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

Study Overview
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Brief Summary
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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.

Official Title
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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

Conditions
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Obstructive Sleep Apnea Syndrome

Intervention / Treatment
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* Radiation: CT scan
* Device: Alice PDx polygraphy


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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 Patients who received MRA as treatment for OSAHS AHI >= 5 on at least 1 of the screening nights (patient does not wear MRA device) Male or female patients aged ≥ 18 years Patients with a co-operative attitude Written informed consent obtained Exclusion Criteria: Pregnant or lactating females or females at risk of pregnancy 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. Cancer or any other chronic disease with poor prognosis and/or affecting patient status History of alcohol or drug abuse in the last 2 years Patients unlikely to comply with the protocol or unable to understand the nature, scope and possible consequences of the study Patients who participate in another clinical study whose investigational plan is judged to interfere or affect any of the measures of this study

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: MRA<br>All OSAS patients will be asked to sleep two nights without MRA and, +/- 1 week later, two nights with MRA | Radiation: CT scan<br>* low dose radiation scan without contrast without and with MRA<br>Device: Alice PDx polygraphy<br>* Alice PDx polygraphy (Respironics)<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| changes in mean AHI between visit 1 and visit 2 | evaluate the predictive value of upper airway segmentation and CFD analysis on responsiveness to MRA therapy in OSAHS patients | visit 1 (AHI of 2 nights without MRA) / visit 2 (AHI of 2 nights with MRA) (visit 2 happens +/- 1 week after visit 1) | 
| changes in UA resistance | evaluate the predictive value of upper airway segmentation and CFD analysis on responsiveness to MRA therapy in OSAHS patients | 1 CT scan without MRA (UA resistance without MRA) / 1 CT scan with MRA (UA resistance with MRA) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| changes in mean ESS between visit 1 and visit 2 | to assess the effect of the MRA therapy on daytime sleepiness with the Epworth Sleepiness Scale (ESS). | visit 1 (ESS of 2 nights without MRA) / visit 2 (ESS of 2 nights with MRA) (visit 2 happens +/- 1 week after visit 1) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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OSAS, AHI, MRA, CFD