Comparison Between Natural Sleep Endoscopy and Drug-induced Sleep Endoscopy in Patients With Obstructive Sleep Apnea
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 40
- 试验地点
- 2
- 主要终点
- Endoscopic Classification System
研究概览
简要总结
Drug-induced sleep endoscopy (DISE) is the most used technique for identifying the obstruction site associated with obstructive sleep apnea (OSA). This is due to the fact that it allows many patients to be examined in a daytime setting. This procedure uses sedative drugs to mimic natural sleep. However, associations with the site of upper airway (UA) collapse during natural sleep remain unclear.
The aim of this explorative study is to identify UA collapse in patients with OSA using endoscopic techniques as well as flow shape characteristics and sound analyses during natural and drug-induced sleep. Furthermore, we want to optimize the measurement set-up of natural sleep endoscopy (NSE).
详细描述
Patients with moderate to severe OSA requiring DISE will be recruited for this prospective study at the outpatient clinic. Patients will undergo a NSE at the sleep lab at night, and a DISE at the operating theatre within three months. Both the NSE and DISE set-up will include gold-standard flow measurements, acoustic analysis and esophageal pressure measurements.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Single Group
- 主要目的
- Diagnostic
- 盲法
- Single (Outcomes Assessor)
盲法说明
NSE and DISE will be performed by two separate researchers, blinding the ENT surgeon who performs the NSE or DISE for the outcome of the other procedure. This is a blinded study and the researchers will have no knowledge of the patient's characteristics / demographic variables and their history.
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
- •Diagnosis of OSA with a baseline AHI ≥ 15 per hour based on full polysomnography
- •Body mass index (BMI) ≤ 35 kg/m²
- •Capability of giving informed consent and willingness to undergo NSE
排除标准
- •Central sleep apnea (defined as CAHI ≥ 30% of total AHI)
- •Inability to sleep in a supine position due to a medical condition
- •Inability of the patient to understand and/or comply to the study procedures
- •Neuromuscular disorders or craniofacial anomalies affecting the UA
- •Sedative medication use (opioids and muscle relaxants)
- •Active psychiatric disorders (psychotic illness, major depression, anxiety attacks, excessive alcohol or drug use)
- •Severe or decompensated cardiac or respiratory diseases
- •Medical history of known causes of tiredness by day or severe sleep disruption (insomnia, PLMS, narcolepsy)
- •Contra-indications for DISE: i.e. fitness for general anesthesia (ASA>3), allergy to sedative agent(s) and an expected extremely difficult airway
- •Pregnancy or willing to become pregnant
结局指标
主要结局
Endoscopic Classification System
时间窗: Immediately, during the procedure
Comparison of the frequencies of the site, gradation and pattern of upper airway collapse between natural and drug-induced sleep endoscopy.
次要结局
- Acoustic analysis(Immediately, during the procedure)
- Flow shape analysis(Immediately, during the procedure)
研究者
ethisch.comite@uza.be
Olivier Vanderveken, Professor and Chair Otorhinolaryngology
University Hospital, Antwerp