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Maxillomandibular Advancement Surgery for Treatment of Obstructive Sleep Apnoea Syndrome

RecruitingNAAges 18 Years - 70 YearsAllJani Talvilahti
NCT07446634 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

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.

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📋 Eligibility rules (as published)
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.
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What it tests

  • Maxillomandibular advancement surgery with counterclockwise rotation
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Where

1 site
Falu Hospital
Falun, Sweden
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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