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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

NCT01524510 · Status: UNKNOWN · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 40

Last updated 2015-05-28

No results posted yet for this study

Summary

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.

Conditions

  • Obstructive Sleep Apnea Syndrome

Interventions

RADIATION

CT scan

low dose radiation scan without contrast without and with MRA

DEVICE

Alice PDx polygraphy

Alice PDx polygraphy (Respironics)

Sponsors & Collaborators

  • University Hospital, Antwerp

    lead OTHER

Study Design

Allocation
NA
Purpose
DIAGNOSTIC
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2011-02-28
Primary Completion
2016-04-30

Countries

  • Belgium

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01524510 on ClinicalTrials.gov