This trial is active, not recruiting.

Condition obstructive sleep apnea syndrome
Treatment mandibular advancement device ( mad)
Phase phase 4
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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Endpoint classification efficacy study
Intervention model single group assignment
Masking double blind (subject, caregiver)
Primary purpose treatment
Mandibular Advancement Device (MAD)
mandibular advancement device ( mad)

Primary Outcomes

Predictive value of DISE and CFD
time frame: 3 months

Eligibility Criteria

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

Additional Information

Official title PROMAD : Predicting Therapeutic Outcome of Mandibular Advancement Device Treatment in Obstructive Sleep Apnea
Trial information was received from ClinicalTrials.gov and was last updated in April 2014.
Information provided to ClinicalTrials.gov by University Hospital, Antwerp.