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

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.

Study Overview

• Status: Unknown
• Conditions: Obstructive Sleep Apnea Syndrome
• Intervention / Treatment: Radiation: CT scan; Device: Alice PDx polygraphy

• Study Type: Interventional
• Enrollment (Anticipated): 40
• Phase: Phase 4

Contacts and Locations

Study Locations

• Belgium
  • Antwerp
    • Edegem, Antwerp, Belgium, 2650
      • Recruiting
      • UZA
      • Contact: Annemie Hufkens, MSc; Phone Number: +32 3 821 41 42; Email: annemie.hufkens@uza.be
      • Contact: Wilfried De Backer, MD; Phone Number: +32 3 821 34 47; Email: wilfried.de.backer@uza.be
      • Principal Investigator: Wilfried De Backer, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

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

What is the study measuring?

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)

Collaborators and Investigators

• Sponsor: University Hospital, Antwerp

Study record dates

Study Major Dates

• Study Start: February 1, 2011
• Primary Completion (Anticipated): April 1, 2016

Study Registration Dates

• First Submitted: January 23, 2012
• First Submitted That Met QC Criteria: February 1, 2012
• First Posted (Estimate): February 2, 2012

Study Record Updates

• Last Update Posted (Estimate): May 28, 2015
• Last Update Submitted That Met QC Criteria: May 27, 2015
• Last Verified: May 1, 2015

More Information

Terms related to this study

• Keywords: MRA; AHI; OSAS; CFD
• Additional Relevant MeSH Terms: Pathologic Processes; Nervous System Diseases; Respiratory Tract Diseases; Respiration Disorders; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Disease; Signs and Symptoms, Respiratory; Sleep Apnea Syndromes; Sleep Apnea, Obstructive; Syndrome; Apnea
• Other Study ID Numbers: PML_DOC_1101