QoL in OSA patiënts Treated With MMA Surgery.
QOMAS
Quality of Life in Obstructive Sleep Apnea patiënts Treated With Maxillomandibular Advancement Surgery.
1 other identifier
observational
80
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for all trials
Started Aug 2023
Typical duration for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
August 2, 2023
CompletedFirst Submitted
Initial submission to the registry
April 23, 2024
CompletedFirst Posted
Study publicly available on registry
April 26, 2024
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 2, 2026
ExpectedStudy Completion
Last participant's last visit for all outcomes
August 2, 2026
April 26, 2024
August 1, 2023
3 years
April 23, 2024
April 23, 2024
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
SF-36
Survey
5 minutes
Secondary Outcomes (5)
OHIP-14
5 minutes
ESS
5 minutes
FOSQ
5 minutes
EQ-5D-3L
5 minutes
OQLQ
5 minutes
Study Arms (2)
Intervention group
Patiënts who underwent MMA surgery for OSA.
Control group
Patiënts who underwent MMA surgery for other reasons than OSA.
Interventions
Surgery where the upper and lower jaw are repositioned.
Eligibility Criteria
Patients undergoing maxillomandibular advancement surgery for OSA (intervention group) or other reasons (control group).
You may qualify if:
- 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)
- Expected to maintain current lifestyle (sports, medicine, diet etc.).
- Qualifies for MMA surgery
- Patients who provide informed consent
You may not qualify if:
- 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
- +3 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Diakonessenhuis
Utrecht, 3582KE, Netherlands
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Target Duration
- 3 Years
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
April 23, 2024
First Posted
April 26, 2024
Study Start
August 2, 2023
Primary Completion (Estimated)
August 2, 2026
Study Completion (Estimated)
August 2, 2026
Last Updated
April 26, 2024
Record last verified: 2023-08
Data Sharing
- IPD Sharing
- Will not share