Virtual Surgery of the Upper Airways (VirtuOSA)

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

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.

Study Overview

• Status: Recruiting
• Conditions: Sleep Apnea, Obstructive
• Intervention / Treatment: Procedure: functional septorhinoplasty or oropharyngeal/orthognathic surgery

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.

• Study Type: Observational
• Enrollment (Estimated): 30

Contacts and Locations

• Study Contact: Name: Mads HS Moxness, md phd; Phone Number: +47 99035515; Email: madsmox@gmail.com
• Study Contact Backup: Name: Ståle Nordgård, phd prof; Phone Number: 0047 72880232; Email: stale.nordgard@ntnu.no

Study Locations

• Norway
  • Trondheim, Norway
    • Recruiting
    • Aleris Solsiden
    • Contact: Mads Henrik Strand Moxness, md phd; Email: madsmox@gmail.com
  • Trøndelag
    • Trondheim, Trøndelag, Norway, 7006
      • Recruiting
      • St Olavs Hospital
      • Contact: Mads HS Moxness, md phd; Email: madsmox@gmail.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 70 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

• 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.

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Obstructive sleep apnea (OSA); OSA patients who are eligible for either functional septorhinoplasty or oropharyngeal/orthognathic surgery	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

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Norwegian University of Science and Technology
• Collaborators: St. Olavs Hospital; SINTEF Health Research
• Investigators: Study Director: Bjørn H Skallerud, phd prof, NTNU, Fac IV, Dept of Structural Engineering; Principal Investigator: Ståle Nordgård, phd prof, NTNU, Fac MH, Dept of Neuromedicine and Movement Science; Principal Investigator: Bernhard Müller, phd prof, NTNU, Fac IV, Dept of Energy and Process Engineering; Principal Investigator: Sverre G Johnsen, phd, SINTEF Health Research; Study Director: Ståle Nordgård, phd prof, St Olavs Hospital, Clinic Ear Nose and Throat

Study record dates

Study Major Dates

• Study Start (Actual): April 20, 2021
• Primary Completion (Estimated): August 31, 2024
• Study Completion (Estimated): December 31, 2024

Study Registration Dates

• First Submitted: February 8, 2021
• First Submitted That Met QC Criteria: March 31, 2021
• First Posted (Actual): April 2, 2021

Study Record Updates

• Last Update Posted (Actual): November 3, 2023
• Last Update Submitted That Met QC Criteria: November 2, 2023
• Last Verified: November 1, 2023

More Information

Terms related to this study

• Keywords: Surgery; Nasal Obstruction; Rhinoplasty; Soft tissue biomechanics
• Additional Relevant MeSH Terms: Nervous System Diseases; Respiratory Tract Diseases; Apnea; Respiration Disorders; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Sleep Apnea Syndromes; Sleep Apnea, Obstructive
• Other Study ID Numbers: RCN303218

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: All IPD that underlie results in a publication
• IPD Sharing Time Frame: third quarter 2022 until the end of 2024
• IPD Sharing Access Criteria: links to all publications will be made available on the website
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; ICF; CSR

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No