Measurement of Critical Closing Pressure (Pcrit) During Drug-Induced Sleep Endoscopy (DISE)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 13
- 试验地点
- 1
- 主要终点
- Critical closing pressure of the upper airway (Pcrit)
研究概览
简要总结
This study intends to test the feasibility of measurement of the critical closing pressure (Pcrit) during drug-induced sleep endoscopy (DISE) for use in future studies, which are aimed at finding an alternative method for patient selection and response prediction before implementation of non-CPAP therapies.Twenty patients diagnosed with OSA and eligible for non-CPAP treatments are going to be included into this study and undergo these measurements. Drug-induced sleep endoscopy (DISE) is part of the standard clinical care for OSA patients that are eligible for non-CPAP therapies. We aim to expand this procedure with measurement of Pcrit, oesophageal pressure, airflow, EEG, EOG, respiratory effort, SpO2 and chin EMG during this study.
详细描述
Patients from the ENT department will be recruited and informed about the study. After obtaining informed consent, the patients will undergo DISE according to the normal clinical care.The study will be performed during this clinical DISE, using a standard polysomnographic set-up (Alice 6 LDx, Philips Respironics) expanded with pressure and flow measurements. After measurements and evaluations are done, the most suitable treatment option based on the DISE and PSG findings, as defined in the standard clinical care, will be advised to the patient. The treatment and its further choice are not part of the current study protocol.
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
- 否
入选标准
- •18 years or older
- •Diagnosis with OSA (AHI ≥15/hour sleep)
- •Eligible for DISE as the next step in the clinical path for OSA.
- •Capable of giving informed consent
排除标准
- •Medication use related to sleeping disorders.
- •Central sleep apnea syndrome.
- •Medical history of known causes of tiredness or severe sleep disruption other than OSA (insomnia, PLMS, Narcolepsy).
- •Seizure disorder.
- •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).
- •Inability to provide informed consent.
- •Simultaneous use of other treatment modalities to treat OSA
- •Esophageal ulceration, tumors, diverticulitis, bleeding varices, sinusitis, epistaxis, recent nasopharyngeal surgery
- •Pregnancy or willing to become pregnant
- •Excessive alcohol or drug use (> 20 alcohol units/week or any use of hard drugs)
结局指标
主要结局
Critical closing pressure of the upper airway (Pcrit)
时间窗: 1 hour
The pressure at which the upper airway collpases measured in cm H2O.
次要结局
- Esophageal pressure(1 hour)
- Airflow(1 hour)
- EEG(1 hour)
- SpO2(1 hour)
- EOG(1 hour)
- EMG(1 hour)
研究者
ethisch.comite@uza.be
Prof. Dr. Olivier Vanderveken
University Hospital, Antwerp