Ignite Creation Date:
2024-05-06 @ 3:59 PM
Last Modification Date:
2024-10-26 @ 2:01 PM
Study NCT ID:
NCT04829201
Status:
RECRUITING
Last Update Posted:
2023-11-03
First Post:
2021-02-08
Brief Title:
Virtual Surgery of the Upper Airways
Sponsor:
Norwegian University of Science and Technology
Organization:
Norwegian University of Science and Technology
Study Overview
Official Title:
Virtual Surgery of the Upper Airways-New Solutions to Obstructive Sleep Apnea Treatment
Status:
RECRUITING
Status Verified Date:
2023-11
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
VirtuOSA
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
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
WP 2 3 and 4 deals with the mathematical modeling structural mechanic modeling and the patient-specific airflow modeling
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None