Virtual surgery for treating obstructive sleep apnea
Virtual Surgery of the Upper Airways-New Solutions to Obstructive Sleep Apnea Treatment
This study is testing how virtual surgery can help people with obstructive sleep apnea by looking at their airway function before and after they have surgery to improve breathing.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 30 (estimated) |
| Ages | 18 Years to 70 Years |
| Sex | All |
| Sponsor | Norwegian University of Science and Technology Academic / other |
| Locations | 2 sites (Trondheim, Trøndelag and 1 other locations) |
| Trial ID | NCT04829201 on ClinicalTrials.gov |
What this trial studies
This observational study focuses on patients with obstructive sleep apnea (OSA) who require surgical intervention to improve airway patency. It aims to include up to 30 patients undergoing functional septorhinoplasty or oropharyngeal/orthognathic surgery, with detailed assessments of nasal airflow and pressure, as well as ConeBeam CT scans of the upper airways before and after surgery. The study is part of a larger project that utilizes mathematical and computational modeling to enhance understanding of airway function and develop software tools for better diagnostics and treatment of OSA.
Who should consider this trial
Good fit: Ideal candidates are individuals diagnosed with obstructive sleep apnea who require surgical procedures to address nasal or oropharyngeal obstruction.
Not a fit: Patients who have previously undergone nasal or oropharyngeal surgery or have used nasal decongestants or topical steroids in the last three months may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to more effective, patient-specific surgical options for individuals suffering from obstructive sleep apnea.
How similar studies have performed: While the approach of using computational modeling in this context is innovative, similar studies have shown promise in improving surgical outcomes for sleep apnea.
Eligibility criteria
Show full inclusion / exclusion criteria
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
Where this trial is running
Trondheim, Trøndelag and 1 other locations
- St Olavs Hospital — Trondheim, Trøndelag, Norway (Recruiting)
- Aleris Solsiden — Trondheim, Norway (Recruiting)
Study contacts
- Principal investigator: Ståle Nordgård, phd prof — NTNU, Fac MH, Dept of Neuromedicine and Movement Science
- Study coordinator: Mads HS Moxness, md phd
- Email: madsmox@gmail.com
- Phone: +47 99035515
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.