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Post Discharge Circadian Rhythms Post Adenotonsillectomy

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03217708
Recruitment Status : Withdrawn (Non compliance from sponsor regarding applicable documentation to proceed with trial, therefore decision to permanently halt trial)
First Posted : July 14, 2017
Last Update Posted : March 31, 2022
Sponsor:
Information provided by (Responsible Party):
Arvind Chandrakantan, Baylor College of Medicine

Study Description
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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).


Condition or disease Intervention/treatment
Circadian Dysrhythmia 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 Design
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Study Type : Observational [Patient Registry]
Actual Enrollment : 0 participants
Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration: 3 Weeks
Official Title: Post Discharge Circadian Dysrhythmias, Sleep Disturbances, and Return to Baseline Activity in Children With Pre-existing Obstructive Sleep Apnea After AT (Adenotonsillectomy).
Actual Study Start Date : August 21, 2017
Actual Primary Completion Date : March 17, 2022
Actual Study Completion Date : March 17, 2022

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Arrhythmia

Groups and Cohorts
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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.


Outcome Measures
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Primary Outcome Measures :
  1. Change in circadian rhythm [ Time Frame: 3 week ]
    HR (heart rate) in OSA (obstructive sleep apnea) group v. non OSA group post AT

  2. Change in circadian rhythm [ Time Frame: 3 weeks ]
    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. Change in activity [ Time Frame: 3 week ]
    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.


Eligibility Criteria
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Ages Eligible for Study:   5 Years to 10 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
We are testing variability in circadian biomarkers
Criteria

Inclusion Criteria:

  • As stated previously, OSA v. non OSA

Exclusion Criteria:

-

Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03217708


Locations
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United States, Texas
Texas Childrens Hospital
Houston, Texas, United States, 77030
Sponsors and Collaborators
Baylor College of Medicine
More Information
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Additional Information:

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Responsible Party: Arvind Chandrakantan, Assistant Professor of Anesthesiology and Pediatrics, Baylor College of Medicine
ClinicalTrials.gov Identifier: NCT03217708    
Other Study ID Numbers: H-39906
First Posted: July 14, 2017    Key Record Dates
Last Update Posted: March 31, 2022
Last Verified: March 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Additional relevant MeSH terms:
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Arrhythmias, Cardiac
Heart Diseases
Cardiovascular Diseases
Pathologic Processes