跳至主要内容
临床试验/NCT03217708
NCT03217708撤回不适用

Post Discharge Circadian Dysrhythmias, Sleep Disturbances, and Return to Baseline Activity in Children With Pre-existing Obstructive Sleep Apnea After AT (Adenotonsillectomy).

Baylor College of Medicine1 个研究点 分布在 1 个国家开始时间: 2017年8月21日最近更新:
适应症

试验速览

阶段
不适用
状态
撤回
试验地点
1
主要终点
Change in activity

研究概览

简要总结

The purpose of this study is to utilize non-invasive, easily measurable biomarkers (heart rate, skin temperature, sleep, and activity) in the post surgical discharge period to identify trends which correlate with improved outcome and early recovery (return to baseline activity). These are measured (captured) utilizing a wearable technology (WT) device.

Return to baseline (RTB) activity for the purpose of this study is defined primarily as step count normalization as a surrogate of activity (pre versus post operative step count), and heart rate variability normalization back to preoperative baseline. Increased heart rate variability has been studied in acute care settings as a marker of poor prognosis. Please note that return to baseline is not defined for the pediatric population in the same way as adults (which is primarily questionnaire based and not applicable in children).

详细描述

Wearable technology has tremendous advantages over current methods of assessing RTB activity in the post-discharge pediatric population after AT, which rely on quality of life (QOL) scales, caregiver and patient reports, as well as nurse phone calls and office visits. These methods are biased, time and labor intensive, disease focused, and caregiver dependent. The investigators propose to use wearable technology in order to assess RTB activity. The device has validated methodology in sleep metrics (as compared to polysomnography), heart rate and activity monitoring (optical sensor and 3 plane accelerometry), and temperature measuring (galvanic skin resistance). So far, no investigators have utilized wearable technology and biomarker (heart rate, skin temperature, activity, sleep) data in the manner proposed. RTB is a difficult to measure entity in children and the investigators have defined it using step count as a marker of activity. There are no studies or "standard" to measure quality of recovery in children.

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
5 Years 至 10 Years(Child)
性别
All
接受健康志愿者

入选标准

  • As stated previously, OSA v. non OSA

排除标准

  • 未提供

结局指标

主要结局

Change in activity

时间窗: 3 week

Activity change in OSA group v. non OSA group post AT. Due to the device being able to measure activity (specifically measured as step count as indicated in the introduction), these can be compared between groups.

Change in circadian rhythm

时间窗: 3 weeks

Sleep in OSA group v. non OSA group post AT. Specifically the design will capture sleep metrics (REM v. non REM, arousals, movement) in order to assess sleep quality.

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Arvind Chandrakantan

Assistant Professor of Anesthesiology and Pediatrics

Baylor College of Medicine

研究点 (1)

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