NCT01524510

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

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

• Status: Unknown
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 40 (estimated)
• Sponsor: University Hospital, Antwerp · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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

Type	Name	Description
RADIATION	CT scan	low dose radiation scan without contrast without and with MRA
DEVICE	Alice PDx polygraphy	Alice PDx polygraphy (Respironics)

Timeline

• Start date: 2011-02-01
• Primary completion: 2016-04-01
• First posted: 2012-02-02
• Last updated: 2015-05-28

Locations

1 site across 1 country: Belgium