NCT06474143已完成不适用
Evaluation of the Clinical Performance of Apneal®, a Medical Device on Smartphone, for Sleep Apnea-hypopnea Syndrome Diagnosis studY
Institut National de la Santé Et de la Recherche Médicale, France1 个研究点 分布在 1 个国家目标入组 491 人开始时间: 2024年2月28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
- 491
- 试验地点
- 1
- 主要终点
- Performance of Apneal® in categorizing SAHS severity using AHI
研究概览
简要总结
The goal of this clinical trial is to test the ability of the Apneal application in diagnosing sleep apnea in adult patients.
Participants will be asked to wear the Apneal device during their fulll-night sleep test (polysomnography, the gold standard for sleep apnea)
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
盲法说明
Polysomnography results not available to device
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
- •Individuals, men or women, aged over 18 and with no upper age limit;
- •Individuals for whom PSG is indicated as part of routine care, regardless of indication.
- •Individuals willing and able to comply with study requirements;
- •Individuals with a declared total sleep time of at least 6 hours, as recommended by AASM for PSG analysis.
- •Individuals affiliated to social security or beneficiary of such a scheme if applicable according to the local regulation ;
- •Voluntary individuals who have provided oral and written consent after being informed by the research investigator.
排除标准
- •Individuals with active implantable medical devices (e.g. electronic heart implant, electrical neurophysiological stimulator…);
- •Individuals with mechanical heart valves;
- •Individuals with chest deformity preventing the phone to be correctly placed on the chest
- •Individuals with uncontrolled psychiatric conditions impairing their ability to fully consent to the study
- •Individuals suffering from epilepsy or an associated disorder;
- •Individuals suffering from a moderate to severe valvular disease;
- •Individuals under CPAP treatment during the participation.
- •Individuals suffering from a nervous system disorder that causes unintended or uncontrollable movements, other than periodic leg movement syndrome and restless leg syndrome.
- •Refusal to participate in the study at any time during the clinical investigation;
- •Individuals in period of exclusion from another protocol or currently participating in another interventional research study;
- •Individuals not able to understand and speak the official language of the research center;
- •Vulnerable individuals according to local legislation
结局指标
主要结局
Performance of Apneal® in categorizing SAHS severity using AHI
时间窗: through study completion, an average of 1 year
The primary endpoint of this study is the performance of Apneal® in categorizing SAHS severity in four classes compared to PSG: normal (AHI \< 5), mild (5 ≤ AHI \< 15), moderate (15 ≤ AHI \< 30), and severe (AHI ≥ 30)
次要结局
- Correlation between AHI from Apneal and Berlin score(through study completion, an average of 1 year)
- Correlation between AHI from Apneal and AHI from PSG(through study completion, an average of 1 year)
- Correlation between AHI from Apneal and Epworth sleepiness scale (ESS) score(through study completion, an average of 1 year)
- Correlation between AHI from Apneal and AHI from nocturnal polygraphy(through study completion, an average of 1 year)
- Correlation between AHI from apneal and ODI from nocturnal oximetry(through study completion, an average of 1 year)
- Correlation between AHI from Apneal and STOPBANG score(through study completion, an average of 1 year)
- The segmentation of the night in snores and non-snores periods(through study completion, an average of 1 year)
- Wake/night detection(through study completion, an average of 1 year)
- Correlation between AHI from Apneal and NoSAS score(through study completion, an average of 1 year)
- The classification of sleep epochs into three categories : wake, REM sleep and NREM sleep (N1, N2 or N3).(through study completion, an average of 1 year)
- Heart rate(through study completion, an average of 1 year)
- Autonomic sleep fragmentation(through study completion, an average of 1 year)
- Central apnea index(through study completion, an average of 1 year)
- Position detection(through study completion, an average of 1 year)
- Medicoeconomic study(through study completion, an average of 1 year)
研究者
研究点 (1)
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