Apnea Syndrome Clinical Trial
Official title:
Comparison of Efficacy of Two Mandibular Advancement Devices (MADs) and Insights Gain From Analysis of Mandibular Behavior During Sleep
Mandibular Advancement Devices (MADs) are now a reliable alternative to continuous positive airway pressure (CPAP) treatments for Obstructive Sleep Apnea (OSA) . Despite good tolerance and efficacy, there are still barriers limiting the widespread use of MAD and its acceptance in OSA routine clinical practice. Various MAD designs currently exist and constantly emerge on the market without clear evidence regarding the best technical choice and the cost-effectiveness compromise. Although these MAD has been tested in term of efficacy, no study has tested the difference between MADs in term of efficacy, tolerance and patient satisfaction. The aim of this clinical trial is to compare the effectiveness of two MADs - custom-made titratable MAD (NarvalTM) and customizable titratable MAD (TALITM), over a 3-month period, in patients with obstructive sleep apnea (OSA).
Obstructive Sleep Apnea (OSA) is characterized by repetitive episodes of partial or complete
pharyngeal obstruction during sleep. OSA is one of the most frequent chronic diseases with
both social and multi-organ consequences making it an economic burden for society. OSA
durably impairs the quality of life of patients and their entourage and is associated with
co-morbidities including hypertension, arrhythmias, stroke, coronary heart disease and
metabolic dysfunction.
Continuous positive airway pressure (CPAP), the first line therapy for OSA, requires high
adherence to be effective in terms of symptom improvement and reduction of the burden of
co-morbidities. For one third of patients, such adherence is difficult to achieve in the long
term and mandibular advancement devices (MAD) have emerged as the leading alternative to
CPAP. So, MADs are now a reliable alternative to CPAP treatments, which position these in
numerous patients as a first therapy. Moreover, mild to moderate symptomatic patients who
refuse to be diagnosed are now referring to sleep centers in order to be treated. MAD and
CPAP are similarly effective on symptoms, quality of life and in attaining reductions in
blood pressure and cardiovascular morbidity. Although CPAP has a greater effect on Apnea +
hypopnea index (AHI) reduction, adherence is better with MAD explaining the comparable mean
disease alleviation achieved by the two treatment modalities.
Despite good tolerance and efficacy, there are still barriers limiting the widespread use of
MAD and its acceptance in OSA routine clinical practice. Various different MAD designs
currently exist and constantly emerge on the market without clear evidence regarding the best
technical choice and the cost-effectiveness compromise. Titratable two-piece custom-made MADs
are the gold standard in clinical guidelines and several brands are now on the market.
Although these MAD has been tested in term of efficacy, no study has tested the difference
between MADs in term of efficacy, tolerance and patient satisfaction. Such a paradigm merits
being tested in a randomized controlled trial. The SONAR study is a multicenter,
parallel-group randomized controlled trial to determine if the titratable MAD NARVAL TM is
superior to the titratable MAD TALITM in OSA patients eligible for MAD. The primary outcome
will be the treatment response at 3 months assessed by the difference of delta AHI at
baseline and follow-up measured by polysomnography and secondary outcomes focus at global
efficacy, tolerance and patient satisfaction.
To our knowledge it will be the first study comparing two titrable MADs.
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