Efficacy and tolerability of a custom-made Narval mandibular repositioning device for the treatment of obstructive sleep apnea: ORCADES study 2-year follow-up data

Goutorbe, F.; Lavergne, Florent; Morin, Laurent; Abedipour, Darius; Allard-Redon, Aurélie; Aranda, Alexandre; Attali, Valérie; Bavozet, Frédérique; Becu, Martine; Beruben, Wally; Bessard, J.; Bonafe, Isabelle; Boukhana, Mohammed; Chabrol, Bruno; Chatté, G.; Chauvel‐Lebret, Dominique; Collet, Jean-Marc; Coste, Olivier; Dumont, Nathalie; Durand-Amat, Sophie; d’Ortho, Marie-Pia; Elbaum, J.-M.; Santerre, O. Gallet de; Goutorbes, Frédéric; Grandjean, Thierry; Guyot, Wilma; Hammer, Doniphan; Havasi, Carmen; Huet, Pascal; Kerbrat, Jean-Baptiste; Khemliche, Hauria; Koltes, Christian; Léger, Damien; Lacassagne, L.; Laur, Xavier; Lerousseau, Lionel; Liard, Olivier; Loisel, Christophe; Longuet, Matthieu; Mallart, A.; Martín, F García; Merle-Beral, Frédéric; Meurice, J.-C.; Mokhtari, Zoubida; Monaca, Christelle; Monteyrol, Pierre-Jean; Muir, Jean-François; Mullens, Eric; Muller, Dominique; Paoli, Charles; Petit, François-Xavier; Pigearias, B.; Pradines, Marc; Prigent, Arnauld; Putterman, Gil; Rey, Marc; Samama, Mickael; Tamisier, Renaud; Tiberge, M.; Tison, Cyrille; Tordjman, Fabienne; Triolet, Bernard; Vacher, P; Verain, A

doi:10.1016/j.sleep.2019.04.021

Cited by 12 publications

(6 citation statements)

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“…Long-term oral appliance use can cause tooth movement, change in bite, and temporomandibular joint (TMJ) discomfort. However, several recent studies have shown that oral appliance therapy was associated with no significant tooth movement over a period of several years [29]. These side effects are rare and manageable with the proper selection of an oral appliance and patient follow-up [30].…”

Section: Discussionmentioning

confidence: 99%

Efficacy and Effectiveness of the ProSomnus® [IA] Sleep Device for the Treatment of Obstructive Sleep Apnea: EFFECTS Study

Stern¹,

Lee²,

Kuhns³

et al. 2021

Cureus

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To evaluate the effectiveness of a new mandibular advancement device (MAD) (Prosomnus® [IA] Sleep Device, Prosomnus Sleep Technologies, Pleasanton CA) fitted with a compliance tracker as a first-line treatment in a population of patients with mild to severe obstructive sleep apnea (OSA). MethodsTreatment effectiveness was measured using pre and post-treatment home sleep testing (HST) and validated sleep and quality of life questionnaires. Mean disease alleviation (MDA) was calculated to compare the treatment effectiveness of MAD to historical continuous positive airway pressure (CPAP) effectiveness data. ResultsMAD was found to be an effective first-line treatment for patients with mild, moderate, and severe sleep apnea with excellent compliance rates, similar to or better than CPAP, and an equal or better MDA of 56.7% compared to literature values of 50% for CPAP. ConclusionsMAD should be considered an effective first-line treatment for patients with mild and moderate sleep apnea and for severe sleep apnea for patients who prefer, refuse, or are not candidates for CPAP.

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Section: Discussionmentioning

confidence: 99%

Efficacy and Effectiveness of the ProSomnus® [IA] Sleep Device for the Treatment of Obstructive Sleep Apnea: EFFECTS Study

Stern¹,

Lee²,

Kuhns³

et al. 2021

Cureus

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show abstract

“…Obstructive Sleep Apnea Syndrome (OSAS) is a breathing disorder that occurs during sleep, which is relatively common and easily overlooked [1] . At present, it is believed that OSAS may cause irreversible damage to the function of multiple systems of the whole body and significantly impact the cardiac function of patients.…”

Section: Introductionmentioning

confidence: 99%

Analysis of vasoactive and oxidative stress indicators for evaluating the efficacy of continuous positive airway pressure, and relation of vasoactive and oxidative stress indicators and cardiac function in obstructive sleep Apnea Syndrome patients

