Maxillomandibular Advancement Surgery for Treatment of Obstructive Sleep Apnoea Syndrome (NCT07446634) | Clinical Trial Compass
RecruitingNot Applicable
Maxillomandibular Advancement Surgery for Treatment of Obstructive Sleep Apnoea Syndrome
Sweden48 participantsStarted 2014-02-06
Plain-language summary
This study looks at how jaw surgery called maxillomandibular advancement with counterclockwise rotation affects breathing during sleep in people with moderate to severe obstructive sleep apnea who cannot tolerate standard treatments such as Continous Positive Airway pressure treatment. The participants are followed over time to see whether the surgery improves sleep apnea symptoms, daytime sleepiness, and airway size, and whether these improvements last. Advanced three-dimensional imaging and airflow analysis are used to better understand how the surgery changes the airway and breathing. The goal is to evaluate the long-term effectiveness and safety of this surgical treatment.
Who can participate
Age range
18 Years – 70 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Clinical diagnosis of obstructive sleep apnea with AHI ≥15 events/h.
* Residence and/or registration in Dalarna County
* Body mass index (BMI; kg/m\^2) between 15 and 35
* Documented failure of CPAP or mandibular advancement therapy.
Exclusion Criteria:
* Medical conditions contraindicating general anesthesia.
* American Society of Anesthesiologists Physical Status (ASA) Class III-VI
* Central sleep apnea
* Narcolepsy
* Prior orthognathic surgery
* History of tumor disease or radiotherapy of the jaws. Participants with systemic conditions associated with an increased risk of OSA. Such risks include;
* Hypothyroidism
* Acromegaly
* Diabetes mellitus
* Active generalized rheumatoid arthritis
* Clinically manifest periodic limb movement disorder
* Restless legs syndrome.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Apnea Hypopnea Index (AHI/h)
Timeframe: Registration presurgically and at 3 months, 2 years and 5 years post operatively