Virtual Surgery of the Upper Airways (VirtuOSA)

Norwegian University of Science and Technology

Status

Enrolling

Conditions

Sleep Apnea, Obstructive

Treatments

Procedure: functional septorhinoplasty or oropharyngeal/orthognathic surgery

Study type

Observational

Funder types

Other

Identifiers

NCT04829201

RCN303218

Details and patient eligibility

About

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.

Full 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.

Enrollment

30 estimated patients

Sex

All

Ages

18 to 70 years old

Volunteers

No Healthy Volunteers

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