NCT06386341 QoL in OSA patiënts Treated With MMA Surgery.
| NCT ID | NCT06386341 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Diakonessenhuis, Utrecht |
| Condition | Sleep Apnea, Obstructive |
| Study Type | OBSERVATIONAL |
| Enrollment | 80 participants |
| Start Date | 2023-08-02 |
| Primary Completion | 2026-08-02 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 80 participants in total. It began in 2023-08-02 with a primary completion date of 2026-08-02.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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.
Eligibility Criteria
Inclusion Criteria: * 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) * Expected to maintain current lifestyle (sports, medicine, diet etc.). * Qualifies for MMA surgery * Patients who provide informed consent Exclusion Criteria: * 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
Frequently Asked Questions
Who can join the NCT06386341 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Sleep Apnea, Obstructive. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06386341 currently recruiting?
Yes, NCT06386341 is actively recruiting participants. Visit ClinicalTrials.gov or contact Diakonessenhuis, Utrecht to inquire about joining.
Where is the NCT06386341 trial being conducted?
This trial is being conducted at Utrecht, Netherlands.
Who is sponsoring the NCT06386341 clinical trial?
NCT06386341 is sponsored by Diakonessenhuis, Utrecht. The trial plans to enroll 80 participants.