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

NCT ID: NCT01524510

Last Updated: 2015-05-28

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE4
• Total Enrollment: 40 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2011-02-28

Brief 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

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: DIAGNOSTIC
• Blinding Strategy: NONE

Study Groups

MRA

All OSAS patients will be asked to sleep two nights without MRA and, +/- 1 week later, two nights with MRA

Group Type: EXPERIMENTAL

CT scan

Intervention Type: RADIATION

low dose radiation scan without contrast without and with MRA

Alice PDx polygraphy

Intervention Type: DEVICE

Alice PDx polygraphy (Respironics)

Interventions

CT scan

low dose radiation scan without contrast without and with MRA

Intervention Type: RADIATION

Alice PDx polygraphy

Alice PDx polygraphy (Respironics)

Intervention Type: DEVICE

Eligibility 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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University Hospital, Antwerp

OTHER

Sponsor Role: lead

Responsible Party

Wilfried De Backer

Prof. Dr.

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

UZA

Edegem, Antwerp, Belgium

Site Status: RECRUITING

Countries

Belgium

Central Contacts

Wilfried De Backer, MD

Role: CONTACT

wilfried.de.backer@uza.be

+32 3 821 3447

Annemie Hufkens, MSc

Role: CONTACT

annemie.hufkens@uza.be

+32 3 821 41 42

Facility Contacts

Wilfried De Backer, MD

Role: primary

wilfried.de.backer@uza.be

+32 3 821 34 47

Annemie Hufkens, MSc

Role: backup

annemie.hufkens@uza.be

+32 3 821 41 42

Other Identifiers

PML_DOC_1101

Identifier Type: -

Identifier Source: org_study_id