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Post Discharge Circadian Rhythms Post Adenotonsillectomy

NCT03217708 · Status: WITHDRAWN · Type: OBSERVATIONAL

Last updated 2022-03-31

No results posted yet for this study

Summary

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).

Conditions

  • Circadian Dysrhythmia

Interventions

DEVICE

Jawbone UP4

Wrist worn wearable technology will be utilized to study HR, temperature, sleep, activity changes before and after surgery.

Sponsors & Collaborators

  • Baylor College of Medicine

    lead OTHER

Eligibility

Min Age
5 Years
Max Age
10 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-08-21
Primary Completion
2022-03-17
Completion
2022-03-17
FDA Device
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03217708 on ClinicalTrials.gov