Sleep Apnea, ObstructiveVirtuOSANCT04829201
Virtual Surgery of the Upper Airways
An observational study of Sleep Apnea, Obstructive, run by Norwegian University of Science and Technology at 2 sites in Norway.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Sleep Apnea, Obstructive
- What is being tested?
- functional septorhinoplasty or oropharyngeal/orthognathic surgery
- Type of treatment
- Surgery or procedure
- How many people
- 30 participants
- Where
- 2 sitesNorway
- Study dates
- 20 Apr 2021to 31 Dec 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: All eligible patients within the community of Mid-Norway referred to the sleep clinic from primary or secondary care facilities.
Who may be able to join
- 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.
Who cannot join
- previous nasal or oropharyngeal surgery
- previous use of nasal decongestant or nasal topical steroids over the last 3 months
Trial locations and contacts
2 sites in 1 country.
Norway2 sites
St Olavs Hospital
Trondheim, Trøndelag, 7006
Aleris Solsiden
Trondheim
About this study
Official title: Virtual Surgery of the Upper Airways-New Solutions to Obstructive Sleep Apnea Treatment
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.
Read more
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.
Read the 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 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.
- Conditions
- Sleep Apnea, Obstructive
- Being tested
- functional septorhinoplasty or oropharyngeal/orthognathic surgery
- Keywords
- Surgery, Rhinoplasty, Nasal Obstruction, Soft tissue biomechanics
- Medical subject headings
- Sleep Apnea, Obstructive, Nasal Obstruction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
functional septorhinoplasty or oropharyngeal/orthognathic surgeryProcedure or surgery
obtain pre- and postoperative data in order to describe the specific changes in airflow and upper soft tissue behavior that causes sleep apnea
| Study group | Role | What they receive |
|---|---|---|
| Obstructive sleep apnea (OSA) | OSA patients who are eligible for either functional septorhinoplasty or oropharyngeal/orthognathic surgery Receives: Procedure: functional septorhinoplasty or oropharyngeal/orthognathic surgery |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Apnea-Hypopnea Index (AHI)
AHI is measured by sleep polygraphy in all patients before and after surgery
Measured: Baseline and 3 months postoperatively
Upper airway soft tissue characteristics
Specific descriptions of deformation and strain in soft tissues in sleep apnea patients
Measured: Up to 3 months postoperatively
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Apr 2021
- Study start20 Apr 2021
- Primary completion31 Aug 2024
- Study completion31 Dec 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Sleep Apnea, ObstructiveStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Norwegian University of Science and Technology
- Sponsor type
- University, hospital or other
- Collaborators
- SINTEF Health Research, St. Olavs Hospital
- Responsible party
- Sponsor
- Investigators
- Bjørn H Skallerud, phd prof, Study director, NTNU, Fac IV, Dept of Structural EngineeringStåle Nordgård, phd prof, Principal investigator, NTNU, Fac MH, Dept of Neuromedicine and Movement ScienceBernhard Müller, phd prof, Principal investigator, NTNU, Fac IV, Dept of Energy and Process EngineeringSverre G Johnsen, phd, Principal investigator, SINTEF Health ResearchStåle Nordgård, phd prof, Study director, St Olavs Hospital, Clinic Ear Nose and Throat
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04829201
- Sponsor's protocol ID
- RCN303218
- Acronym
- VirtuOSA
- Status last verified
- Oct 2026
- First submitted
- 8 Feb 2021
- Last updated
- 16 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: All IPD that underlie results in a publication
Study at a glance
From the registry record, last updated by the sponsor on 16 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Virtual Surgery of the Upper Airways-New Solutions to Obstructive Sleep Apnea Treatment
- ClinicalTrials.gov ID
- NCT04829201
- Acronym / sponsor ID
- VirtuOSA / RCN303218
- Conditions
- Sleep Apnea, Obstructive
- Keywords
- Surgery, Rhinoplasty, Nasal Obstruction, Soft tissue biomechanics
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Norwegian University of Science and TechnologyUniversity, hospital or other
- Collaborators
- SINTEF Health Research, St. Olavs Hospital
- Study start
- 20 Apr 2021 (actual)
- Primary completion
- 31 Aug 2024 (actual)
- Study completion
- 31 Dec 2024 (actual)
- First posted
- 2 Apr 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 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.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Obstructive sleep apnea (OSA) | – | Procedure: functional septorhinoplasty or oropharyngeal/orthognathic surgeryOSA patients who are eligible for either functional septorhinoplasty or oropharyngeal/orthognathic surgery |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- All eligible patients within the community of Mid-Norway referred to the sleep clinic from primary or secondary care facilities.
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (2 listed)
- previous nasal or oropharyngeal surgery
- previous use of nasal decongestant or nasal topical steroids over the last 3 months
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| functional septorhinoplasty or oropharyngeal/orthognathic surgeryobtain pre- and postoperative data in order to describe the specific changes in airflow and upper soft tissue behavior that causes sleep apnea | Procedure or surgery | Obstructive sleep apnea (OSA) |
Primary outcome
Change in Apnea-Hypopnea Index (AHI)
Time frame: Baseline and 3 months postoperatively
AHI is measured by sleep polygraphy in all patients before and after surgery
Upper airway soft tissue characteristics
Time frame: Up to 3 months postoperatively
Specific descriptions of deformation and strain in soft tissues in sleep apnea patients
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Oct 2026.
- Individual participant dataSharing planned: Yes. All IPD that underlie results in a publication
Related trials for Sleep Apnea, Obstructive
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Bjørn H Skallerud, phd prof study director
NTNU, Fac IV, Dept of Structural Engineering
Ståle Nordgård, phd prof principal investigator
NTNU, Fac MH, Dept of Neuromedicine and Movement Science
Bernhard Müller, phd prof principal investigator
NTNU, Fac IV, Dept of Energy and Process Engineering
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Sleep Apnea, Obstructive, run by Norwegian University of Science and Technology at 2 sites in Norway.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 16 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Norway. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Apnea-Hypopnea Index (AHI) (time frame: Baseline and 3 months postoperatively). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Oct 2026.