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 Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
48
Maxillary advancement by LeFort I osteotomy and mandibular advancement by bilateral sagittal split osteotomy
Falu Hospital
Falun, Dalarna County, Sweden
RECRUITINGApnea Hypopnea Index (AHI/h)
Change in AHI/h. Lower value means better outcome, value \< 5 is considered healthy.
Time frame: Registration presurgically and at 3 months, 2 years and 5 years post operatively
Upper airway volume
Changes in upper airway volume measured in mm\^3.
Time frame: Registration presurgically and at 3 months, 2 years and 5 years post operatively
Airway velocity
Changes in airway velocity measured in m/s
Time frame: Registration presurgically and at 3 months, 2 years and at 5 years post operatively.
Epworth Sleepiness Scale (ESS)
Assessment of daytime sleepiness using Epworth Sleepiness Scale before and after treatment. Minimum score 0, maximum 24. Higher scores mean a worse outcome,
Time frame: Registration presurgically and at 3 months, 2 years and 5 years post operatively
Blood pressure
Assessment of the effect of surgery on both systolic and diastolic blood pressure and blood pressure medication, mmHg.
Time frame: Registration presurgically and at 3 months, 2 years and 5 years post operatively
Quality of Life (QoL), Short Form-36 Health Survey
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.
Time frame: Registration presurgically and at 3 months, 2 years and 5 years post operatively
Quality of Life (QoL), Oral Health Impact Profile - Swedish version
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.
Time frame: Registration presurgically and at 3 months, 2 years and 5 years post operatively
Quality of Life (QoL), Jaw Function Limitation Scale.
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.
Time frame: Registration presurgically and at 3 months, 2 years and 5 years post operatively
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