Virtual Surgery of the Upper Airways

Sleep Apnea, Obstructive Clinical Trial

— VirtuOSA  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04829201
• Other study ID #: RCN303218
• Status: Recruiting
• Start date: April 20, 2021
• Est. completion date: December 31, 2024

Study information

• Verified date: November 2023
• Source: Norwegian University of Science and Technology
• Contact: Mads HS Moxness, md phd
• Phone: +47 99035515
• Email: madsmox[@]gmail.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 30
• Est. completion date: December 31, 2024
• Est. primary completion date: August 31, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

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

Related Conditions & MeSH terms

• Sleep Apnea Syndromes
• Sleep Apnea, Obstructive

Intervention

Procedure:
• functional 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

Locations

Country	Name	City	State
Norway	Aleris Solsiden	Trondheim
Norway	St Olavs Hospital	Trondheim	Trøndelag

Sponsors (3)

Lead Sponsor	Collaborator
Norwegian University of Science and Technology	SINTEF Health Research, St. Olavs Hospital

Country where clinical trial is conducted

Norway, 

Outcome

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