Clinical trial NCT01532050: PROMAD: Predicting Therapeutic Outcome of Mandibular Advancement Device Treatment in Obstructive Sleep Apnea
Official title: PROMAD : Predicting Therapeutic Outcome of Mandibular Advancement Device Treatment in Obstructive Sleep Apnea
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Obstructive Sleep Apnea Syndrome
Keywords: OSAS
American Academy of Sleep Medicine Task Force
Lead sponsor: University Hospital, Antwerp
Sponsor class: OTHER
First posted: 2012-02-13
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: 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.


Eligibility criteria: 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

Primary outcomes:
measure: Predictive value of DISE and CFD
timeFrame: 3 months
Secondary outcomes:
Other outcomes:
Locations:
city: Edegem
country: Belgium
facility: Antwerp University Hospital
state: Antwerp
Study officials:
References:
citation: Van Gaver H, Op de Beeck S, Dieltjens M, De Backer J, Verbraecken J, De Backer WA, Van de Heyning PH, Braem MJ, Vanderveken OM. Functional imaging improves patient selection for mandibular advancement device treatment outcome in sleep-disordered breathing: a prospective study. J Clin Sleep Med. 2022 Mar 1;18(3):739-750. doi: 10.5664/jcsm.9694.
citation: Op de Beeck S, Dieltjens M, Azarbarzin A, Willemen M, Verbraecken J, Braem MJ, Wellman A, Sands SA, Vanderveken OM. Mandibular Advancement Device Treatment Efficacy Is Associated with Polysomnographic Endotypes. Ann Am Thorac Soc. 2021 Mar;18(3):511-518. doi: 10.1513/AnnalsATS.202003-220OC.
citation: Van de Perck E, Op de Beeck S, Dieltjens M, Vroegop AV, Verbruggen AE, Willemen M, Verbraecken J, Van de Heyning PH, Braem MJ, Vanderveken OM. The relationship between specific nasopharyngoscopic features and treatment deterioration with mandibular advancement devices: a prospective study. J Clin Sleep Med. 2020 Jul 15;16(7):1189-1198. doi: 10.5664/jcsm.8474.
citation: Op de Beeck S, Dieltjens M, Verbruggen AE, Vroegop AV, Wouters K, Hamans E, Willemen M, Verbraecken J, De Backer WA, Van de Heyning PH, Braem MJ, Vanderveken OM. Phenotypic Labelling Using Drug-Induced Sleep Endoscopy Improves Patient Selection for Mandibular Advancement Device Outcome: A Prospective Study. J Clin Sleep Med. 2019 Aug 15;15(8):1089-1099. doi: 10.5664/jcsm.7796.
citation: Dieltjens M, Verbruggen AE, Braem MJ, Wouters K, Verbraecken JA, De Backer WA, Hamans E, Van de Heyning PH, Vanderveken OM. Determinants of Objective Compliance During Oral Appliance Therapy in Patients With Sleep-Disordered Breathing: A Prospective Clinical Trial. JAMA Otolaryngol Head Neck Surg. 2015 Oct;141(10):894-900. doi: 10.1001/jamaoto.2015.1756.