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Jaw surgery for obstructive sleep apnea in people who cannot use standard treatment

Tests jaw advancement surgery in adults with obstructive sleep apnea who cannot tolerate CPAP.

Key facts

Who runs it
Jani Talvilahti
Where
Sweden1 site in 1 countryChoose a country to see its sites
Trial code
Registry title
Maxillomandibular Advancement Surgery for Treatment of Obstructive Sleep Apnoea Syndrome
Status
Recruiting
People taking part
48 people, planned
Started
6 Feb 2014
Expected to end
30 Jun 2032
Type of study
Interventional
Treatments tested
  • Maxillomandibular advancement surgery with counterclockwise rotation
Record updated
3 March 2026

Who can take part

AI summary

From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.

The trial is looking for adults with moderate to severe obstructive sleep apnea who could not use CPAP or a jaw-advancing mouth device. They will have jaw surgery that moves both jaws forward.

Age
18 Years to 70 Years
Sex
All sexes can join.
Disease stage
Obstructive sleep apnea with AHI ≥15 events/h (breathing pauses per hour of sleep). Body mass index between 15 and 35 kg/m^2. People must live or be registered in Dalarna County.
Earlier treatment
CPAP or mandibular advancement therapy must have been tried and documented as failed. People who already had orthognathic (jaw) surgery cannot join.

Main reasons for not taking part

  • Health problems that rule out general anesthesia, or ASA Class III-VI
  • Central sleep apnea or narcolepsy
  • Past tumor disease or radiotherapy of the jaws
  • Hypothyroidism, acromegaly, diabetes mellitus or active generalized rheumatoid arthritis
  • Periodic limb movement disorder or restless legs syndrome

The registry criteria, word for word

Show all 16 criteriaShow less

Who can take part

  • 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

Who cannot take part

  • Prior orthognathic surgery
  • Medical conditions contraindicating general anesthesia
  • History of tumor disease or radiotherapy of the jaws. Participants with systemic conditions associated with an increased risk of OSA. Such risks include
  • Diabetes mellitus
  • Clinically manifest periodic limb movement disorder
  • Restless legs syndrome
  • American Society of Anesthesiologists Physical Status (ASA) Class III-VI
  • Central sleep apnea
  • Narcolepsy
  • Hypothyroidism
  • Acromegaly
  • Active generalized rheumatoid arthritis

Check if you might fit

Answer for yourself. This is not a decision: only the study team can say whether you can take part.

  • Are you between 18 and 70 years old?

This trial has no sites in United States.

It has sites in one country. Choose a country to see its sites.

About the trial

What the trial wants to find out

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.

The group in the trial

  • InterventionTreatment being tested

    Single arm study with counterclockwise rotational maxillo-mandibular advancement surgery

    Treatment: Maxillomandibular advancement surgery with counterclockwise rotation

Questions to ask the study team

  1. How often do I need to come in, and for how long each time?
  2. Are travel costs paid?
  3. Can I keep my own doctor?
  4. What happens if I want to stop?

Contact the study team: see the registry record → Contacts and Locations

Print a page for my doctor

Data and sources

Registry record
Listed on ClinicalTrials.gov.
Official title
Maxillomandibular Advancement Surgery for Treatment of Obstructive Sleep Apnoea Syndrome
Plain-language title
Jaw surgery for obstructive sleep apnea in people who cannot use standard treatmentGenerated from the registry record. The registry title is the official one.
AI summary
From the trial's eligibility criteria. Read by machine on 14 November 2026.
Fit questions
Built from NCT07446634, who can take part
Record updated
3 March 2026