Obstructive Sleep ApneaMMA-OSASNCT02762175
3D Volumetric Changes in the Upper Airway After MMA in OSAS Patients and the Implication on QOL: A Prospective Registry
An observational study of Obstructive Sleep Apnea, run by AZ Sint-Jan AV at 1 site in Belgium.
Trial summary
Background Obstructive sleep apnea syndrome (OSAS) is a sleep-related breathing disorder characterized by intense snoring and repetitive complete or partial obstructions of the upper airway during sleep together with daytime sleepiness. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Obstructive Sleep Apnea
- How many people
- 150 participants
- Where
- 1 siteBelgium
- Study dates
- Jan 2015to Jun 2030
- How long will I take part?
- 6 Months
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: all OSAS patients (AHI ≥ 5) requiring a MMA by Dr. Neyt starting from January 2015
Who may be able to join
- Patients of all ages
- Patients of all genders
- Patients diagnosed with OSAS, based on an AHI ≥ 5
- All consecutive OSAS patients operated by N. Neyt from January 2015 onwards
Who cannot join
- Patients not eligible according to abovementioned criteria
- Patients with morbid obesity (BMI >35), if judged non-eligible by the treating surgeon
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Araceli Diez-Fraile, MSc, PhD, VMD contact
Belgium1 site, 1 recruiting
- Recruiting
Division of Maxillofacial Surgery, Department of Surgery, AZ Sint-Jan Brugge Oostende AV
Bruges
Araceli Diez-Fraile, MSc, PhD, VMD
About this study
Official title: 3D Volumetric Changes in the Upper Airway After Maxillomandibular Advancement in Obstructive Sleep Apnea Syndrome Patients and the Implication on Quality of Life: A Prospective Registry
Background
Obstructive sleep apnea syndrome (OSAS) is a sleep-related breathing disorder characterized by intense snoring and repetitive complete or partial obstructions of the upper airway during sleep together with daytime sleepiness. Several non-invasive therapeutical options exist, however, they do not offer a permanent improvement. Maxillomandibular advancement (MMA) surgery is a procedure which changes the upper airway in a permanent way.
Read more
Objectives
The investigators aim to develop a prospective database registering 3D volumetric changes of the upper airway and its anatomic subregions, the apnea-hypopnea index (AHI) and quality of life (QOL) of all consecutive patients eligible for MMA, performed by Dr. Neyt. Patient demographics, detailed virtual cone-beam computed tomography (CBCT) planning parameters, orthognathic surgery, polysomnographic and QOL data are being collected during consecutive visits within the framework of routine practice.
Design
A prospective, observational cohort study
Study center
General Hospital (AZ) Sint-Jan Brugge-Oostende
Population
The investigators would like to include all OSAS patients (AHI ≥ 5) requiring a MMA by Dr. Neyt starting from January 2015.
Endpoints
The investigators aim to collect data that could provide information about the advantages and disadvantages of the routinely performed 3D CBCT preoperative MMA surgery planning for OSAS patients, regarding 3D volumetric changes of the upper airway and its anatomic subregions and quality of life (QOL) in a subjective manner with the Epworth Sleepiness Scale (ESS) and the OSAS questionnaire and in an objective manner with evaluation of the apnea-hypopnea index (AHI).
Duration
In light of the continuous improvement of patient care, a database will be maintained from January 2015 onwards to enable registration of large-scale OSAS patient data.
Conclusions
Development of a database registering 3D CBCT planning, polysomnographic data and quality of life (QOL) of all consecutive patients eligible for MMA, will provide more information about potential patient, virtual planning and surgical factors influencing accuracy of MMA, and the associated biological benefits of this procedure on the upper airway volume, the AHI and general QOL. Moreover, registration of those results could function as a measurement of quality of care, or could be used for sample size calculation for future large multicenter prospective trials.
- Conditions
- Obstructive Sleep Apnea
- Keywords
- maxillomandibular advancement, obstructive sleep apnea, apnea-hypopnea index, quality of life
- Medical subject headings
- Sleep Apnea, Obstructive
What is being measured
The primary outcome is the main question the study is designed to answer.
