Clinical trial NCT04829201: Virtual Surgery of the Upper Airways
Official title: Virtual Surgery of the Upper Airways-New Solutions to Obstructive Sleep Apnea Treatment
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Sleep Apnea, Obstructive
Keywords: Surgery
Rhinoplasty
Nasal Obstruction
Soft tissue biomechanics
Lead sponsor: Norwegian University of Science and Technology
Sponsor class: OTHER
Collaborators: name: SINTEF Health Research
name: St. Olavs Hospital
First posted: 2021-04-02
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: All eligible patients within the community of Mid-Norway referred to the sleep clinic from primary or secondary care facilities.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Change in Apnea-Hypopnea Index (AHI)
timeFrame: Baseline and 3 months postoperatively
measure: Upper airway soft tissue characteristics
timeFrame: Up to 3 months postoperatively
Secondary outcomes:
Other outcomes:
Locations:
city: Trondheim
country: Norway
facility: St Olavs Hospital
state: Trøndelag
city: Trondheim
country: Norway
facility: Aleris Solsiden
Study officials:
affiliation: NTNU, Fac IV, Dept of Structural Engineering
name: Bjørn H Skallerud, phd prof
role: STUDY_DIRECTOR
affiliation: NTNU, Fac MH, Dept of Neuromedicine and Movement Science
name: Ståle Nordgård, phd prof
role: PRINCIPAL_INVESTIGATOR
affiliation: NTNU, Fac IV, Dept of Energy and Process Engineering
name: Bernhard Müller, phd prof
role: PRINCIPAL_INVESTIGATOR
affiliation: SINTEF Health Research
name: Sverre G Johnsen, phd
role: PRINCIPAL_INVESTIGATOR
affiliation: St Olavs Hospital, Clinic Ear Nose and Throat
name: Ståle Nordgård, phd prof
role: STUDY_DIRECTOR
References: