Sleep Apnea, ObstructiveQOMASNCT06386341
QoL in OSA patiënts Treated With MMA Surgery.
An observational study of Sleep Apnea, Obstructive and Quality of Life, run by Diakonessenhuis, Utrecht at 1 site in Netherlands.
Trial summary
The aim of this observational study is to evaluate the impact of maxillomandibular advancement surgery on the quality of life in patients treated with obstructive sleep apnea. The main question it aims to answer is: Does MMA surgery in OSA patiënts improve their quality of life? Patients will answer online surverys… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Sleep Apnea, Obstructive, Quality of Life
- What is being tested?
- Maxillomandibular Advancement Surgery
- Type of treatment
- Surgery or procedure
- How many people
- 80 participants
- Where
- 1 siteNetherlands
- Study dates
- 2 Aug 2023to 2 Aug 2026
- How long will I take part?
- 3 Years
- Phase
- Observational
- 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
- Healthy volunteers accepted
- Adult, Older adult
Study population: Patients undergoing maxillomandibular advancement surgery for OSA (intervention group) or other reasons (control group).
Who may be able to join
- 18 years and older.
- Ability to speak, read and write Dutch.
- Ability to follow up.
- Ability to use a computer with internet connection and windows-software for uploading data
- and online questionnaires.
- Diagnosis with OSA. (only for the intervention group)
Show all 9Show fewer
- Expected to maintain current lifestyle (sports, medicine, diet etc.).
- Qualifies for MMA surgery
- Patients who provide informed consent
Who cannot join
- Patients who do not qualify for MMA surgery
- Medication used/ related to sleeping disorders.
- Night or shifting work.
- Severe chronic heart failure.
- Medical history of known causes of tiredness by day or severe sleep disruption (insomnia,
- PLMS, Narcolepsy).
Show all 18Show fewer
- Seizure disorder.
- Known medical history of mental retardation, memory disorders or psychiatric disorders.
- Patients with old type of pacemakers (It is possible that old types of peacemakers are not
- Compatible with the electromagnetic radiation of the electronics of the SPT).
- Shoulder, neck and back complaints.
- Reversible morphological upper airway abnormalities (e.g. enlarged tonsils).
- Inability to provide informed consent.
- Simultaneous use of other treatment modalities to treat OSA.
- Previous treatment for OSA with MRA or SPT
- Pregnancy.
- patients under the age of 18
- Patients with mild or no OSA at all
Trial locations and contacts
1 site in 1 country.
Netherlands1 site, 1 recruiting
- Recruiting
Diakonessenhuis
Utrecht, 3582KE
Susanne Leij, 088-250 6172, sleij@diakhuis.nl
Maurits de Ruiter, MD, DDS, PHD
About this study
Official title: Quality of Life in Obstructive Sleep Apnea patiënts Treated With Maxillomandibular Advancement Surgery.
The aim of this observational study is to evaluate the impact of maxillomandibular advancement surgery on the quality of life in patients treated with obstructive sleep apnea.
The main question it aims to answer is:
Does MMA surgery in OSA patiënts improve their quality of life?
Patients will answer online surverys about their QoL and there will be data collected like length, weight and blood pressure.
Read the detailed description
The aim of this study is to evaluate the impact of MMA surgery on the quality of life of patients with obstructive sleep apnea.
It was hypnotized that MMA does not result in a significant improvement in the quality of life in patients with OSA.
The main objective is the SF-36 questionnaire The secondary objectives are the; OHIP-14, ESS, FOSQ, EQ-5D-3L and OQLQ
Design: observational study
Study population: 80 Patients who qualify for MMA above the age of 18
The patients will be recruited at the departments of Oral and Maxillofacial surgery. Individuals who match the next inclusion and exclusion criteria will be the population base of this study.There will also be a control group.These patients will have the same inclusion and exclusion criteria next to the diagnosis with OSA. The control group will be a group of patients without OSA.
Inclusion criteria for this research are:
- 18 years and older.
- Ability to speak, read and write Dutch.
- Ability to follow up.
- Ability to use a mobile device with internet connection for the online questionnaires.
- Diagnosis with OSA. (only for the intervention group)
- Expected to maintain current lifestyle (sports, medicine, diet etc.).
