Post Discharge Circadian Rhythms Post Adenotonsillectomy

NCT ID: NCT03217708

Last Updated: 2022-03-31

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

WITHDRAWN

Study Classification

OBSERVATIONAL

Study Start Date

2017-08-21

Study Completion Date

2022-03-17

Brief Summary

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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).

Detailed Description

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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.

Conditions

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Circadian Dysrhythmia

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Children without OSA

Children for AT due to chronic tonsillitis without OSA.

Jawbone UP4

Intervention Type DEVICE

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

Jawbone UP4

Intervention Type DEVICE

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

Interventions

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Jawbone UP4

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

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

* As stated previously, OSA v. non OSA

Exclusion Criteria

\-
Minimum Eligible Age

5 Years

Maximum Eligible Age

10 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Baylor College of Medicine

OTHER

Sponsor Role lead

Responsible Party

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Arvind Chandrakantan

Assistant Professor of Anesthesiology and Pediatrics

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Texas Childrens Hospital

Houston, Texas, United States

Site Status

Countries

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United States

Other Identifiers

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H-39906

Identifier Type: -

Identifier Source: org_study_id

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