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| Name | Class |
|---|---|
| SINTEF Health Research | OTHER |
| St. Olavs Hospital | OTHER |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Obstructive sleep apnea (OSA) | OSA patients who are eligible for either functional septorhinoplasty or oropharyngeal/orthognathic surgery |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| functional septorhinoplasty or oropharyngeal/orthognathic surgery | Procedure | obtain pre- and postoperative data in order to describe the specific changes in airflow and upper soft tissue behavior that causes sleep apnea |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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All eligible patients within the community of Mid-Norway referred to the sleep clinic from primary or secondary care facilities.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Mads HS Moxness, md phd | Contact | +47 99035515 | madsmox@gmail.com | |
| Ståle Nordgård, phd prof | Contact | 0047 72880232 | stale.nordgard@ntnu.no |
| Name | Affiliation | Role |
|---|---|---|
| Bjørn H Skallerud, phd prof | NTNU, Fac IV, Dept of Structural Engineering | Study Director |
| Ståle Nordgård, phd prof | NTNU, Fac MH, Dept of Neuromedicine and Movement Science | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| St Olavs Hospital | Recruiting | Trondheim | Trøndelag | 7006 | Norway |
All IPD that underlie results in a publication
third quarter 2022 until the end of 2024
links to all publications will be made available on the website
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| ID | Term |
|---|---|
| D020181 | Sleep Apnea, Obstructive |
| D015508 | Nasal Obstruction |
| ID | Term |
|---|---|
| D012891 | Sleep Apnea Syndromes |
| D001049 | Apnea |
| D012120 | Respiration Disorders |
| D012140 | Respiratory Tract Diseases |
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| ID | Term |
|---|---|
| D057909 | Orthognathic Surgery |
| ID | Term |
|---|---|
| D013515 | Surgery, Oral |
| D003813 | Dentistry |
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Soft tissue specimen from upper airways; soft palate and tonsils
| Bernhard Müller, phd prof | NTNU, Fac IV, Dept of Energy and Process Engineering | Principal Investigator |
| Sverre G Johnsen, phd | SINTEF Health Research | Principal Investigator |
| Ståle Nordgård, phd prof | St Olavs Hospital, Clinic Ear Nose and Throat | Study Director |
| Aleris Solsiden | Recruiting | Trondheim | Norway |
|
| D020919 |
| Sleep Disorders, Intrinsic |
| D020920 | Dyssomnias |
| D012893 | Sleep Wake Disorders |
| D009422 | Nervous System Diseases |
| D009668 | Nose Diseases |
| D000402 | Airway Obstruction |
| D012131 | Respiratory Insufficiency |
| D010038 | Otorhinolaryngologic Diseases |