Virtual Surgery of the Upper Airways

Recruiting

• Conditions: Sleep Apnea, Obstructive
• Interventions: Procedure: functional septorhinoplasty or oropharyngeal/orthognathic surgery

• Registration Number: NCT04829201
• Lead Sponsor: Norwegian University of Science and Technology

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 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 Timeline

• Study First Submitted: 2021-02-08
• Study First Submitted QC: 2021-03-31
• Study First Posted: 2021-04-02
• Study Start: 2021-04-20
• Status Verified: 2023-11
• Last Update Submitted: 2023-11-02
• Last Update Posted: 2023-11-03
• Primary Completion: 2024-08-31
• Study Completion: 2024-12-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 30

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Obstructive sleep apnea (OSA)	functional septorhinoplasty or oropharyngeal/orthognathic surgery	OSA patients who are eligible for either functional septorhinoplasty or oropharyngeal/orthognathic surgery

Primary Outcome Measures

Name	Time	Method
Upper airway soft tissue characteristics	Up to 3 months postoperatively	Specific descriptions of deformation and strain in soft tissues in sleep apnea patients
Change in Apnea-Hypopnea Index (AHI)	Baseline and 3 months postoperatively	AHI is measured by sleep polygraphy in all patients before and after surgery

Trial Locations

Locations (2)

St Olavs Hospital; 🇳🇴 Trondheim, Trøndelag, Norway

Aleris Solsiden; 🇳🇴 Trondheim, Norway