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

This study is currently recruiting participants.
Verified February 2012 by University Hospital, Antwerp
Sponsor:
Information provided by (Responsible Party):
Ethisch Comité UZ Antwerpen, University Hospital, Antwerp
ClinicalTrials.gov Identifier:
NCT01532050
First received: January 30, 2012
Last updated: February 8, 2012
Last verified: February 2012

January 30, 2012
February 8, 2012
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Complete list of historical versions of study NCT01532050 on ClinicalTrials.gov Archive Site
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PROMAD: Predicting Therapeutic Outcome of Mandibular Advancement Device Treatment in Obstructive Sleep Apnea
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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Interventional
Phase 4
Intervention Model: Single Group Assignment
Obstructive Sleep Apnea Syndrome
Device: Mandibular Advancement Device ( MAD)
Mandibular Advancement Device (MAD)
Intervention: Device: Mandibular Advancement Device ( MAD)
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
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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
Both
18 Years and older
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Contact: Marc J Braem, DDS, PhD 0032 3 821 3389 marc.braem@ua.ac.be
Contact: Olivier M Vanderveken, MD, PhD 0032 3 821 3385 olivier.vanderveken@uza.be
Belgium
 
NCT01532050
IWT MRA UZA
No
Ethisch Comité UZ Antwerpen, University Hospital, Antwerp
Ethisch Comité UZ Antwerpen
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University Hospital, Antwerp
February 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP