Maxillomandibular Advancement Surgery for Treatment of Obstructive Sleep Apnoea Syndrome (OSAS)

February 25, 2026 updated by: Jani Talvilahti
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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

48

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Sweden
    • Dalarna County
      • Falun, Dalarna County, Sweden, 79182

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Intervention
Single arm study with counterclockwise rotational maxillo-mandibular advancement surgery
Procedure: Maxillomandibular advancement surgery with counterclockwise rotation
Maxillary advancement by LeFort I osteotomy and mandibular advancement by bilateral sagittal split osteotomy

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Apnea Hypopnea Index (AHI/h)
Time Frame: Registration presurgically and at 3 months, 2 years and 5 years post operatively
Change in AHI/h. Lower value means better outcome, value < 5 is considered healthy.
Registration presurgically and at 3 months, 2 years and 5 years post operatively

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Upper airway volume
Time Frame: Registration presurgically and at 3 months, 2 years and 5 years post operatively
Changes in upper airway volume measured in mm^3.
Registration presurgically and at 3 months, 2 years and 5 years post operatively
Airway velocity
Time Frame: Registration presurgically and at 3 months, 2 years and at 5 years post operatively.
Changes in airway velocity measured in m/s
Registration presurgically and at 3 months, 2 years and at 5 years post operatively.
Epworth Sleepiness Scale (ESS)
Time Frame: Registration presurgically and at 3 months, 2 years and 5 years post operatively
Assessment of daytime sleepiness using Epworth Sleepiness Scale before and after treatment. Minimum score 0, maximum 24. Higher scores mean a worse outcome,
Registration presurgically and at 3 months, 2 years and 5 years post operatively
Blood pressure
Time Frame: Registration presurgically and at 3 months, 2 years and 5 years post operatively
Assessment of the effect of surgery on both systolic and diastolic blood pressure and blood pressure medication, mmHg.
Registration presurgically and at 3 months, 2 years and 5 years post operatively
Quality of Life (QoL), Short Form-36 Health Survey
Time Frame: Registration presurgically and at 3 months, 2 years and 5 years post operatively
Evaluation of participants Quality of Life through validated questionnaire 36-Item Short Form Health Survey (SF-36). SF-36 is a self-reported questionnaire designed to measure generic health-related quality of life across eight domains, such as physical functioning, bodily pain, and mental health. Higher score means worse outcome.
Registration presurgically and at 3 months, 2 years and 5 years post operatively
Quality of Life (QoL), Oral Health Impact Profile - Swedish version
Time Frame: Registration presurgically and at 3 months, 2 years and 5 years post operatively
Evaluation of participants Quality of Life through validated questionnaire Oral Health Impact Profile-49 - Swedish version (OHIP-S). It is a comprehensive instrument designed to measure oral health-related quality of life (OHRQoL) across seven dimensions: functional limitation, physical pain, psychological discomfort, physical disability, psychological disability, social disability, and handicap. Higher score means worse outcome.
Registration presurgically and at 3 months, 2 years and 5 years post operatively
Quality of Life (QoL), Jaw Function Limitation Scale.
Time Frame: Registration presurgically and at 3 months, 2 years and 5 years post operatively
Evaluation of participants Quality of Life through validated questionnaire Jaw Functional Limitation Scale (JFLS). JFLS is a patient-reported instrument used to assess functional status and limitations of the masticatory system (the jaw), typically in individuals with temporomandibular disorders. Higher score means worse outcome.
Registration presurgically and at 3 months, 2 years and 5 years post operatively

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Jani Talvilahti

Investigators

  • Study Chair: Andreas Thor, Professor, Department of Surgical Sciences, Oral and Maxillofacial Surgery, Uppsala University, Uppsala, Sweden.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 6, 2014

Primary Completion (Estimated)

June 30, 2031

Study Completion (Estimated)

June 30, 2032

Study Registration Dates

First Submitted

February 11, 2026

First Submitted That Met QC Criteria

February 25, 2026

First Posted (Actual)

March 3, 2026

Study Record Updates

Last Update Posted (Actual)

March 3, 2026

Last Update Submitted That Met QC Criteria

February 25, 2026

Last Verified

February 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2013/125

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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