postoperative apnea-hypopnea index, measured with polysomnography
Measured: 6-12 months
Secondary outcomes (3)
3D volumetric changes of the upper airway, measured with cone-beam CT
Measured: 4-6 months
quality of life, measured with epworth sleepiness scale
Measured: 4-12 months
quality of life, measured with OSAS questionnaire
Measured: 4-12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 May 2016 (estimated)
- Study startJan 2015
- Primary completionJan 2030 (estimated)
- Study completionJun 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Obstructive Sleep ApneaStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 150 participants (estimated)
- Target duration
- 6 Months
Sponsor and investigators
- Lead sponsor
- AZ Sint-Jan AV
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Nathalie Neyt, AZ Sint-Jan AV
- Investigators
- Nathalie Neyt, MD, Principal investigator, Division of Maxillofacial Surgery, Department of Surgery, AZ Sint-Jan Brugge-Oostende AV
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02762175
- Sponsor's protocol ID
- B049201627590
- Acronym
- MMA-OSAS
- Status last verified
- Feb 2022
- First submitted
- 3 May 2016
- Last updated
- 28 Feb 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Feb 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 3D Volumetric Changes in the Upper Airway After Maxillomandibular Advancement in Obstructive Sleep Apnea Syndrome Patients and the Implication on Quality of Life: A Prospective Registry
- ClinicalTrials.gov ID
- NCT02762175
- Acronym / sponsor ID
- MMA-OSAS / B049201627590
- Conditions
- Obstructive Sleep Apnea
- Keywords
- maxillomandibular advancement, obstructive sleep apnea, apnea-hypopnea index, quality of life
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- AZ Sint-Jan AVUniversity, hospital or other
- Study start
- Jan 2015
- Primary completion
- Jan 2030 (estimated)
- Study completion
- Jun 2030 (estimated)
- First posted
- 4 May 2016 (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.
Background
Obstructive sleep apnea syndrome (OSAS) is a sleep-related breathing disorder characterized by intense snoring and repetitive complete or partial obstructions of the upper airway during sleep together with daytime sleepiness. Several non-invasive therapeutical options exist, however, they do not offer a permanent improvement. Maxillomandibular advancement (MMA) surgery is a procedure which changes the upper airway in a permanent way.
Objectives
The investigators aim to develop a prospective database registering 3D volumetric changes of the upper airway and its anatomic subregions, the apnea-hypopnea index (AHI) and quality of life (QOL) of all consecutive patients eligible for MMA, performed by Dr. Neyt. Patient demographics, detailed virtual cone-beam computed tomography (CBCT) planning parameters, orthognathic surgery, polysomnographic and QOL data are being collected during consecutive visits within the framework of routine practice.
Design
A prospective, observational cohort study
Study center
General Hospital (AZ) Sint-Jan Brugge-Oostende
Population
The investigators would like to include all OSAS patients (AHI ≥ 5) requiring a MMA by Dr. Neyt starting from January 2015.
Endpoints
The investigators aim to collect data that could provide information about the advantages and disadvantages of the routinely performed 3D CBCT preoperative MMA surgery planning for OSAS patients, regarding 3D volumetric changes of the upper airway and its anatomic subregions and quality of life (QOL) in a subjective manner with the Epworth Sleepiness Scale (ESS) and the OSAS questionnaire and in an objective manner with evaluation of the apnea-hypopnea index (AHI).
Duration
In light of the continuous improvement of patient care, a database will be maintained from January 2015 onwards to enable registration of large-scale OSAS patient data.
Conclusions
Development of a database registering 3D CBCT planning, polysomnographic data and quality of life (QOL) of all consecutive patients eligible for MMA, will provide more information about potential patient, virtual planning and surgical factors influencing accuracy of MMA, and the associated biological benefits of this procedure on the upper airway volume, the AHI and general QOL. Moreover, registration of those results could function as a measurement of quality of care, or could be used for sample size calculation for future large multicenter prospective trials.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 6 Months
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- all OSAS patients (AHI ≥ 5) requiring a MMA by Dr. Neyt starting from January 2015
Key inclusion criteria (4 listed)
- Patients of all ages
- Patients of all genders
- Patients diagnosed with OSAS, based on an AHI ≥ 5
- All consecutive OSAS patients operated by N. Neyt from January 2015 onwards
Key exclusion criteria (2 listed)
- Patients not eligible according to abovementioned criteria
- Patients with morbid obesity (BMI >35), if judged non-eligible by the treating surgeon
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
postoperative apnea-hypopnea index, measured with polysomnography
Time frame: 6-12 months
3 secondary outcomes
3D volumetric changes of the upper airway, measured with cone-beam CT
Time frame: 4-6 months
quality of life, measured with epworth sleepiness scale
Time frame: 4-12 months
quality of life, measured with OSAS questionnaire
Time frame: 4-12 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Feb 2022.
- Individual participant dataSharing planned: No
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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.
Araceli Diez-Fraile, MSc, PhD, VMD contact
Nathalie Neyt, MD principal investigator
Division of Maxillofacial Surgery, Department of Surgery, AZ Sint-Jan Brugge-Oostende AV
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Obstructive Sleep Apnea, run by AZ Sint-Jan AV 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 4 inclusion and 2 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: looking for participants now, as of the sponsor's last update on 28 Feb 2022. 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.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Araceli Diez-Fraile, MSc, PhD, VMD (araceli.diez-fraile@azsintjan.be), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
postoperative apnea-hypopnea index, measured with polysomnography (time frame: 6-12 months). 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 Feb 2022.