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).

Study Overview

• Status: Withdrawn
• Conditions: Circadian Dysrhythmia
• Intervention / Treatment: Device: Jawbone UP4

Detailed Description

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.

• Study Type: Observational

Contacts and Locations

Study Locations

• United States
  • Texas
    • Houston, Texas, United States, 77030
      • Texas childrens Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 5 years to 10 years (Child)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

We are testing variability in circadian biomarkers

Description

Inclusion Criteria:

• As stated previously, OSA v. non OSA

Exclusion Criteria:

-

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Children without OSA; Children for AT due to chronic tonsillitis without OSA.	Device: Jawbone UP4; 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	Device: Jawbone UP4; Wrist worn wearable technology will be utilized to study HR, temperature, sleep, activity changes before and after surgery.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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

Collaborators and Investigators

• Sponsor: Baylor College of Medicine

Study record dates

Study Major Dates

• Study Start (Actual): August 21, 2017
• Primary Completion (Actual): March 17, 2022
• Study Completion (Actual): March 17, 2022

Study Registration Dates

• First Submitted: April 25, 2017
• First Submitted That Met QC Criteria: July 12, 2017
• First Posted (Actual): July 14, 2017

Study Record Updates

• Last Update Posted (Actual): March 31, 2022
• Last Update Submitted That Met QC Criteria: March 17, 2022
• Last Verified: March 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Heart Diseases; Cardiovascular Diseases; Arrhythmias, Cardiac
• Other Study ID Numbers: H-39906

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes