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临床试验/NCT06154577
NCT06154577已完成不适用

Tongue Morphology and Posterior Airway Space as Predictors of Response in Patientswith Hypoglossal Nerve Stimulation Therapy

Cantonal Hosptal, Baselland2 个研究点 分布在 1 个国家目标入组 65 人开始时间: 2023年5月15日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
65
试验地点
2
主要终点
Prediction of therapeutic success with hypoglossal nerve stimulation

研究概览

简要总结

Hypoglossal nerve stimulation (HNS) plays an increasingly important role in managing patients with obstructive sleep apnea (OSA) who do not tolerate CPAP therapy and are not eligible for other alternative treatment options, such as mandibular advancement devices or positional therapy. The posterior upper airway space dimensions are crucial in managing patients with HNS in the patient selection process and therapy control. The lateral collapse of the upper airway is of crucial importance. Lateral collapse at the palatal level and of the oropharyngeal walls is a well-established negative predictive factor for therapeutic success. Patients with complete concentric collapse at the palatal level (pCCC) in drug-induced sedation endoscopy (DISE) must be excluded from the implantation of HNS, which is cumbersome and invasive. Endoscopy has the inherent limitation that only one level can be observed at a given time, and assessment is possibly hampered by phlegm.

During activation and titration of HNS, tongue protrusion is observed in the awake patient. However, this method does not allow for assessing the opening of the retroglossal (RG) and retropalatal (RP) airway space, which is the ultimate therapeutic goal. Insufficient opening of the airway is the reason for non-responders with HNS. Insufficient upper airway opening can be either at the retropalatal or retroglossal level. The study aims to identify insufficient airway openings better using sub-mental ultrasonography. Sub-mental standardized and orientated ultrasonography offers a quantitative, reproducible way of assessing transverse upper airway dimensions and anatomic features of the upper airway in a rapid and non-invasive manner. In addition, anatomic characteristics of the airway's adjacent tissue, such as the size and shape of the tongue, may also have an impact on the effectiveness of HNS. Tongue morphology and posterior airway space assessment could be used in preoperative evaluation and during therapeutic titration of HNS. The clinical routine could be included tongue morphology and posterior airway space assessment without additional patient risks. However, the clinical value of assessing posterior airway space and tongue morphology in patients with HNS is yet unknown.

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 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Patients older than 18 year
  • patients with a hypoglossal nerve implantation
  • control group: 15 subjects without OSA (AHI<10/h)
  • written informed consent
  • sufficient knowledge of German or French to understand informed consent

排除标准

  • Patients younger than 18 years
  • unwillingness to give informed consent
  • incapable of performing Müller's maneuver
  • history of head and neck surgery other than HNS, tonsillectomy, and maxillomandibular advancement
  • diagnosis of congestive heart failure or chronic pulmonary disease
  • diagnosis of co-morbid sleep disorders, including central sleep apnea
  • pregnancy

结局指标

主要结局

Prediction of therapeutic success with hypoglossal nerve stimulation

时间窗: Most recent sleep testing before examination after HNS implantation, a maximum of 6 months before examination

Success is defined as apnea-hypopnea index in the most recent sleep testing ≤ 20/h and 50% reduction from baseline

次要结局

  • Prediction of AHI reduction, defined as the difference between pre- and postoperative AHI, with HNS based on tongue morphology and posterior airway space.(Most recent sleep testing before examination after HNS implantation, a maximum of 6 months before examination)
  • Information gain through from tongue morphology and posterior airway space imaging(through study completion, from 15.05.2023 to 14.05.2024)
  • Comparison of pharyngeal dimensions between visual assessment and tongue morphology and posterior airway space(through study completion, from 15.05.2023 to 14.05.2024)
  • Therapeutical guidance using tongue morphology and posterior airway space to identify the obstructing upper airway segment compared to wake fiberoptic endoscopy during HGS in non-responders.(through study completion, from 15.05.2023 to 14.05.2024)
  • Patient comfort rated by the patients for wake transnasal endoscopy and sub-mental ultrasonography(through study completion, from 15.05.2023 to 14.05.2024)
  • Comparison of pharyngeal dimensions of healthy and patients with OSA and HNS(through study completion, from 15.05.2023 to 14.05.2024)

研究者

发起方
Cantonal Hosptal, Baselland
申办方类型
Other
责任方
Sponsor

研究点 (2)

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