Hypoglossal Nerve Stimulation (HNS) Therapy in Patients With Obstructive Sleep Apnea (OSA): Belgian Registry
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 225
- 试验地点
- 2
- 主要终点
- Delta apnea-hypopnea index (AHI) as measured by a polysomnography
研究概览
简要总结
Hypoglossal nerve stimulation (HNS) therapy (Inspire system) is intended for the treatment of patients with moderate to severe obstructive sleep apnea (OSA) who cannot be effectively treated with the first-line treatment options. Recently, the request for reimbursement of the Inspire system in Belgium was approved.
The aim is to create a multi-center registry of OSA patients that are treated with HNS (Inspire system) within routine clinical care in Belgium.
详细描述
Patients that are implanted with the Inspire system in Belgium will be invited to participate in the registry. Data will be collected from different routine clinical care visits over a period of 5 years post-implantation. All assessments of the registry are part of the standard clinical care. Data collection will include polysomnographic data, home sleep test data, therapy usage, device data and questionnaires (Epworth Sleepiness Scale, Functional Outcomes of Sleep Questionnaire-30, Visual Analogue Scale (VAS) snoring.
Data will be collected from routine visits including: pre-implant, implant, activation, titration, follow-up (6, 12, 24, 36, 48 and 60 months post-implantation).
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 99 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Any patient implanted with or receiving the Inspire HNS system and who is able to give informed consent is eligible to participate in the registry. A patient is eligible for HNS implantation if he/she meets the following criteria:
- •At least 18 years old at the time of implantation
- •The patient suffers from moderate to severe OSA (15 events/h ≤ AHI ≤ 65 events/h)
- •The patient has failed, not tolerated or has a contraindication for continuous positive airway pressure (CPAP) and/or mandibular advancement device (MAD) therapy
- •Absence of complete concentric collapse of the level of the soft palate during Drug-Induced Sleep Endoscopy (DISE)
排除标准
- •Body mass index (BMI) >32 kg/m².
- •Combined mixed and central AHI is more than 25% of the total AHI
- •Patients with complete concentric collapse at the level of the soft palate or any other anatomical deviation that could impede the proper functioning of HNS
- •Patients with severely impaired neurological control over the upper airway
- •Pregnancy
- •Surgery performed on the soft palate in the past three months before implantation.
结局指标
主要结局
Delta apnea-hypopnea index (AHI) as measured by a polysomnography
时间窗: From baseline to 6, 12 and 60 months post-implantation
The AHI is an index of sleep apnea severity that encompasses the frequency of apneas (cessations in breathing) and hypopneas (reductions in airflow) per hour of sleep.
次要结局
- % of patients that reach treatment success defined by a 50% reduction in AHI and an on therapy AHI of < 20 events/h OR an on therapy AHI of < 15 events/h(At 6, 12 and 60 months post-implantation)
- Therapy adherence defined by the amount of hours therapy usage per night.(At 6, 12 and 60 months post-implantation)
- Delta oxygen desaturation index (ODI) as measured by a polysomnography(From baseline to 6, 12 and 60 months post-implantation)
- Pathophysiological endotypes(At 6, 12 and 60 months post-implantation)
- New OSA severity metrics(At 6, 12 and 60 months post-implantation)
- Daytime sleepiness measured by the Epworth Sleepiness Scale (ESS) questionnaire(From baseline to 6, 12 and 60 months post-implantation)
- Disease-specific quality of life as measured by the Functional Outcomes of Sleep Questionnaire-30 (FOSQ-30) questionnaire(From baseline to 6, 12 and 60 months post-implantation)
- Degree of snoring measured by the Visual Analogue Scale (VAS) questionnaire(From baseline to 6, 12 and 60 months post-implantation)
- Flow-derived site of collapse(At 6, 12 and 60 months post-implantation)