Efficacy of a Novel MAD in OSA

NCT03196583 | Completed DMC

• 1 other identifier: 3184, BASEC 201700317
• Study Type: interventional
• Target: 21
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

obstructive sleep apnea syndrome; video-polysomnography; mandibular advancement device; oral device; cephalometry

Outcome Measures

Primary Outcomes (1)

• Reduction in pathological breathing events

  The primary outcome is the numerical reduction in pathological sleep-related breathing events because of treatment with the BVL, as measured by changes in the AHI.

  Weeks 9 to 10

Secondary Outcomes (17)

• Treatment-Emergent Side effects

  At weeks 5, 7, 8, 9, 11

• Usage (number of nights/week)

  At weeks 5, 7, 8, 9, 11

• Usage (number of hours/night)

  At weeks 5, 7, 8, 9, 11

• Pain

  At weeks 5, 7, 8, 9, 11

• Satisfaction with the device

  At weeks 5, 7, 8, 9, 11

Other Outcomes (3)

• Overall Sleep Quality

  At week 1 and week 11

• Daytime Somnolence

  At week 1 and week 11

• Modification in upper airway volume

  At week 1 and week 11

Study Arms (1)

Single-arm study

EXPERIMENTAL

Velo-Lingual Bite (BVL)

Device: Velo-Lingual Bite (BVL)

Interventions

Velo-Lingual Bite (BVL) DEVICE

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.

Single-arm study

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age between 18 and 65 years old
• VPSG within the last three months
• Diagnosis of mild-to-moderate OSAS (AHI 5-30/h)
• At least 4 teeth present in the lower and upper arch
• Ability to protrude the mandible for at least 6 mm
• Informed Consent

You may not qualify if:

• Significant ENT disease
• Tonsillar hypertrophy
• Uvulopalatopharyngoplasty (UPPP)
• Palatoschisis
• Neoplastic lesions
• Other neurological disorders
• Trigeminal neuralgia
• Myofacial pain dysfunction (MPD)
• Central Sleep Apnea
• Limited mental capacity
• Obesity (BMI \> 30 kg/m2)
• Concomitant sleep-disordered breathing treatment (CPAP and/or positional therapy)

Sponsors & Collaborators

• Mauro Manconi: lead

Study Sites (1)

Sleep and Epilepsy Center, Neurocenter of Southern Switzerland, Ospedale Civico di Lugano, Ente Ospedaliero Cantonale

Lugano, Canton Ticino, 6900, Switzerland

Location

MeSH Terms

Conditions

Sleep Apnea, Obstructive

Condition Hierarchy (Ancestors)

Sleep Apnea Syndromes; Apnea; Respiration Disorders; Respiratory Tract Diseases; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Nervous System Diseases

Study Officials

• Mauro Manconi, MD, PhD

  Sleep and Epilepsy Center, Neurocenter of Southern Switzerland, Ospedale Civico di Lugano, Ente Ospedaliero Cantonale

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Head of Sleep and Epilepsy Center

Model Details: Monocentric, prospective, open-label, interventional, exploratory pilot study.

Study Record Dates

• First Submitted: June 19, 2017
• First Posted: June 23, 2017
• Study Start: May 10, 2017
• Primary Completion: October 18, 2018
• Study Completion: October 18, 2018
• Last Updated: July 1, 2019

Record last verified: 2019-06

Data Sharing

• IPD Sharing: Will not share

Locations

CH (1)