Virtual Surgery of the Upper Airways

Study Overview
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Brief Summary
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Obstructive sleep apnea (OSA) is a sleep related breathing disorder caused by repetitive collapses of the upper airways resulting in impaired breathing, oxygen desaturation and sleep disturbances. OSA has a massive impact on global health contributing directly to cardiovascular diseases, insulin resistance, metabolic syndrome and daytime fatigue and is repeatedly associated with an increase in motor vehicle accidents. The mainstay of treatment is still the use of positive airway pressure or surgery of the upper airways, but the success rate is persistently low. Surgery may be of help, but there is a lack of patient-specific options in both diagnostics and treatment. Mathematical and computational modeling is expected to provide significant insight into the airway function and onset of OSA. This study is part of a project that will rely on biomedical engineering to obtain the required insight to produce software tools for computer-aided diagnostics and treatment of OSA.

Detailed Description
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This study is the clinical part of a project that contains 4 work packages (WP 1-4). The clinical study (work WP 1) will ensure the inclusion of up to 30 patients with verified sleep apnea that will be in need of either structural nasal surgery, pharyngeal surgery or orthognathic surgery. Studies of nasal airflow and pressure as well as a detailed ConeBeam CT scans of the upper airways will be performed before and after surgery. WP 2, 3 and 4 deals with the mathematical modeling, structural mechanic modeling and the patient-specific airflow modeling.

Official Title
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Virtual Surgery of the Upper Airways-New Solutions to Obstructive Sleep Apnea Treatment

Conditions
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Sleep Apnea, Obstructive

Intervention / Treatment
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* Procedure: functional septorhinoplasty or oropharyngeal/orthognathic surgery


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Obstructive sleep apnea need either functional septorhinoplasty or oropharyngeal/orthognathic surgery in order to establish adequate airway patency have undergone sleep registration using polysomnography and ultrawideband radar on the subsequent clinical evaluation presenting either 1) intranasal obstruction, due to malalignment of the nasal septal cartilage or the nasal outer framework; and/or 2) oropharyngeal obstruction or retrognathia. Exclusion Criteria: previous nasal or oropharyngeal surgery previous use of nasal decongestant or nasal topical steroids over the last 3 months

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Obstructive sleep apnea (OSA)<br>OSA patients who are eligible for either functional septorhinoplasty or oropharyngeal/orthognathic surgery | Procedure: functional septorhinoplasty or oropharyngeal/orthognathic surgery<br>* obtain pre- and postoperative data in order to describe the specific changes in airflow and upper soft tissue behavior that causes sleep apnea<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Apnea-Hypopnea Index (AHI) | AHI is measured by sleep polygraphy in all patients before and after surgery | Baseline and 3 months postoperatively | 
| Upper airway soft tissue characteristics | Specific descriptions of deformation and strain in soft tissues in sleep apnea patients | Up to 3 months postoperatively | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Surgery, Rhinoplasty, Nasal Obstruction, Soft tissue biomechanics