Maxillomandibular Advancement Surgery for Treatment of Obstructive Sleep Apnoea Syndrome

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-70
SponsorJani Talvilahti

About this trial

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.

Eligibility criteria

Qualifiers

Clinical diagnosis of obstructive sleep apnea with AHI ≥15 events/h.

Residence and/or registration in Dalarna County

Body mass index (BMI; kg/m²) between 15 and 35

Documented failure of CPAP or mandibular advancement therapy.

Disqualifiers

Medical conditions contraindicating general anesthesia.

American Society of Anesthesiologists Physical Status (ASA) Class III-VI

Central sleep apnea

Narcolepsy

Trial design

Treatments tested in this trial

  • Maxillomandibular advancement surgery with counterclockwise rotation

Treatment groups

48 Participants
are divided into 1 treatment group

Sponsors and collaborators

Jani Talvilahti

Lead sponsor

Dalarna County Council, Sweden

Sponsor institution