Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
30 participants
OBSERVATIONAL
2021-04-20
2024-12-31
Brief Summary
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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.
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Detailed Description
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WP 2, 3 and 4 deals with the mathematical modeling, structural mechanic modeling and the patient-specific airflow modeling.
Conditions
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Study Design
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CASE_ONLY
PROSPECTIVE
Study Groups
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Obstructive sleep apnea (OSA)
OSA patients who are eligible for either functional septorhinoplasty or oropharyngeal/orthognathic surgery
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
Interventions
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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
Eligibility Criteria
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Inclusion Criteria
* 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 use of nasal decongestant or nasal topical steroids over the last 3 months
18 Years
70 Years
ALL
No
Sponsors
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SINTEF Health Research
OTHER
St. Olavs Hospital
OTHER
Norwegian University of Science and Technology
OTHER
Responsible Party
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Principal Investigators
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Bjørn H Skallerud, phd prof
Role: STUDY_DIRECTOR
NTNU, Fac IV, Dept of Structural Engineering
Ståle Nordgård, phd prof
Role: PRINCIPAL_INVESTIGATOR
NTNU, Fac MH, Dept of Neuromedicine and Movement Science
Bernhard Müller, phd prof
Role: PRINCIPAL_INVESTIGATOR
NTNU, Fac IV, Dept of Energy and Process Engineering
Sverre G Johnsen, phd
Role: PRINCIPAL_INVESTIGATOR
SINTEF Health Research
Ståle Nordgård, phd prof
Role: STUDY_DIRECTOR
St Olavs Hospital, Clinic Ear Nose and Throat
Locations
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St Olavs Hospital
Trondheim, Trøndelag, Norway
Aleris Solsiden
Trondheim, , Norway
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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RCN303218
Identifier Type: -
Identifier Source: org_study_id
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