An observational study in Sleep Apnea, Obstructive and Quality of Life, sponsored by Diakonessenhuis, Utrecht. Recruiting at 1 site in Netherlands. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2024-04-26.
Sponsored by Diakonessenhuis, Utrecht · Observational
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.
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:
Exclusion criteria for this research:
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.
1,422 studies on the registry are indexed under Apnea; 159 are open to participants now.
This study's planned enrollment of 80 is below the median of 106 across 386 observational studies indexed under Apnea.
Browse Apnea studies →Diakonessenhuis, Utrecht is the lead sponsor of 8 studies on the registry; 4 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Patients undergoing maxillomandibular advancement surgery for OSA (intervention group) or other reasons (control group).
Exclusion Criteria:
Patiënts who underwent MMA surgery for OSA.
Procedure: Maxillomandibular Advancement Surgery
Patiënts who underwent MMA surgery for other reasons than OSA.
Procedure: Maxillomandibular Advancement Surgery
Surgery where the upper and lower jaw are repositioned.
SF-36
Survey
Time frame: 5 minutes
OHIP-14
Survey
Time frame: 5 minutes
ESS
Survey
Time frame: 5 minutes
FOSQ
Survey
Time frame: 5 minutes
EQ-5D-3L
Survey
Time frame: 5 minutes
OQLQ
Survey
Time frame: 5 minutes
Plan to share: No
No publications or documents are linked to this record.
Eligibility is decided by the study team. Share this record with your doctor or contact the team directly.
No contact was published for this record. The registry link below has the sponsor’s details.
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Diakonessenhuis, Utrecht