Automated Versus Manual Polysomnographic Scoring in Adult Patients With Obstructive Sleep Apnea: A Prospective Comparative Study
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- Apnea-Hypopnea Index (AHI) Agreement
研究概览
简要总结
This prospective study aims to compare automated polysomnographic scoring with manual scoring in adult patients with Obstructive Sleep Apnea (OSA). The main objective is to evaluate the accuracy, reliability, and time efficiency of automated scoring algorithms compared to standard manual scoring performed by expert sleep specialists
详细描述
Study Procedures
- Pre-PSG Assessment: Demographic data, anthropometric measurements (weight, height, Body mass index (BMI), neck circumference), vital signs, comorbidities, and the STOP-BANG questionnaire are recorded.
- Overnight PSG: Conducted in a sound-attenuated, temperaturecontrolled, well-prepared sleep lab using either SOMNOscreen plus (SOMNOmedics GmbH) or Alice® 6 Sleepware (Philips Respironics, PA,
USA). Both systems acquire this channels montage:
• EEG (six channels: F3, F4, C3, C4, O1, O2 referenced to ipsilateral mastoids)
• EOG (two channels: left and right outer canthus)
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
- •Age > 18 years. • Clinical suspicion of OSA based on history, physical examination, and a positive screening questionnaire (e.g., STOP-BANG ≥ 3).
- •Ability to provide written informed consent.
排除标准
- •Age ≤ 18 years. • Inability to give informed consent (e.g., severe cognitive impairment, language barrier). • Contraindications to PSG (e.g., severe skin conditions preventing electrode placement).
- •Current use of therapies that could alter sleep architecture (e.g., highdose benzodiazepines, opioids) unless a wash-out period is observed.
研究组 & 干预措施
Adult OSA Patients
Adult patients diagnosed with Obstructive Sleep Apnea undergoing polysomnography to compare automated versus manual scoring.
干预措施: Polysomnographic Scoring (Automated vs. Manual) (Diagnostic Test)
结局指标
主要结局
Apnea-Hypopnea Index (AHI) Agreement
时间窗: At the time of sleep study completion (1 night)
Comparison of the Apnea-Hypopnea Index (AHI) values obtained from automated polysomnographic scoring against those obtained from manual scoring.
次要结局
未报告次要终点