent it from raising towards the hard palate, and therefore increasing the retro lingual aerial space. Its design requires the presence of only four occlusal points, allowing for a direct anchorage onto the mandibular bone, thus reducing the risk for occlusal changes, tooth loosening and the development of an anterior cross bite, which represent some of the major long-term adverse effects of oral appliances.

MADs are generally well tolerated, although short-term adverse effects during acclimatization are common. Long-term dental changes do occur, but these are for the most part subclinical and do not preclude continued use. The BVL in study features technological advances aimed at preventing long-term dental changes, as well as improving tolerability and easiness of use.

Conditions

• Sleep Apnea, Obstructive
• Apnea, Obstructive
• OSA
• OSAH
• Obstructive Sleep Apnea
• Obstructive Sleep Apnea Syndrome

Interventions

DEVICE

Velo-Lingual Bite (BVL)

The administration of the device will proceed according to both the essential requirements of the European directives concerning medical devices (Annex I and X of directive 93/42/EEC) and the clinical practice standards and guidelines provided by the AASM and AASDM. These include the obtainment of alginate impression of both jaws and an interocclusal record, with the mandible at 50% of its maximal protrusive position. Since no single standard titration protocol is available, progressive mandibular advancement will be conducted according to the best available medical standard.

Sponsors & Collaborators

• Mauro Manconi

  lead OTHER

Principal Investigators

• Mauro Manconi, MD, PhD · Sleep and Epilepsy Center, Neurocenter of Southern Switzerland, Ospedale Civico di Lugano, Ente Ospedaliero Cantonale

Study Design

Allocation

NA

Purpose

TREATMENT

Masking

NONE

Model

SINGLE_GROUP

Eligibility

Min Age

18 Years

Max Age

65 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2017-05-10

Primary Completion

2018-10-18

Completion

2018-10-18

Countries

• Switzerland

Study Locations