Open Label Pilot Exploratory Study of a New Mandibular Oral Device for Mild to Moderate Obstructive Sleep Apnea: The BVL Project
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Mauro Manconi
- Enrollment
- 21
- Locations
- 2
- Primary Endpoint
- Reduction in pathological breathing events
Study Overview
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.
Detailed Description
The MAD in study features a novel monobloc device including a tongue retainer, a suction cavity to push the tongue down onto the mouth floor, thus preventing its lifting towards the hard palate, which improves retro lingual dimensions. 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 the major long-term adverse effects of oral appliances.
MADs, as well as CPAP, represent the first choice treatment for mild-to-moderate OSAH. In several countries, as well as in Switzerland, health insurances cover the costs of MAD production in patients with mild-to-moderate OSAH or in severe OSAH patients who did not tolerate CPAP previously (as specified in the federal Mittel und Gegenständeliste (MiGeL), Position L 23.26.01.00.1).
Three main novelties justify the experimentation of this new MAD: a monobloc design, the combination with a tongue retainer and a potential future lower cost of production compared to the devices available on the market today.
The device will be designed, manufactured and used under the conditions and for the purposes intended. Thus, it will not compromise the clinical condition or the safety of patients, or the safety and health of users or, where applicable, other persons. Any risks, which may be associated with its intended use, constitute acceptable risks when weighed against the benefits to the patient and are compatible with a high level of protection of health and safety.
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.
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to 65 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •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
Exclusion Criteria
- •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)
Outcomes
Primary Outcomes
Reduction in pathological breathing events
Time Frame: Weeks 9 to 10
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.
Secondary Outcomes
- Treatment-Emergent Side effects(At weeks 5, 7, 8, 9, 11)
- Modification in T90(Weeks 9 to 10)
- Satisfaction with the device(At weeks 5, 7, 8, 9, 11)
- Modification in NREM AHI(Weeks 9 to 10)
- Modification in ODI≥3%(Weeks 9 to 10)
- Modification in TST(Weeks 9 to 10)
- Modification in WASO(Weeks 9 to 10)
- Usage (number of nights/week)(At weeks 5, 7, 8, 9, 11)
- Modification in supine AHI(Weeks 9 to 10)
- Modification in SE(Weeks 9 to 10)
- Usage (number of hours/night)(At weeks 5, 7, 8, 9, 11)
- Pain(At weeks 5, 7, 8, 9, 11)
- Modification in REM AHI(Weeks 9 to 10)
- Modification in SL(Weeks 9 to 10)
- Modification in global AHI(Weeks 9 to 10)
- Modification in RDI(Weeks 9 to 10)
- Modification in snoring time(Weeks 9 to 10)
Investigators
Mauro Manconi
Head of Sleep and Epilepsy Center
Ente Ospedaliero Cantonale, Bellinzona