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NCT Number: NCT07446634

Maxillomandibular Advancement Surgery for Treatment of Obstructive Sleep Apnoea Syndrome

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.

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Key information

Conditions

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

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Falu Hospital

Falun, Dalarna County, 79182, Sweden

Location status: Recruiting

Location contact

Jani MA Talvilahti, DDS, Head

CONTACT

[email protected]

+46 49 21 08

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Maxillomandibular advancement surgery with counterclockwise rotation

Procedure

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

Primary outcomes

  1. 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.

Secondary outcomes

  1. 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.

  2. 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

  3. 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,

  4. 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.

  5. 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.

  6. 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.

  7. 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.

Study contacts

Contact information is provided by the study sponsor or research team.

Jani M A Talvilahti, DDS, Head

CONTACT

[email protected]

+46 23 49 21 08

Sponsors and collaborators

Lead sponsor

Jani Talvilahti

Other

Registry information

Acronym: OSAS

Important dates

Study start
2014
Primary completion
2031
Study completion
2032
First posted
Mar 3, 2026
Registry last updated
Mar 3, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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