Status:
UNKNOWN
Virtual Surgery of the Upper Airways
Lead Sponsor:
Norwegian University of Science and Technology
Collaborating Sponsors:
SINTEF Health Research
St. Olavs Hospital
Conditions:
Sleep Apnea, Obstructive
Eligibility:
All Genders
18-70 years
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...
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 b...
Eligibility Criteria
Inclusion
- 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
- previous nasal or oropharyngeal surgery
- previous use of nasal decongestant or nasal topical steroids over the last 3 months
Key Trial Info
Start Date :
April 20 2021
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
December 31 2024
Estimated Enrollment :
30 Patients enrolled
Trial Details
Trial ID
NCT04829201
Start Date
April 20 2021
End Date
December 31 2024
Last Update
November 3 2023
Active Locations (2)
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1
St Olavs Hospital
Trondheim, Trøndelag, Norway, 7006
2
Aleris Solsiden
Trondheim, Norway