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Validation of Functional Imaging as Predictive Tool for Outcome of Mandibular Replacement Appliance Therapy in Obstructive Sleep Apnea Hypopnea Syndrome Patients

This study is currently recruiting participants.
Verified February 2012 by University Hospital, Antwerp
Sponsor:
Information provided by (Responsible Party):
Wilfried De Backer, University Hospital, Antwerp
ClinicalTrials.gov Identifier:
NCT01524510
First received: January 23, 2012
Last updated: February 2, 2012
Last verified: February 2012
History of Changes
  Purpose

In this open prospective study 40 patients who received Mandibular Replacement Appliance (MRA) Therapy as treatment of Obstructive Sleep Apnea Hypopnea Syndrome (OSAHS) will be included. The patient's sleep will be registered during 2 periods of 2 days: one while the patient does not wear the MRA and, +/- 1 week later, one while the patient wears the MRA. Furthermore, 2 low dose CT scans (one with and one without the MRA device in the mouth) will be taken. These data must allow the investigators to validate the use of functional imaging (segmentation and Computational Fluid Dynamics) as a predictor of the outcome of the MRA therapy in OSAHS patients.


Condition Intervention Phase
Obstructive Sleep Apnea Syndrome
 Radiation: CT scan
Device: Alice PDx polygraphy
 Phase 4

Study Type: Interventional
Study Design: Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Diagnostic
Official Title: Open, Prospective Study for the Validation of the Predictive Value of Upper Airway Segmentation and CFD Analysis on Outcome Parameters of the Mandibular Replacement Appliance (MRA) Therapy in Obstructive Sleep Apnea Hypopnea Syndrome OSAHS) Patients

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by University Hospital, Antwerp:

Primary Outcome Measures:
  • changes in mean AHI between visit 1 and visit 2 [ Time Frame: visit 1 (AHI of 2 nights without MRA) / visit 2 (AHI of 2 nights with MRA) (visit 2 happens +/- 1 week after visit 1) ] [ Designated as safety issue: No ]
    evaluate the predictive value of upper airway segmentation and CFD analysis on responsiveness to MRA therapy in OSAHS patients

  • changes in UA resistance [ Time Frame: 1 CT scan without MRA (UA resistance without MRA) / 1 CT scan with MRA (UA resistance with MRA) ] [ Designated as safety issue: No ]
    evaluate the predictive value of upper airway segmentation and CFD analysis on responsiveness to MRA therapy in OSAHS patients


Secondary Outcome Measures:
  • changes in mean ESS between visit 1 and visit 2 [ Time Frame: visit 1 (ESS of 2 nights without MRA) / visit 2 (ESS of 2 nights with MRA) (visit 2 happens +/- 1 week after visit 1) ] [ Designated as safety issue: No ]
    to assess the effect of the MRA therapy on daytime sleepiness with the Epworth Sleepiness Scale (ESS).


Estimated Enrollment: 40
Study Start Date: February 2011
Estimated Primary Completion Date: April 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: MRA
All OSAS patients will be asked to sleep two nights without MRA and, +/- 1 week later, two nights with MRA
 Radiation: CT scan
low dose radiation scan without contrast without and with MRA
Device: Alice PDx polygraphy
Alice PDx polygraphy (Respironics)

  Eligibility

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

Inclusion Criteria:

  1. Patients with documented OSAHS based on the following criteria:

    AHI >= 5 Complaints of extreme daytime sleepiness with no other explanation and/or 2 or more of the following symptoms:

    • choking or gasping during sleep
    • recurrent awakenings from sleep
    • un-refreshing sleep
    • daytime fatigue
    • impaired concentration
  2. Patients who received MRA as treatment for OSAHS
  3. AHI >= 5 on at least 1 of the screening nights (patient does not wear MRA device)
  4. Male or female patients aged ≥ 18 years
  5. Patients with a co-operative attitude
  6. Written informed consent obtained

Exclusion Criteria:

  1. Pregnant or lactating females or females at risk of pregnancy
  2. Patients with an uncontrolled disease or any condition that might, in the judgement of the investigator, place the patient at undue risk or potentially compromise the results or interpretation of the study.
  3. Cancer or any other chronic disease with poor prognosis and/or affecting patient status
  4. History of alcohol or drug abuse in the last 2 years
  5. Patients unlikely to comply with the protocol or unable to understand the nature, scope and possible consequences of the study
  6. Patients who participate in another clinical study whose investigational plan is judged to interfere or affect any of the measures of this study
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01524510

Contacts
Contact: Wilfried De Backer, MD +32 3 821 3447 wilfried.de.backer@uza.be
Contact: Wim D'Hondt, MSc +32 3 821 5529 wim.dhondt@uza.be

Locations
Belgium
UZA Recruiting
Edegem, Antwerp, Belgium, 2650
Contact: Wilfried De Backer, MD     +32 3 821 34 47     wilfried.de.backer@uza.be    
Contact: Wim D'Hondt, MSc     +32 3 821 55 29     wim.dhondt@uza.be    
Principal Investigator: Wilfried De Backer, MD            
Sponsors and Collaborators
University Hospital, Antwerp
  More Information

No publications provided

Responsible Party: Wilfried De Backer, Prof. Dr., University Hospital, Antwerp
ClinicalTrials.gov Identifier: NCT01524510     History of Changes
Other Study ID Numbers: PML_DOC_1101
Study First Received: January 23, 2012
Last Updated: February 2, 2012
Health Authority: Belgium: Federal Agency for Medicinal Products and Health Products

Keywords provided by University Hospital, Antwerp:
OSAS
AHI
MRA
CFD

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 May 23, 2013