Sleep Apnea, Obstructive
Conditions
Keywords
Surgery, Rhinoplasty, Nasal Obstruction, Soft tissue biomechanics
Brief summary
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
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.
Interventions
PROCEDUREfunctional septorhinoplasty or oropharyngeal/orthognathic surgery
obtain pre- and postoperative data in order to describe the specific changes in airflow and upper soft tissue behavior that causes sleep apnea
Sponsors
SINTEF Health Research
St. Olavs Hospital
Norwegian University of Science and Technology
Study design
Observational model
CASE_ONLY
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in Apnea-Hypopnea Index (AHI) | Baseline and 3 months postoperatively | AHI is measured by sleep polygraphy in all patients before and after surgery |
| Upper airway soft tissue characteristics | Up to 3 months postoperatively | Specific descriptions of deformation and strain in soft tissues in sleep apnea patients |
Countries
Norway
Contacts
Primary ContactMads HS Moxness, md phd
Backup ContactStåle Nordgård, phd prof
Outcome results
None listed