- Qualifies for MMA surgery
- Patients who provide informed consent
Exclusion criteria for this research:
- Patients who do not qualify for MMA surgery
- Medication used/ related to sleeping disorders.
- Night or shifting work.
- Severe chronic heart failure.
- Medical history of known causes of tiredness by day or severe sleep disruption (insomnia,
- PLMS, Narcolepsy).
- Seizure disorder.
- Known medical history of mental retardation, memory disorders or psychiatric disorders.
- Patients with old type of pacemakers (It is possible that old types of peacemakers are not
- Compatible with the electromagnetic radiation of the electronics of the SPT).
- Shoulder, neck and back complaints.
- Reversible morphological upper airway abnormalities (e.g. enlarged tonsils).
- Inability to provide informed consent.
- Simultaneous use of other treatment modalities to treat OSA.
- Previous treatment for OSA with MRA or SPT
- Pregnancy.
- patients under the age of 18
- Patients with mild or no OSA at all (if patient meets this criteria they will be part of the control group)
In total there will be 80 patients included.
There will be no intervention done for the purpose of this study. But the intervention that will be observed is how the MMA effects the Quality of Life of the patients who underwent this surgery. We are going to prospective observe them and follow them up through their procedure.
The responsible researcher will introduce the research to the patients. When patients meet the inclusion criteria they will be asked to participate in the research. The decision regarding participation in the study, which is made by the patient, is entirely voluntary. Patients are given two weeks time to consider joining the study population. Refusal of participation will have no consequences for further treatment of the patient. They will be asked to sign informed consent.
- Conditions
- Sleep Apnea, Obstructive, Quality of Life
- Being tested
- Maxillomandibular Advancement Surgery
- Keywords
- Sleep Apnea, Obstructive, Quality of Life, Surgery, Oral
- 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.
Maxillomandibular Advancement SurgeryProcedure or surgery
Surgery where the upper and lower jaw are repositioned.
| Study group | Role | What they receive |
|---|---|---|
| Intervention group | Patiënts who underwent MMA surgery for OSA. Receives: Procedure: Maxillomandibular Advancement Surgery | |
| Control group | Patiënts who underwent MMA surgery for other reasons than OSA. Receives: Procedure: Maxillomandibular Advancement Surgery |
What is being measured
The primary outcome is the main question the study is designed to answer.
SF-36
Survey
Measured: 5 minutes
Secondary outcomes (5)
OHIP-14
Survey
Measured: 5 minutes
ESS
Survey
Measured: 5 minutes
FOSQ
Survey
Measured: 5 minutes
EQ-5D-3L
Survey
Measured: 5 minutes
OQLQ
Survey
Measured: 5 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Apr 2024
- Study start2 Aug 2023
- Primary completion2 Aug 2026 (estimated)
- Study completion2 Aug 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Sleep Apnea, ObstructiveStudies 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
- 80 participants (estimated)
- Target duration
- 3 Years
Sponsor and investigators
- Lead sponsor
- Diakonessenhuis, Utrecht
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06386341
- Sponsor's protocol ID
- W23.154
- Acronym
- QOMAS
- Status last verified
- Aug 2023
- First submitted
- 23 Apr 2024
- Last updated
- 26 Apr 2024
- 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 26 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Quality of Life in Obstructive Sleep Apnea patiënts Treated With Maxillomandibular Advancement Surgery.
- ClinicalTrials.gov ID
- NCT06386341
- Acronym / sponsor ID
- QOMAS / W23.154
- Conditions
- Sleep Apnea, Obstructive, Quality of Life
- Keywords
- Sleep Apnea, Obstructive, Quality of Life, Surgery, Oral
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- Diakonessenhuis, UtrechtUniversity, hospital or other
- Study start
- 2 Aug 2023 (actual)
- Primary completion
- 2 Aug 2026 (estimated)
- Study completion
- 2 Aug 2026 (estimated)
- First posted
- 26 Apr 2024 (actual)
- 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.
The aim of this observational study is to evaluate the impact of maxillomandibular advancement surgery on the quality of life in patients treated with obstructive sleep apnea.
The main question it aims to answer is:
Does MMA surgery in OSA patiënts improve their quality of life?
Patients will answer online surverys about their QoL and there will be data collected like length, weight and blood pressure.
