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

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.

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Key information

Conditions

Obstructive Sleep Apnea Syndrome Apnea Dyssomnias Nervous System Diseases Respiration Disorders Respiratory Tract Diseases Sleep Apnea Syndromes Sleep Apnea, Obstructive Sleep Disorders, Intrinsic Sleep Wake Disorders

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Antwerp University Hospital

Edegem, Antwerp, 2650, Belgium

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Mandibular Advancement Device ( MAD)

Device

Primary outcomes

Predictive value of DISE and CFD

Time frame: 3 months

Positive and negative predictive values for AHI based treatment outcome

Sponsors and collaborators

Lead sponsor

[email protected]

Other

Registry information

Official study title

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

Acronym: PROMAD

Important dates

Study start: 2012
Primary completion: 2015
Study completion: 2015
First posted: Feb 13, 2012
Registry last updated: Jan 20, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed