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临床试验/NCT05575921
NCT05575921尚未招募不适用

Diagnostic of Sleep Obstructive Apnea Syndrome in Children by Home Sleep Studies

Central Hospital, Nancy, France0 个研究点目标入组 44 人开始时间: 2022年10月10日最近更新:
适应症

试验速览

阶段
不适用
状态
尚未招募
发起方
入组人数
44
主要终点
At-home PG has the same diagnostic value than at-home PSG

研究概览

简要总结

Obstructive Sleep Apnea Syndrome (OSAS) in children is a significant public health problem whose clinical diagnosis is not specific. The recording of sleep and breathing (polysomnography, PSG) is the reference exam. PSG consists in installing on the child's body electrodes necessary to determine the sleep stages and sensors used to determine the presence of respiratory events during sleep. At-home PSG, compared to hospital PSG, improves sleep quality. PSG is yet an anxious exam due to the multitude of electrodes and sensors. Ventilatory polygraphy (PG) consists of installing only respiratory detectors.

The objective of this study is to demonstrate that at-home PG has the same diagnostic value as at-home PSG.

详细描述

Obstructive Sleep Apnea Syndrome (OSAS) in children causes chronic hematosis disorders and sleep disruption that negatively impacts growth, neurocognitive performance, and cardiovascular and metabolic functions. Its high frequency makes it a major public health problem. The clinical elements for the diagnosis are not specific and the recording of sleep and breathing (polysomnography, PSG) is the reference exam (HAS Recommendations, 2012). PSG consists in installing on a child's body electroencephalogram (EEG), electrooculogram (EOG), and electromyogram (EMG) electrodes, necessary to determine the sleep stages and sleep-wake periods, and also the sensors used to determine the presence of respiratory events during sleep such as a nasal cannula, thoracoabdominal belts, oximetry, and actimetry. At-home PSG, compared to hospital PSG, improves sleep quality and diagnostic conditions. But the PSG remains a rather anxious exam for the child due to the multitude of electrodes and sensors. Ventilatory polygraphy (PG) consists of installing only the respiratory detectors (nasal cannula, thoracoabdominal belts, oximetry, and actimetry), without the EEG, EOG, and EMG electrodes. Several studies in the literature have compared these 2 exams, PSG and PG, for diagnosing OSAS in children with varied and sometimes contradictory results.

The hypothesis of the study is that the obstructive apnea-hypopnea index (OAHI, the number of apneas, and obstructive hypopneas per hour) obtained by at-home PSG and the OAHI obtained by at-home PG are not different. For this, the sleep physician will analyze the sleep recording performed at home in routine clinical practice, in 2 ways: 1) by determining the sleep stages and computing OAHI per hour of sleep; 2) by removing EEG, EOG, and EMG signals and computing OAHI over the duration of the sleep estimated by the physician according to child's behavior during sleep (movements, artifacts) as in PG.

The main objective of this study is to demonstrate that at-home PG has the same diagnostic value as at-home PSG, i.e. OAHI obtained by at-home PG is similar to OAHI obtained by at-home PSG. The second objective is to determine the faisability in terms of the percentage of interpretable exams of at-home 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
2 Years 至 18 Years(Child, Adult)
性别
All
接受健康志愿者

入选标准

  • Data from at-home PSG retrospectively collected from the hospital recording of children who underwent an exam during the period October 2020 to March 2021

排除标准

  • 未提供

结局指标

主要结局

At-home PG has the same diagnostic value than at-home PSG

时间窗: One night

OAHI obtained by at-home PG is similar to OAHI obtained by at-home PSG

次要结局

  • At-home PSG faisability(1 hour)

研究者

发起方
Central Hospital, Nancy, France
申办方类型
Other
责任方
Principal Investigator
主要研究者

Dr. Iulia IOAN

MD PhD Associate Professor

Central Hospital, Nancy, France

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