Assessment of the Effect of Hypoglossal Nerve Stimulation Therapy on the Site of Collapse During DISE
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 58
- 试验地点
- 2
- 主要终点
- Δ%area-of-collapse at the level of the lateral walls
研究概览
简要总结
The purpose of this study is to assess the site, pattern and degree of upper airway collapse before and during hypoglossal nerve stimulation (HNS) treatment using clinical standard drug-induced sleep endoscopy (DISE) and using a novel, non-invasive method predicting site of collapse from raw polysomnography (PSG) data.
Furthermore, outcomes will be compared between responders and non-responders.
详细描述
Patients who will receive hypoglossal nerve stimulation therapy will be recruited at the pre-operative consultation at the department of ENT. As part of the standard procedure, all patients who are eligible for HNS have already undergone DISE.
To be included in the study, the patient should have undergone or is scheduled to undergo a baseline PSG within two years of HNS implantation.
All patients will undergo HNS-implantation and receive HNS-therapy as part of the standard pathway.
One year after HNS-therapy, patients will undergo another PSG as part of routine practice in these patients. An additional DISE will be performed to assess the effect of HNS on the site, pattern and degree of upper airway collapse.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Basic Science
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •18 years or older.
- •Eligible for HNS-therapy:
- •AHI between 15 and 65 events/hour
- •BMI under 32 kg/m2
- •Absence of complete concentric collapse of palate (CCC) on DISE
- •Intolerance or failure of continuous positive airway pressure (CPAP)-treatment
- •Intolerance or failure of mandibular advancement device (MAD)-treatment
- •Combination of central and mixed apneas less than 25% of total apneas on recent PSG (not older than two years)
- •Scheduled for HNS-implantation at the Antwerp University Hospital
- •Capable of giving informed consent
- •Baseline polysomnography planned or performed in the last 2 years at the Antwerp University Hospital
排除标准
- •Patients will not receive HNS-therapy at the Antwerp University Hospital
- •Known medical history of intellectual disability, memory disorders or current psychiatric disorders (psychotic illness, major depression, or acute anxiety attacks as mentioned by the patient).
结局指标
主要结局
Δ%area-of-collapse at the level of the lateral walls
时间窗: Between baseline and one year follow-up
The percentage of the area of collapse at the level of the lateral walls - measured using DISE - will be calculated using ImageJ software. The percentage difference of collapse between baseline and one-year follow-up will be calculated.
次要结局
- Non-invasive site and pattern of collapse(At baseline and at one-year follow-up)
- Δ%area-of-collapse at the level of the palate, tongue base and epiglottis(Between baseline and one year follow-up)
- Δ%area-of-collapse at each possible site of upper airway collapse (palate, lateral walls, tongue base, epiglottis) in responders and non-responders(Between baseline and one year follow-up)
- DISE-score during baseline DISE and during one-year follow-up DISE.(At baseline and at one-year follow-up)