Post Discharge Circadian Rhythms Post Adenotonsillectomy
| Status: | Recruiting |
|---|---|
| Conditions: | Cardiology |
| Therapuetic Areas: | Cardiology / Vascular Diseases |
| Healthy: | No |
| Age Range: | 5 - 10 |
| Updated: | 1/20/2018 |
| Start Date: | August 21, 2017 |
| End Date: | December 31, 2018 |
| Contact: | Kimberly Mayfield |
| Email: | kim.mayfield@bcm.edu |
| Phone: | 8328284000 |
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).
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).
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.
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.
Inclusion Criteria:
- As stated previously, OSA v. non OSA
Exclusion Criteria:
We found this trial at
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Texas Children's Hospital Texas Children's Hospital, located in Houston, Texas, is a not-for-profit organization whose...
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