PROMAD: Predicting Therapeutic Outcome of Mandibular Advancement Device Treatment in Obstructive Sleep Apnea
This trial is active, not recruiting.
|Condition||obstructive sleep apnea syndrome|
|Treatment||mandibular advancement device ( mad)|
|Sponsor||Ethisch Comité UZ Antwerpen|
|Start date||February 2012|
|End date||December 2014|
|Trial size||100 participants|
|Trial identifier||NCT01532050, IWT MRA UZA|
The present research intends to focus clinically on selecting the right type of patient for mandibular advancement devices (MAD) therapy using screening tools such as advanced imaging and computational methods based on CT-Scan images as well as drug-induced sleep nasendoscopy techniques with simulation of the mandibular repositioning. The core of the research project relies on known and established methods accepted in several neighboring fields, but aims at the transfer of this knowledge by integrating it into this new domain. Doing so, the proposed biomedical research is directed towards clinical applications that incorporate innovative developments on the level of the diagnosis and therapy of a specific disease, being obstructive sleep apnea syndrome (OSAS). Furthermore, this study aims at registering objective compliance during MAD therapy.
|Endpoint classification||efficacy study|
|Intervention model||single group assignment|
|Masking||double blind (subject, caregiver)|
Mandibular Advancement Device (MAD)
Predictive value of DISE and CFD
time frame: 3 months
Male or female participants at least 18 years old.
Inclusion Criteria: - Age ≥ 18 years - body mass index (BMI) ≤ 35 kg/m² - OSAS, as defined by the American Academy of Sleep Medicine Task Force - apnea-hypopnea index (AHI) < 50 Exclusion Criteria: - Other sleep disorders (i.e. parasomnias) - Invasive upper airway surgery for sleep-disordered breathing - Known genetic disorders with craniofacial and/or upper airway malformations - Use of benzodiazepine and/or antidepressants - Known history of psychiatric disease - Known history of fibromyalgia and/or chronic fatigue syndrome - Dental contra-indications: functional restrictions of the temporomandibular joint, insufficient dentition with pathological changes, insufficient retention for MAD use
|Official title||PROMAD : Predicting Therapeutic Outcome of Mandibular Advancement Device Treatment in Obstructive Sleep Apnea|
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