View clinical trials related to OSAH.
Filter by: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.
The purpose of this study is to evaluate the long-term durability of the treatment and safety of the Provent device for those individuals who were enrolled in the C009 study, were diagnosed with obstructive sleep apnea-hypopnea (OSAH), and were actively using the Provent device.
Primary Endpoints: •Comparison of difference in AHI at one-week in-lab polysomnography between "device on" and "device off" nights, controlling for sleep position (supine vs. non-supine) Secondary Endpoints: By polysomnography, reduction in: - AHI with device on vs. off at 3 months, controlling for sleep position - Oxygen desaturation index with device on vs. off - Arousal index with device on vs. off - Duration of snoring with device on vs. off - Epworth Sleepiness Scale Patient acceptance, in terms of: - Refusal rate at screening - Discontinuation rate during follow-up - Daily compliance rate - Device-related adverse events - Serious adverse events