Non-inferiority Analysis of Daytime Versus Overnight Polysomnography for Hypoglossal Nerve Stimulation Titration in Obstructive Sleep Apnea
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 110
- 试验地点
- 1
- 主要终点
- Non-inferiority of the delta apnea-hypopnea index (AHI) between the two cohorts as measured by a titration 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.
Approximately 3 months after activation of HNS therapy, a fine-tuning sleep study is performed. To date, the standard of care involves an in-laboratory overnight titration PSG, which assesses the device settings and, if necessary, the stimulation strength will be adjusted based on observed respiratory events and/or snoring. Considering the growing patient population, the performance of these overnight titrations can become logistically challenging and labor-intensive. Recently, the feasibility of using a daytime PSG as an alternative to a conventional overnight PSG for titration of HNS therapy was demonstrated.
The aim of this study is to further investigate this technique by performing a non-inferiority analysis of daytime versus overnight PSG for titration of HNS therapy in patients with OSA.
详细描述
This study is a prospective and retrospective, single-center non-inferiority study. The study population consists of two cohorts: (1) OSA patients treated with HNS that previously underwent an overnight titration PSG as part of the routine clinical care pathway and (2) OSA patients treated with HNS that recently underwent or will be undergoing a daytime titration PSG.
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 different visits including: pre-implant, implant, activation, titration, follow-up (6 and 12 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
- •Patients diagnosed with OSA and implanted with HNS therapy (Inspire system)
- •Cohort 1: Patients that previously underwent an overnight titration PSG as part of their routine clinical care at the Antwerp University Hospital
- •Cohort 2: Patients that recently underwent or will be undergoing a daytime titration PSG at the Antwerp University Hospital
- •Able to give informed consent
排除标准
- •Not able to understand the language of the questionnaires
结局指标
主要结局
Non-inferiority of the delta apnea-hypopnea index (AHI) between the two cohorts as measured by a titration polysomnography
时间窗: From baseline to the postoperative titration follow-up (approximately 3 months after activation of the therapy)
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
- Full-night AHI as measured during a titration polysomnography(At the postoperative titration follow-up (approximately 3 months after activation of the therapy))
- Percent 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 the postoperative titration follow-up (approximately 3 months after activation of the therapy) and 12 months follow-up)
- Percent of time spent in each sleep stage as measured during a titration polysomnography(At the postoperative titration follow-up (approximately 3 months after activation of the therapy))
- Percent of time spent in different body positions during a titration polysomnography(At the postoperative titration follow-up (approximately 3 months after activation of the therapy))
- Daytime sleepiness measured by the Epworth Sleepiness Scale (ESS) questionnaire(From baseline to the postoperative titration follow-up (approximately 3 months after activation of the therapy) and 12 months follow-up)
- Disease-specific quality of life as measured by the Functional Outcomes of Sleep Questionnaire-30 (FOSQ-30) questionnaire(From baseline to the postoperative titration follow-up (approximately 3 months after activation of the therapy) and 12 months follow-up)
- Treatment AHI as measured during a titration polysomnography(At the postoperative titration follow-up (approximately 3 months after activation of the therapy))
- Therapy adherence defined by the amount of hours therapy usage per night(At the postoperative titration follow-up (approximately 3 months after activation of the therapy) and 12 months follow-up)
- Delta sleep apnea specific hypoxic burden (SASHB) derived from a titration polysomnography(From baseline to the postoperative titration follow-up (approximately 3 months after activation of the therapy))
- Delta oxygen desaturation index (ODI) as measured by a polysomnography(From baseline to the postoperative titration follow-up (approximately 3 months after activation of the therapy) and 12 months follow-up)
- Degree of snoring measured by the Visual Analogue Scale (VAS) questionnaire(From baseline to the postoperative titration follow-up (approximately 3 months after activation of the therapy) and 12 months follow-up)