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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| MRA | Experimental | All OSAS patients will be asked to sleep two nights without MRA and, +/- 1 week later, two nights with MRA |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| CT scan | Radiation | low dose radiation scan without contrast without and with MRA |
| |
| 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) |
| 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) |
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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:
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:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Wilfried De Backer, MD | Contact | +32 3 821 3447 | wilfried.de.backer@uza.be | |
| Annemie Hufkens, MSc | Contact | +32 3 821 41 42 | annemie.hufkens@uza.be |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| UZA | Recruiting | Edegem | Antwerp | 2650 | Belgium |
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| Alice PDx polygraphy |
| Device |
Alice PDx polygraphy (Respironics) |
|
| ID | Term |
|---|---|
| D020181 | Sleep Apnea, Obstructive |
| ID | Term |
|---|---|
| D012891 | Sleep Apnea Syndromes |
| D001049 | Apnea |
| D012120 | Respiration Disorders |
| D012140 | Respiratory Tract Diseases |
| D020919 | Sleep Disorders, Intrinsic |
| D020920 | Dyssomnias |
| D012893 | Sleep Wake Disorders |
| D009422 | Nervous System Diseases |
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