VirtuOSA: Virtual Surgery of the Upper Airways

• Sponsor: Norwegian University of Science and Technology (Other)
• Overall Status: Recruiting
• CT.gov ID: NCT04829201
• Collaborator: SINTEF Health Research (Other), St. Olavs Hospital (Other)
• Enrollment: 30
• Locations: 2
• Anticipated Duration (Months): 44.4
• Patients Per Site: 15
• Patients Per Site Per Month: 0.3

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Sleep Apnea, Obstructive	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 Design

• Study Type: Observational
• Anticipated Enrollment: 30 participants
• Observational Model: Case-Only
• Time Perspective: Prospective
• Official Title: Virtual Surgery of the Upper Airways-New Solutions to Obstructive Sleep Apnea Treatment
• Actual Study Start Date: Apr 20, 2021
• Anticipated Primary Completion Date: Aug 31, 2024
• Anticipated Study Completion Date: Dec 31, 2024

Arms and Interventions

Arm	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

Outcome Measures

Primary Outcome Measures

1. Change in Apnea-Hypopnea Index (AHI) [Baseline and 3 months postoperatively]

   AHI is measured by sleep polygraphy in all patients before and after surgery

2. Upper airway soft tissue characteristics [Up to 3 months postoperatively]

   Specific descriptions of deformation and strain in soft tissues in sleep apnea patients

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 70 Years
• Sexes Eligible for Study: All
• Accepts 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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	St Olavs Hospital	Trondheim	Trøndelag	Norway	7006
2	Aleris Solsiden	Trondheim		Norway

Sponsors and Collaborators

• Norwegian University of Science and Technology
• SINTEF Health Research
• St. Olavs Hospital

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 Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Norwegian University of Science and Technology
• ClinicalTrials.gov Identifier: NCT04829201
• Other Study ID Numbers: RCN303218
• First Posted: Apr 2, 2021
• Last Update Posted: Oct 4, 2021
• Last Verified: Sep 1, 2021

• Individual Participant Data (IPD) Sharing Statement: Yes
• Plan to Share IPD: Yes
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by Norwegian University of Science and Technology: Surgery; Rhinoplasty; Nasal Obstruction; Soft tissue biomechanics
• Additional relevant MeSH terms: Sleep Apnea Syndromes; Sleep Apnea, Obstructive

Study Results

No Results Posted as of Oct 4, 2021