Ignite Creation Date:
2024-05-06 @ 8:26 PM
Last Modification Date:
2024-10-26 @ 3:28 PM
Study NCT ID:
NCT06386341
Status:
RECRUITING
Last Update Posted:
2024-04-26
First Post:
2024-04-23
Brief Title:
QoL in OSA patiënts Treated With MMA Surgery
Sponsor:
Diakonessenhuis Utrecht
Organization:
Diakonessenhuis Utrecht
Study Overview
Official Title:
Quality of Life in Obstructive Sleep Apnea patiënts Treated With Maxillomandibular Advancement Surgery
Status:
RECRUITING
Status Verified Date:
2023-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
QOMAS
Brief 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 about their QoL and there will be data collected like length weight and blood pressure
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 studyThere will also be a control groupThese 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 eg 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
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 studyThere will also be a control groupThese 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 eg 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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None