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

Obstructive Sleep Apnea Syndrome Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01524510
• Other study ID #: PML_DOC_1101
• Status: Recruiting
• Phase: Phase 4
• First received: January 23, 2012
• Last updated: May 27, 2015
• Start date: February 2011

Study information

• Verified date: May 2015
• Source: University Hospital, Antwerp
• Contact: Wilfried De Backer, MD
• Phone: +32 3 821 3447
• Email: wilfried.de.backer[@]uza.be
• Is FDA regulated: No
• Health authority: Belgium: Federal Agency for Medicinal Products and Health Products
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 40
• Est. primary completion date: April 2016
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Diagnostic

Related Conditions & MeSH terms

• Apnea
• Obstructive Sleep Apnea Syndrome
• Sleep Apnea Syndromes
• Sleep Apnea, Obstructive
• Syndrome

Intervention

Radiation:
• CT scan
low dose radiation scan without contrast without and with MRA

Device:
• Alice PDx polygraphy
Alice PDx polygraphy (Respironics)

Locations

Country	Name	City	State
Belgium	UZA	Edegem	Antwerp

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Antwerp

Country where clinical trial is conducted

Belgium, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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)	No
Primary	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)	No
Secondary	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)	No