Maxillomandibular Advancement Surgery for Treatment of Obstructive Sleep Apnoea Syndrome
Recruiting now · Not applicable
Conditions studied: Sleep Apnea, Obstructive
In brief
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.
Key facts
- Study ID
- NCT07446634
- Run by
- Jani Talvilahti
- People needed
- 48
- Starts
- 2014-02-06
- Expected to finish
- 2032-06-30
- Last updated by the study team
- 2026-03-03
Who can join
Age: 18 and older, up to 70. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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.
You may not qualify if…
- 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.
Where it is running
- Falu Hospital — Falun, Dalarna County, Sweden (enrolling)
Full record on ClinicalTrials.gov
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