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临床试验/NCT05949853
NCT05949853进行中(未招募)不适用

Enhanced Respiratory Polygraphy (PV_e) Using Single Channel EEG-based Automatic Sleep Scoring in Suspected Obstructive Sleep Apnea: Feasibility and Efficiency as Compared With Polygraphy and Polysomnography

Hospices Civils de Lyon1 个研究点 分布在 1 个国家目标入组 30 人开始时间: 2023年1月1日最近更新:
适应症

试验速览

阶段
不适用
状态
进行中(未招募)
入组人数
30
试验地点
1
主要终点
Apnea Hypopnea Index as assessed by PSG

研究概览

简要总结

Obstructive Sleep Apnea (OSA) remains underdiagnosed in 2022, as a result of the unawareness of its serious health-related consequences and the lack of diagnosis accessibility. Respiratory polygraphy (PV) is widely used as a screening tool and sometimes a diagnosis test, although polysomnography (PSG) remains the gold standard investigation as it provides complete information about sleep architecture and arousals. Thus, it has been shown that the Apnea Hypopnea Index (AHI) and Respiratory Disorder Index (RDI) are underestimated by PV vs PSG. Approaches to substitute PSG by simpler but equally efficient diagnosis tests have included devices aiming to record complementary signals and to analyze them with Artificial Intelligence. In this context, ASEEGA algorithm has demonstrated its performance for automatic sleep scoring in healthy individuals and patients with various sleep disorders, based on a single channel EEG analysis.

This study aims at comparing the real-life performance and feasibility of added single channel EEG automatic sleep scoring using ASEEGA to PV versus standard PV and PSG in adults referred to a regional sleep reference center for suspected OSA.

We hypothesize that this approach (1) is as accurate as PSG and more accurate that PV for AHI analysis, and (2) is less time-consuming than PSG.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Retrospective

入排标准

年龄范围
18 Years 至 99 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Hospitalized at the Center for Sleep Medicine and Respiratory Diseases, Hôpital de la Croix-Rousse, Lyon Academic Hospital, Lyon between 09/2022 and 11/2022 for PSG following suspected OSA .

排除标准

  • Unreliable sleep scoring due to artefacts (> 10% of the recording) or to epileptic abnormalities on the electroencephalography recordings
  • Presence of other suspected sleep disorder: central hypersomnia, rapid-eye-movement (REM) or non-REM sleep parasomnia, sleep-related motor disorders...
  • Ongoing psychotropic medication
  • Opposition of the patient to the use of their data.

结局指标

主要结局

Apnea Hypopnea Index as assessed by PSG

时间窗: analysis will start in January 2023 and should be completed after 6 months.

Apnea Hypopnea Index will be scored by 2 sleep medical experts at 3 occurrences separated by 1 months interval in a random order (PSG/PV/PV+ASEEGA). Apnea Hypopnea Index in the three groups (PSG/PV/PV+ASEEGA) will be compared with Friedmann test or one factor ANOVA for paired data, according to data distribution, for each scorer

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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