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Virtual Surgery of the Upper Airways

NCT04829201 · Status: RECRUITING · Type: OBSERVATIONAL · Enrollment: 30

Last updated 2023-11-03

No results posted yet for this study

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.

Conditions

  • Sleep Apnea, Obstructive

Interventions

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

Sponsors & Collaborators

  • SINTEF Health Research

    collaborator OTHER

  • St. Olavs Hospital

    collaborator OTHER

  • Norwegian University of Science and Technology

    lead OTHER

Principal Investigators

  • Bjørn H Skallerud, phd prof · NTNU, Fac IV, Dept of Structural Engineering

  • Ståle Nordgård, phd prof · NTNU, Fac MH, Dept of Neuromedicine and Movement Science

  • Bernhard Müller, phd prof · NTNU, Fac IV, Dept of Energy and Process Engineering

  • Sverre G Johnsen, phd · SINTEF Health Research

  • Ståle Nordgård, phd prof · St Olavs Hospital, Clinic Ear Nose and Throat

Eligibility

Min Age
18 Years
Max Age
70 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-04-20
Primary Completion
2024-08-31
Completion
2024-12-31

Countries

  • Norway

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04829201 on ClinicalTrials.gov