PROMAD: Predicting Therapeutic Outcome of Mandibular Advancement Device Treatment in Obstructive Sleep Apnea

ethisch.comite@uza.be

Status and phase

Completed

Phase 4

Conditions

Obstructive Sleep Apnea Syndrome

Treatments

Device: Mandibular Advancement Device ( MAD)

Study type

Interventional

Funder types

Other

Identifiers

NCT01532050

IWT MRA UZA

Details and patient eligibility

About

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.

Enrollment

100 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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