Post Discharge Circadian Rhythms Post Adenotonsillectomy
Study Details
Study Description
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 | Phase |
|---|---|---|
|
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
Arms and Interventions
| Arm | 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
Primary Outcome Measures
- Change in circadian rhythm [3 week]
HR (heart rate) in OSA (obstructive sleep apnea) group v. non OSA group post AT
- Change in circadian rhythm [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.
- Change in activity [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
Criteria
Inclusion Criteria:
- As stated previously, OSA v. non OSA
Exclusion Criteria:
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Texas Childrens Hospital | Houston | Texas | United States | 77030 |
Sponsors and Collaborators
- Baylor College of Medicine
Investigators
None specified.Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- H-39906