Study Stopped
Non compliance from sponsor regarding applicable documentation to proceed with trial, therefore decision to permanently halt trial
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).
1 other identifier
observational
N/A
1 country
1
Brief 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).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
Started Aug 2017
Longer than P75 for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
April 25, 2017
CompletedFirst Posted
Study publicly available on registry
July 14, 2017
CompletedStudy Start
First participant enrolled
August 21, 2017
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 17, 2022
CompletedStudy Completion
Last participant's last visit for all outcomes
March 17, 2022
CompletedMarch 31, 2022
March 1, 2022
4.6 years
April 25, 2017
March 17, 2022
Conditions
Outcome Measures
Primary Outcomes (3)
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
Study Arms (2)
Children without OSA
Children for AT due to chronic tonsillitis without OSA.
Children with OSA
Children with OSA for AT as determined by PSG
Interventions
Wrist worn wearable technology will be utilized to study HR, temperature, sleep, activity changes before and after surgery.
Eligibility Criteria
We are testing variability in circadian biomarkers
You may qualify if:
- As stated previously, OSA v. non OSA
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Texas Childrens Hospital
Houston, Texas, 77030, United States
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Target Duration
- 3 Weeks
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Assistant Professor of Anesthesiology and Pediatrics
Study Record Dates
First Submitted
April 25, 2017
First Posted
July 14, 2017
Study Start
August 21, 2017
Primary Completion
March 17, 2022
Study Completion
March 17, 2022
Last Updated
March 31, 2022
Record last verified: 2022-03
Data Sharing
- IPD Sharing
- Will not share