Evaluating quality of life after maxillomandibular advancement surgery for sleep apnea
Quality of Life in Obstructive Sleep Apnea patiënts Treated With Maxillomandibular Advancement Surgery.
Diakonessenhuis, Utrecht · NCT06386341
This study is testing if maxillomandibular advancement surgery can improve the quality of life for people with obstructive sleep apnea by comparing their experiences before and after the surgery.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 80 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Diakonessenhuis, Utrecht (other) |
| Drugs / interventions | radiation |
| Locations | 1 site (Utrecht) |
| Trial ID | NCT06386341 on ClinicalTrials.gov |
What this trial studies
This observational study aims to assess the impact of maxillomandibular advancement (MMA) surgery on the quality of life in patients suffering from obstructive sleep apnea (OSA). Participants will complete online surveys to evaluate their quality of life using various questionnaires, including the SF-36, OHIP-14, and EQ-5D-3L. The study will involve 80 patients who qualify for MMA surgery and a control group of patients without OSA, with data collected on their health metrics such as height, weight, and blood pressure. The goal is to determine whether MMA surgery leads to significant improvements in quality of life for OSA patients.
Who should consider this trial
Good fit: Ideal candidates for this study are adults over 18 years old who have been diagnosed with obstructive sleep apnea and qualify for MMA surgery.
Not a fit: Patients who do not qualify for MMA surgery or have other severe medical conditions may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide evidence that MMA surgery significantly enhances the quality of life for patients with obstructive sleep apnea.
How similar studies have performed: While there have been studies on MMA surgery for OSA, this specific observational approach focusing on quality of life outcomes is relatively novel.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Utrecht
- Diakonessenhuis — Utrecht, Netherlands (RECRUITING)
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Sleep Apnea, Obstructive, Quality of Life, Surgery, Oral