Jaw advancement with counterclockwise rotation for obstructive sleep apnea
Official title: Maxillomandibular Advancement Surgery for Treatment of Obstructive Sleep Apnoea Syndrome
Run by Dalarna County Council, Sweden · NCT07446634 · Data updated 2026-11-12
This trial tests whether jaw advancement surgery with counterclockwise rotation helps people with moderate to severe obstructive sleep apnea who can't tolerate CPAP breathe better and sleep more soundly.
Quick facts
| Study type | Interventional |
|---|---|
| Ages | 18 Years to 70 Years |
| Sex | All |
| Enrollment | 48 (estimated) |
| Sponsor | Dalarna County Council, Sweden Academic / other |
| Locations | 1 site (Falun, Dalarna County) |
| Status | Recruiting |
| Started | February 6, 2014 |
| Main results expected | June 30, 2031 |
| Study ends | June 30, 2032 |
| Registry record updated | March 3, 2026 |
| Trial ID | NCT07446634 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates are adults with obstructive sleep apnea (AHI ≥15), BMI between 15 and 35, documented failure of CPAP or mandibular advancement therapy, residency/registration in Dalarna County, and no contraindications to general anesthesia or prior orthognathic surgery.
✕Probably not a fit
Patients with central sleep apnea, ASA Class III–V or other contraindications to general anesthesia, prior orthognathic surgery, BMI over 35, or systemic conditions associated with increased OSA risk (for example untreated hypothyroidism, acromegaly, uncontrolled diabetes) are unlikely to benefit from this procedure.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
Adults with moderate to severe obstructive sleep apnea who have failed CPAP or mandibular advancement therapy will undergo maxillomandibular advancement with counterclockwise rotation and be followed over time. Outcomes include changes in sleep apnea severity, daytime sleepiness, and airway dimensions using advanced three-dimensional imaging and computational fluid dynamics. The study tracks both short- and long-term safety and durability of symptom improvements. Procedures and follow-up are conducted at Falu Hospital in Dalarna County.
Why it matters
Potential benefit: If successful, the surgery could reduce apnea events, lessen daytime sleepiness, and enlarge the upper airway, offering a long-term option for patients who cannot use CPAP.
How similar studies have gone: Previous studies have shown maxillomandibular advancement often produces substantial and durable reductions in AHI and symptoms, and this protocol builds on that evidence while adding counterclockwise rotation and detailed airflow imaging.
Who can join: the full rules
Show full inclusion / exclusion criteria
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.
Where it's running
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Falu Hospital
Falun, Dalarna County, Sweden Recruiting
Study contacts
- Study coordinator: Jani M A Talvilahti, DDS, Head
- Email: jani.talvilahti@regiondalarna.se
- Phone: +46 23 49 21 08
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.