Wang

Tian

et al. 2024

J Med Biochemistry

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Objective: The work was to analyze vasoactive and oxidative stress indicators for evaluating the efficacy of Continuous positive airway pressure (CPAP), and evaluate the relation of vasoactive and oxidative stress indicators and cardiac function in Obstructive Sleep Apnea Syndrome (OSAS) patients. Methods: OSAS patients (n = 120) from May 2021 to June 2022 were treated with CPAP. According to the clinical efficacy, the patients were divided into effective group and ineffective group. Vasoactive factors and oxidative stress indices were compared between the two groups to evaluate their clinical efficacy. The changes of cardiac function indices in the two groups were tested, and the correlation between vasoactive factors and oxidative stress indices and cardiac function was analyzed. Results: The effective rate of CPAP was 63.33% (76/120). Levels of Ang II, ET-1 and MDA were lower and SOD level was higher in the effective group than the ineffective group after treatment. AUC of the four indicators was all greater than 0.75. LPWT and IVST values of the effective group were lower than the ineffective group. A positive correlation was identified between the levels of AngⅡ, ET-1, and MDA with LPWT, between levels of ET-1 and MDA with IVST, and a negative correlation between SOD with LPWT and IVST. Conclusion: CPAP treatment can effectively improve the vascular activity and reduce the oxidative stress response of OSAS patients, and the combined detection of vasoactive factors and oxidative stress indicators is valuable for evaluating the efficacy of CPAP, and is related to cardiac function.

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“…This CPAP therapy is also the gold standard in AHI reduction, as it improves the patient's quality of life, reduces the risk of motor vehicle accidents, and reduces cardiovascular events and mortality associated with OSA. However, between 30% and 50% of patients prescribed CPAP fail to maintain long-term adherence [8,9].…”

Section: Introductionmentioning

confidence: 99%

Computed Tomography versus Sleep Endoscopy (DISE) to Predict the Effectiveness of Mandibular Advancement Devices in Adult Patients with Obstructive Sleep Apnea: A Protocol for Systematic Review

Cebola,

Caroça,

Donato

et al. 2023

JCM

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Obstructive sleep apnea is a sleep disorder with a high prevalence in the world population. The mandibular advancement device is one of the options for treating obstructive sleep apnea. Neck computed tomography and drug-induced sleep endoscopy are complementary diagnostic tests that may help predict the effectiveness of mandibular advancement devices. This study aims to analyze the best method for predicting the effectiveness of mandibular advancement devices in the therapeutic approach to obstructive sleep apnea. PubMed, Embase, Cochrane Central Register of Controlled Trials (CENTRAL), and Web of Science Core Collection databases will be comprehensively searched. We will include randomized clinical trials, non-randomized prospective or retrospective clinical studies, case controls, cohort studies, and case series. Two authors will independently conduct data extraction and assess the literature quality of the studies. The analysis of the included literature will be conducted by Revman 5.3 software. The outcomes that will be analyzed are craniofacial characteristics, cephalometric assessments, site and type of obstruction of the upper airway, mean values of the apnea–hypopnea index, and SaO2 verified in the initial and follow-up polysomnography. This study will provide reliable, evidence-based support for the clinical application of mandibular advancement devices for obstructive sleep apnea.

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Efficacy and tolerability of a custom-made Narval mandibular repositioning device for the treatment of obstructive sleep apnea: ORCADES study 2-year follow-up data

Cited by 12 publications

References 50 publications

Efficacy and Effectiveness of the ProSomnus® [IA] Sleep Device for the Treatment of Obstructive Sleep Apnea: EFFECTS Study

Efficacy and Effectiveness of the ProSomnus® [IA] Sleep Device for the Treatment of Obstructive Sleep Apnea: EFFECTS Study

Analysis of vasoactive and oxidative stress indicators for evaluating the efficacy of continuous positive airway pressure, and relation of vasoactive and oxidative stress indicators and cardiac function in obstructive sleep Apnea Syndrome patients

Computed Tomography versus Sleep Endoscopy (DISE) to Predict the Effectiveness of Mandibular Advancement Devices in Adult Patients with Obstructive Sleep Apnea: A Protocol for Systematic Review

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