Obstructive Sleep Apnea SyndromePhase 4NCT01524510
Validation of Functional Imaging as Predictive Tool for Outcome of Mandibular Replacement Appliance Therapy in Obstructive Sleep Apnea Hypopnea Syndrome Patients
A Phase 4 study testing CT scan and Alice PDx polygraphy in people with Obstructive Sleep Apnea Syndrome, run by University Hospital, Antwerp at 1 site in Belgium.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Obstructive Sleep Apnea Syndrome
- What is being tested?
- CT scan and Alice PDx polygraphy
- Type of treatment
- Medical device, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteBelgium
- Study dates
- Feb 2011to Apr 2016
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Show all 12Show fewer
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Belgium1 site, 1 recruiting
- Recruiting
UZA
Edegem, Antwerp, 2650
Wilfried De Backer, MD, +32 3 821 34 47, wilfried.de.backer@uza.be
Annemie Hufkens, MSc, +32 3 821 41 42, annemie.hufkens@uza.be
About this study
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
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
- Being tested
- CT scan, Alice PDx polygraphy
- Keywords
- OSAS, AHI, MRA, CFD
- Medical subject headings
- Sleep Apnea, Obstructive
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CT scanRadiation
low dose radiation scan without contrast without and with MRA
Alice PDx polygraphyDevice
Alice PDx polygraphy (Respironics)
| Study group | Role | What they receive |
|---|---|---|
| MRA | Experimental | All OSAS patients will be asked to sleep two nights without MRA and, +/- 1 week later, two nights with MRA Receives: Radiation: CT scan; Device: Alice PDx polygraphy |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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
Measured: 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
to assess the effect of the MRA therapy on daytime sleepiness with the Epworth Sleepiness Scale (ESS).
Measured: visit 1 (ESS of 2 nights without MRA) / visit 2 (ESS of 2 nights with MRA) (visit 2 happens +/- 1 week after visit 1)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Feb 2012 (estimated)
- Study startFeb 2011
- Primary completionApr 2016 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Obstructive Sleep Apnea SyndromeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Antwerp
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Wilfried De Backer, University Hospital, Antwerp
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01524510
- Sponsor's protocol ID
- PML_DOC_1101
- Status last verified
- May 2015
- First submitted
- 23 Jan 2012
- Last updated
- 28 May 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 May 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT01524510
- Acronym / sponsor ID
- PML_DOC_1101
- Conditions
- Obstructive Sleep Apnea Syndrome
- Keywords
- OSAS, AHI, MRA, CFD
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- University Hospital, AntwerpUniversity, hospital or other
- Study start
- Feb 2011
- Primary completion
- Apr 2016 (estimated)
- First posted
- 2 Feb 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| MRA | Experimental | Radiation: CT scan, Device: Alice PDx polygraphyAll OSAS patients will be asked to sleep two nights without MRA and, +/- 1 week later, two nights with MRA |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (12 listed)
- 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:
- 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
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| CT scanlow dose radiation scan without contrast without and with MRA | Radiation | MRA |
| Alice PDx polygraphyAlice PDx polygraphy (Respironics) | Device | MRA |
Primary outcome
changes in mean AHI between visit 1 and visit 2
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)
evaluate the predictive value of upper airway segmentation and CFD analysis on responsiveness to MRA therapy in OSAHS patients
changes in UA resistance
Time frame: 1 CT scan without MRA (UA resistance without MRA) / 1 CT scan with MRA (UA resistance with MRA)
evaluate the predictive value of upper airway segmentation and CFD analysis on responsiveness to MRA therapy in OSAHS patients
1 secondary outcome
changes in mean ESS between visit 1 and visit 2
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)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 May 2015.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing CT scan and Alice PDx polygraphy in people with Obstructive Sleep Apnea Syndrome, run by University Hospital, Antwerp at 1 site in Belgium.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 12 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 28 May 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Belgium. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Wilfried De Backer, MD (+32 3 821 3447, wilfried.de.backer@uza.be), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
changes in mean AHI between visit 1 and visit 2 (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)). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 May 2015.