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

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Ethisch Comité UZ Antwerpen, University Hospital, Antwerp
ClinicalTrials.gov Identifier:
NCT01532050
First received: January 30, 2012
Last updated: April 1, 2014
Last verified: April 2014
  Purpose

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.


Condition Intervention Phase
Obstructive Sleep Apnea Syndrome
Device: Mandibular Advancement Device ( MAD)
Phase 4

Study Type: Interventional
Study Design: Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Double Blind (Subject, Caregiver)
Primary Purpose: Treatment
Official Title: PROMAD : Predicting Therapeutic Outcome of Mandibular Advancement Device Treatment in Obstructive Sleep Apnea

Resource links provided by NLM:


Further study details as provided by University Hospital, Antwerp:

Primary Outcome Measures:
  • Predictive value of DISE and CFD [ Time Frame: 3 months ] [ Designated as safety issue: No ]
    Positive and negative predictive values for AHI based treatment outcome


Estimated Enrollment: 100
Study Start Date: February 2012
Estimated Primary Completion Date: December 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Mandibular Advancement Device (MAD)
Mandibular Advancement Device (MAD)
Device: Mandibular Advancement Device ( MAD)

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01532050

Locations
Belgium
Antwerp University Hospital
Edegem, Antwerp, Belgium, 2650
Sponsors and Collaborators
Ethisch Comité UZ Antwerpen
  More Information

No publications provided

Responsible Party: Ethisch Comité UZ Antwerpen, prof. Marc Braem, DDS, PhD, University Hospital, Antwerp
ClinicalTrials.gov Identifier: NCT01532050     History of Changes
Other Study ID Numbers: IWT MRA UZA
Study First Received: January 30, 2012
Last Updated: April 1, 2014
Health Authority: Belgium: Ethics Committee

Keywords provided by University Hospital, Antwerp:
OSAS
American Academy of Sleep Medicine Task Force

Additional relevant MeSH terms:
Apnea
Sleep Apnea Syndromes
Sleep Apnea, Obstructive
Respiration Disorders
Respiratory Tract Diseases
Signs and Symptoms, Respiratory
Signs and Symptoms
Sleep Disorders, Intrinsic
Dyssomnias
Sleep Disorders
Nervous System Diseases

ClinicalTrials.gov processed this record on April 16, 2014