NCT06578390招募中不适用
Efficacy Investigation of the Medical Device Apneal® on Smartphone for Sleep Apnea-Hypopnea Syndrome Diagnosis
Mitral22 个研究点 分布在 1 个国家目标入组 500 人开始时间: 2024年3月26日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 500
- 试验地点
- 22
- 主要终点
- Evaluate the performance of Apneal® in diagnosing sleep apnea-hypopnea syndrome (SAHS)
研究概览
简要总结
The goal of this clinical trial is to evaluate the effectiveness of the Apneal® app in diagnosing sleep apnea syndrome (SAS) in adults who require polysomnography (PSG) as part of routine care. The main questions it aims to answer are:
- Can Apneal® accurately classify the SAS severity into four categories (normal: AHI < 5, mild: 5 ≤ AHI < 15, moderate: 15 ≤ AHI < 30, and severe: AHI ≥ 30) compared to PSG ?
- How does Apneal® perform in estimating the Apnea-Hypopnea Index (AHI), detecting sleep stages, differentiating between central and obstructive apneas, and identifying patient movements?
Participants will:
- Wear the Apneal® app-equipped smartphone and undergo PSG during a full night of sleep at home.
- Complete several questionnaires assessing sleep symptoms and experience with the Apneal® app.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Diagnostic
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Individuals, male or female, aged 18 years or older (no upper age limit).
- •Individuals for whom polysomnography (PSG) is indicated as part of routine care, regardless of the specific indication.
- •Individuals with a reported total sleep time of at least 6 hours, in accordance with AASM recommendations for PSG analysis.
- •Individuals affiliated with social security or benefiting from a similar system, if applicable, in accordance with local regulations.
- •Voluntary individuals who have provided oral and written consent after being informed by the research investigator.
排除标准
- •Individuals with an active implantable medical device (e.g., electronic cardiac implant, neurophysiological electrical stimulator).
- •Individuals with a chest deformity that prevents proper placement of the smartphone on the chest.
- •Individuals with uncontrolled psychiatric disorders that prevent them from giving full consent to the study.
- •Individuals unable to understand or speak the official language of the research center.
- •Individuals currently excluded from another protocol or participating in another interventional research study.
- •Vulnerable persons or adults under legal protection, including pregnant or breastfeeding women, persons deprived of liberty by judicial or administrative decision, individuals hospitalized without consent, or admitted for purposes other than research (Articles L1121-5 to L1121-8 of the French Public Health Code).
结局指标
主要结局
Evaluate the performance of Apneal® in diagnosing sleep apnea-hypopnea syndrome (SAHS)
时间窗: through study completion, an average of 1 year
Performance of Apneal® in classifying the severity of SAHS into four categories (normal: AHI \< 5, mild: 5 ≤ AHI \< 15, moderate: 15 ≤ AHI \< 30, severe: AHI ≥ 30) compared to polysomnography (PSG).
次要结局
- Estimate the Apnea-Hypopnea Index (AHI) using Apneal®(through study completion, an average of 1 year)
- Compare Apneal® with screening questionnaires (NoSAS, Berlin, Epworth)(through study completion, an average of 1 year)
- Differentiate central and obstructive apneas using Apneal®(through study completion, an average of 1 year)
- Evaluate patient acceptability of Apneal®(through study completion, an average of 1 year)
- Detect sleep stages using Apneal®(through study completion, an average of 1 year)
- Assess the feasibility of SAHS screening using Apneal®(through study completion, an average of 1 year)
- Detect patient movements with Apneal®(through study completion, an average of 1 year)
研究者
研究点 (22)
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