NCT01524510

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.

Trial Health

55
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
40

participants targeted

Target at P25-P50 for phase_4

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2011

Completed
12 months until next milestone

First Submitted

Initial submission to the registry

January 23, 2012

Completed
10 days until next milestone

First Posted

Study publicly available on registry

February 2, 2012

Completed
4.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2016

Completed
Last Updated

May 28, 2015

Status Verified

May 1, 2015

Enrollment Period

5.2 years

First QC Date

January 23, 2012

Last Update Submit

May 27, 2015

Conditions

Obstructive Sleep Apnea Syndrome

Keywords

OSASAHIMRACFD

Outcome Measures

Primary Outcomes (2)

  • 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 Outcomes (1)

  • changes in mean ESS between visit 1 and visit 2

    visit 1 (ESS of 2 nights without MRA) / visit 2 (ESS of 2 nights with MRA) (visit 2 happens +/- 1 week after visit 1)

Study Arms (1)

MRA

EXPERIMENTAL

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

Radiation: CT scanDevice: Alice PDx polygraphy

Interventions

CT scanRADIATION

low dose radiation scan without contrast without and with MRA

MRA
Alice PDx polygraphyDEVICE

Alice PDx polygraphy (Respironics)

MRA

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

UZA

Edegem, Antwerp, 2650, Belgium

RECRUITING

MeSH Terms

Conditions

Sleep Apnea, Obstructive

Condition Hierarchy (Ancestors)

Sleep Apnea SyndromesApneaRespiration DisordersRespiratory Tract DiseasesSleep Disorders, IntrinsicDyssomniasSleep Wake DisordersNervous System Diseases

Central Study Contacts

Wilfried De Backer, MD

CONTACT

+32 3 821 3447wilfried.de.backer@uza.be

Annemie Hufkens, MSc

CONTACT

+32 3 821 41 42annemie.hufkens@uza.be

Study Design

Study Type
interventional
Phase
phase 4
Allocation
NA
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Prof. Dr.

Study Record Dates

First Submitted

January 23, 2012

First Posted

February 2, 2012

Study Start

February 1, 2011

Primary Completion

April 1, 2016

Last Updated

May 28, 2015

Record last verified: 2015-05

Locations

BE(1)