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

Primary Purpose

Obstructive Sleep Apnea Syndrome

Status
Unknown status
Phase
Phase 4
Locations
Belgium
Study Type
Interventional
Intervention
CT scan
Alice PDx polygraphy
Sponsored by
University Hospital, Antwerp
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Obstructive Sleep Apnea Syndrome focused on measuring OSAS, AHI, MRA, CFD

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • UZARecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

MRA

Arm Description

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

Outcomes

Primary Outcome Measures

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
changes in UA resistance
evaluate the predictive value of upper airway segmentation and CFD analysis on responsiveness to MRA therapy in OSAHS patients

Secondary Outcome Measures

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).

Full Information

First Posted
January 23, 2012
Last Updated
May 27, 2015
Sponsor
University Hospital, Antwerp
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1. Study Identification

Unique Protocol Identification Number
NCT01524510
Brief Title
Validation of Functional Imaging as Predictive Tool for Outcome of Mandibular Replacement Appliance Therapy in Obstructive Sleep Apnea Hypopnea Syndrome Patients
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
Study Type
Interventional

2. Study Status

Record Verification Date
May 2015
Overall Recruitment Status
Unknown status
Study Start Date
February 2011 (undefined)
Primary Completion Date
April 2016 (Anticipated)
Study Completion Date
undefined (undefined)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University Hospital, Antwerp

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Obstructive Sleep Apnea Syndrome
Keywords
OSAS, AHI, MRA, CFD

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Phase 4
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
40 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
MRA
Arm Type
Experimental
Arm Description
All OSAS patients will be asked to sleep two nights without MRA and, +/- 1 week later, two nights with MRA
Intervention Type
Radiation
Intervention Name(s)
CT scan
Intervention Description
low dose radiation scan without contrast without and with MRA
Intervention Type
Device
Intervention Name(s)
Alice PDx polygraphy
Intervention Description
Alice PDx polygraphy (Respironics)
Primary Outcome Measure Information:
Title
changes in mean AHI between visit 1 and visit 2
Description
evaluate the predictive value of upper airway segmentation and CFD analysis on responsiveness to MRA therapy in OSAHS patients
Time Frame
visit 1 (AHI of 2 nights without MRA) / visit 2 (AHI of 2 nights with MRA) (visit 2 happens +/- 1 week after visit 1)
Title
changes in UA resistance
Description
evaluate the predictive value of upper airway segmentation and CFD analysis on responsiveness to MRA therapy in OSAHS patients
Time Frame
1 CT scan without MRA (UA resistance without MRA) / 1 CT scan with MRA (UA resistance with MRA)
Secondary Outcome Measure Information:
Title
changes in mean ESS between visit 1 and visit 2
Description
to assess the effect of the MRA therapy on daytime sleepiness with the Epworth Sleepiness Scale (ESS).
Time Frame
visit 1 (ESS of 2 nights without MRA) / visit 2 (ESS of 2 nights with MRA) (visit 2 happens +/- 1 week after visit 1)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Wilfried De Backer, MD
Phone
+32 3 821 3447
Email
wilfried.de.backer@uza.be
First Name & Middle Initial & Last Name or Official Title & Degree
Annemie Hufkens, MSc
Phone
+32 3 821 41 42
Email
annemie.hufkens@uza.be
Facility Information:
Facility Name
UZA
City
Edegem
State/Province
Antwerp
ZIP/Postal Code
2650
Country
Belgium
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Wilfried De Backer, MD
Phone
+32 3 821 34 47
Email
wilfried.de.backer@uza.be
First Name & Middle Initial & Last Name & Degree
Annemie Hufkens, MSc
Phone
+32 3 821 41 42
Email
annemie.hufkens@uza.be
First Name & Middle Initial & Last Name & Degree
Wilfried De Backer, MD

12. IPD Sharing Statement

Learn more about this trial

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

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