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

Phase 4

Completed

• Conditions: Obstructive Sleep Apnea Syndrome
• Interventions: Device: Mandibular Advancement Device ( MAD)

• Registration Number: NCT01532050
• Lead Sponsor: ethisch.comite@uza.be

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2012-01-30
• Study Start: 2012-02
• Study First Submitted QC: 2012-02-08
• Study First Posted: 2012-02-13
• Primary Completion: 2015-07
• Study Completion: 2015-11
• Status Verified: 2021-01
• Last Update Submitted: 2021-01-15
• Last Update Posted: 2021-01-20

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 100

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Mandibular Advancement Device (MAD)	Mandibular Advancement Device ( MAD)	Mandibular Advancement Device (MAD)

Primary Outcome Measures

Name	Time	Method
Predictive value of DISE and CFD	3 months	Positive and negative predictive values for AHI based treatment outcome

Trial Locations

Locations (1)

Antwerp University Hospital; 🇧🇪 Edegem, Antwerp, Belgium