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Non compliance from sponsor regarding applicable documentation to proceed with trial, therefore decision to permanently halt trial
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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).
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Children without OSA | Children for AT due to chronic tonsillitis without OSA. |
| |
| Children with OSA | Children with OSA for AT as determined by PSG |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Jawbone UP4 | Device | Wrist worn wearable technology will be utilized to study HR, temperature, sleep, activity changes before and after surgery. |
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| Measure | Description | Time Frame |
|---|---|---|
| Change in circadian rhythm | HR (heart rate) in OSA (obstructive sleep apnea) group v. non OSA group post AT | 3 week |
| Change in circadian rhythm | 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 | 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 |
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Inclusion Criteria:
Exclusion Criteria:
-
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We are testing variability in circadian biomarkers
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Texas Childrens Hospital | Houston | Texas | 77030 | United States |
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