Diakonessenhuis
Utrecht, 3582KE, Netherlands
Location status: Recruiting
Location contact
Haya Al-Bayyati
SUB_INVESTIGATOR
Maurits de Ruiter, MD, DDS, PHD
PRINCIPAL_INVESTIGATOR
Susanne Leij
CONTACT
NCT Number: NCT06386341
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.
Interested in participating?
Request Info18 year and older
All sexes
Observational
Utrecht, 3582KE, Netherlands
Location status: Recruiting
Haya Al-Bayyati
SUB_INVESTIGATOR
Maurits de Ruiter, MD, DDS, PHD
PRINCIPAL_INVESTIGATOR
Susanne Leij
CONTACT
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.
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Surgery where the upper and lower jaw are repositioned.
Time frame: 5 minutes
Survey
Time frame: 5 minutes
Survey
Time frame: 5 minutes
Survey
Time frame: 5 minutes
Survey
Time frame: 5 minutes
Survey
Time frame: 5 minutes
Survey
Diakonessenhuis, Utrecht
Other
Quality of Life in Obstructive Sleep Apnea patiënts Treated With Maxillomandibular Advancement Surgery.
Acronym: QOMAS
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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