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Title
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Predicting therapeutic outcome of mandibular advancement device treatment in obstructive sleep apnoea (PROMAD) : study design and baseline characteristics
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Author
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Abstract
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| Study Objectives: Oral appliances have gained their place in the treatment of obstructive sleep apnea (OSA) where custom-made titratable mandibular advancement devices (OAm) have become the oral appliance of choice. Retrospective studies assessing possible predictors of treatment outcome with OAm have been published but are lacking uniformity in their conclusions. The PRedicting therapeutic Outcome of Mandibular Advancement Device treatment in OSA (PROMAD) study aims at identifying predictive screening methods for treatment success with OAm, assessing the following upper airway (UA) evaluation methods: awake nasendoscopy including Müller manoeuvre, and drug-induced sedation endoscopy (DISE) will identify the level, degree, and pattern of UA collapse; while computed tomography (CT)-scan based computational fluid dynamics (CFD) will evaluate changes in UA volume and resistance. Methods: PROMAD is a prospective, single-center cohort study that enrolled 100 consecutive patients with diagnosed OSA (5 events/h < apnea-hypopnea index (AHI) < 50 events/h) to be treated with a custom-made titratable OAm. Primary endpoints are the positive and negative predictive values of awake nasendoscopy including Müller manoeuvre, DISE, and CFD with and without the OAm, toward reduction in AHI. Univariate and multivariate analyses will be performed to determine which of the investigations and/or combinations thereof predict success. Conclusions: PROMAD is a prospective trial to investigate the predictive potential of awake nasendoscopy including Müller manoeuvre, DISE, and CFD, and any combination thereof in the prediction of reduction of AHI with OAm in OSA patients. The results will allow translating the assessments into optimal OSA patient selection, leading to evidence-based decision making and targeted OAm treatment. |
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Language
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English
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Source (journal)
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Journal of dental sleep medicine
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Publication
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2016
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DOI
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10.15331/JDSM.6250
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Volume/pages
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3
:4
(2016)
, p. 119-138
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Full text (Publisher's DOI)
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Full text (open access)
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