Maxillomandibular Advancement Surgery for Treatment of Obstructive Sleep Apnoea Syndrome

NCT07446634 | Recruiting

• 1 other identifier: 2013/125
• Study Type: interventional
• Target: 48
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Sleep Apnea, Obstructive

Keywords

Sleep Apnea; Orthognathic Surgical Procedure; Tomography; Computational Fluid Dynamics

Outcome Measures

Primary Outcomes (1)

• Apnea Hypopnea Index (AHI/h)

  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 Outcomes (7)

• Upper airway volume

  Registration presurgically and at 3 months, 2 years and 5 years post operatively

• Airway velocity

  Registration presurgically and at 3 months, 2 years and at 5 years post operatively.

• Epworth Sleepiness Scale (ESS)

  Registration presurgically and at 3 months, 2 years and 5 years post operatively

• Blood pressure

  Registration presurgically and at 3 months, 2 years and 5 years post operatively

• Quality of Life (QoL), Short Form-36 Health Survey

  Registration presurgically and at 3 months, 2 years and 5 years post operatively

Study Arms (1)

Intervention

EXPERIMENTAL

Single arm study with counterclockwise rotational maxillo-mandibular advancement surgery

Procedure: Maxillomandibular advancement surgery with counterclockwise rotation

Interventions

Maxillomandibular advancement surgery with counterclockwise rotation PROCEDURE

Maxillary advancement by LeFort I osteotomy and mandibular advancement by bilateral sagittal split osteotomy

Intervention

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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.

Sponsors & Collaborators

• Jani Talvilahti: lead

Study Sites (1)

Falu Hospital

Falun, Dalarna County, 79182, Sweden

RECRUITING

MeSH Terms

Conditions

Sleep Apnea, Obstructive; Sleep Apnea Syndromes

Condition Hierarchy (Ancestors)

Apnea; Respiration Disorders; Respiratory Tract Diseases; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Nervous System Diseases

Study Officials

• Andreas Thor, Professor

  Department of Surgical Sciences, Oral and Maxillofacial Surgery, Uppsala University, Uppsala, Sweden.

  STUDY CHAIR

Central Study Contacts

Jani M A Talvilahti, DDS, Head

CONTACT

+46 23 49 21 08; jani.talvilahti@regiondalarna.se

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Head of Maxillofacial Surgery, DDS

Model Details: Prospective singel center study

Study Record Dates

• First Submitted: February 11, 2026
• First Posted: March 3, 2026
• Study Start: February 6, 2014
• Primary Completion (Estimated): June 30, 2031
• Study Completion (Estimated): June 30, 2032
• Last Updated: March 3, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will not share

Locations

SE (1)