Post Discharge Circadian Rhythms Post Adenotonsillectomy
Post Discharge Circadian Dysrhythmias, Sleep Disturbances, and Return to Baseline Activity in Children With Pre-existing Obstructive Sleep Apnea After AT (Adenotonsillectomy).
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).
研究概览
详细说明
研究类型
联系人和位置
学习地点
-
-
Texas
-
Houston、Texas、美国、77030
- Texas Childrens Hospital
-
-
参与标准
资格标准
适合学习的年龄
接受健康志愿者
有资格学习的性别
取样方法
研究人群
描述
Inclusion Criteria:
- As stated previously, OSA v. non OSA
Exclusion Criteria:
-
学习计划
研究是如何设计的?
设计细节
- 观测模型:队列
- 时间观点:预期
队列和干预
团体/队列 |
干预/治疗 |
|---|---|
|
Children without OSA
Children for AT due to chronic tonsillitis without OSA.
|
Wrist worn wearable technology will be utilized to study HR, temperature, sleep, activity changes before and after surgery.
|
|
Children with OSA
Children with OSA for AT as determined by PSG
|
Wrist worn wearable technology will be utilized to study HR, temperature, sleep, activity changes before and after surgery.
|
研究衡量的是什么?
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Change in circadian rhythm
大体时间:3 week
|
HR (heart rate) in OSA (obstructive sleep apnea) group v. non OSA group post AT
|
3 week
|
|
Change in circadian rhythm
大体时间: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.
|
3 weeks
|
|
Change in activity
大体时间: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.
|
3 week
|
合作者和调查者
研究记录日期
研究主要日期
学习开始 (实际的)
初级完成 (实际的)
研究完成 (实际的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (实际的)
研究记录更新
最后更新发布 (实际的)
上次提交的符合 QC 标准的更新
最后验证
更多信息
此信息直接从 clinicaltrials.gov 网站检索,没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求,请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改,我们的网站上也会自动更新.