Detailed description
The aim of this study is to evaluate the impact of MMA surgery on the quality of life of patients with obstructive sleep apnea.
It was hypnotized that MMA does not result in a significant improvement in the quality of life in patients with OSA.
The main objective is the SF-36 questionnaire The secondary objectives are the; OHIP-14, ESS, FOSQ, EQ-5D-3L and OQLQ
Design: observational study
Study population: 80 Patients who qualify for MMA above the age of 18
The patients will be recruited at the departments of Oral and Maxillofacial surgery. Individuals who match the next inclusion and exclusion criteria will be the population base of this study.There will also be a control group.These patients will have the same inclusion and exclusion criteria next to the diagnosis with OSA. The control group will be a group of patients without OSA.
Inclusion criteria for this research are:
- 18 years and older.
- Ability to speak, read and write Dutch.
- Ability to follow up.
- Ability to use a mobile device with internet connection for the online questionnaires.
- Diagnosis with OSA. (only for the intervention group)
- Expected to maintain current lifestyle (sports, medicine, diet etc.).
- Qualifies for MMA surgery
- Patients who provide informed consent
Exclusion criteria for this research:
- Patients who do not qualify for MMA surgery
- Medication used/ related to sleeping disorders.
- Night or shifting work.
- Severe chronic heart failure.
- Medical history of known causes of tiredness by day or severe sleep disruption (insomnia,
- PLMS, Narcolepsy).
- Seizure disorder.
- Known medical history of mental retardation, memory disorders or psychiatric disorders.
- Patients with old type of pacemakers (It is possible that old types of peacemakers are not
- Compatible with the electromagnetic radiation of the electronics of the SPT).
- Shoulder, neck and back complaints.
- Reversible morphological upper airway abnormalities (e.g. enlarged tonsils).
- Inability to provide informed consent.
- Simultaneous use of other treatment modalities to treat OSA.
- Previous treatment for OSA with MRA or SPT
- Pregnancy.
- patients under the age of 18
- Patients with mild or no OSA at all (if patient meets this criteria they will be part of the control group)
In total there will be 80 patients included.
There will be no intervention done for the purpose of this study. But the intervention that will be observed is how the MMA effects the Quality of Life of the patients who underwent this surgery. We are going to prospective observe them and follow them up through their procedure.
The responsible researcher will introduce the research to the patients. When patients meet the inclusion criteria they will be asked to participate in the research. The decision regarding participation in the study, which is made by the patient, is entirely voluntary. Patients are given two weeks time to consider joining the study population. Refusal of participation will have no consequences for further treatment of the patient. They will be asked to sign informed consent.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 3 Years
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention group | – | Procedure: Maxillomandibular Advancement SurgeryPatiënts who underwent MMA surgery for OSA. |
| Control group | – | Procedure: Maxillomandibular Advancement SurgeryPatiënts who underwent MMA surgery for other reasons than OSA. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Patients undergoing maxillomandibular advancement surgery for OSA (intervention group) or other reasons (control group).
Key inclusion criteria (9 listed)
- 18 years and older.
- Ability to speak, read and write Dutch.
- Ability to follow up.
- Ability to use a computer with internet connection and windows-software for uploading data
- and online questionnaires.
Key exclusion criteria (18 listed)
- Patients who do not qualify for MMA surgery
- Medication used/ related to sleeping disorders.
- Night or shifting work.
- Severe chronic heart failure.
- Medical history of known causes of tiredness by day or severe sleep disruption (insomnia,
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 |
|---|---|---|
| Maxillomandibular Advancement SurgerySurgery where the upper and lower jaw are repositioned. | Procedure or surgery | Control group, Intervention group |
Primary outcome
SF-36
Time frame: 5 minutes
Survey
5 secondary outcomes
OHIP-14
Time frame: 5 minutes
ESS
Time frame: 5 minutes
FOSQ
Time frame: 5 minutes
EQ-5D-3L
Time frame: 5 minutes
OQLQ
Time frame: 5 minutes
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Apr 2024.
- 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. 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?
An observational study of Sleep Apnea, Obstructive and Quality of Life, run by Diakonessenhuis, Utrecht at 1 site in Netherlands.
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 9 inclusion and 18 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 26 Apr 2024. 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 Netherlands. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
SF-36 (time frame: 5 minutes). 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 26 Apr 2024.