Sleep Apnea, Obstructive
Conditions
Keywords
Sleep Apnea, Orthognathic Surgical Procedure, Tomography, Computational Fluid Dynamics
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.
Interventions
PROCEDUREMaxillomandibular advancement surgery with counterclockwise rotation
Maxillary advancement by LeFort I osteotomy and mandibular advancement by bilateral sagittal split osteotomy
Sponsors
Jani Talvilahti
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
Prospective singel center study
Eligibility
Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Apnea Hypopnea Index (AHI/h) | 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
| Measure | Time frame | Description |
|---|---|---|
| Upper airway volume | Registration presurgically and at 3 months, 2 years and 5 years post operatively | Changes in upper airway volume measured in mm\^3. |
| Airway velocity | Registration presurgically and at 3 months, 2 years and at 5 years post operatively. | Changes in airway velocity measured in m/s |
| Epworth Sleepiness Scale (ESS) | 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, |
| Blood pressure | 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. |
| Quality of Life (QoL), Short Form-36 Health Survey | 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. |
| Quality of Life (QoL), Oral Health Impact Profile - Swedish version | 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. |
| Quality of Life (QoL), Jaw Function Limitation Scale. | 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. |
Countries
Sweden
Contacts
CONTACTJani M A Talvilahti, DDS, Head
STUDY_CHAIRAndreas Thor, Professor
Department of Surgical Sciences, Oral and Maxillofacial Surgery, Uppsala University, Uppsala, Sweden.
Outcome results
None listed