Virtual Surgery of the Upper Airways-New Solutions to Obstructive Sleep Apnea Treatment
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 30
- 试验地点
- 2
- 主要终点
- Upper airway soft tissue characteristics
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •previous nasal or oropharyngeal surgery
- •previous use of nasal decongestant or nasal topical steroids over the last 3 months
结局指标
主要结局
Upper airway soft tissue characteristics
时间窗: Up to 3 months postoperatively
Specific descriptions of deformation and strain in soft tissues in sleep apnea patients
Change in Apnea-Hypopnea Index (AHI)
时间窗: Baseline and 3 months postoperatively
AHI is measured by sleep polygraphy in all patients before and after surgery
次要结局
未报告次要终点