Ignite Creation Date:
2024-05-06 @ 8:19 PM
Last Modification Date:
2024-10-26 @ 3:25 PM
Study NCT ID:
NCT06337526
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-05-09
First Post:
2024-03-22
Brief Title:
Predicting Pain Exacerbations in Children With Complex Regional Pain Syndrome CRPS
Sponsor:
Stanford University
Organization:
Stanford University
Study Overview
Official Title:
Identifying Factors Associated With Acute Pain Exacerbation in Children With Complex Regional Pain Syndrome CRPS A Novel Research Plan
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
objectives identify physiologic dietary and environment triggers of severe pain exacerbations in children with CRPS
Detailed Description:
Hypothesises and Aims Investigators hypothesize that spontaneous exacerbations flares of limb pain caused by CRPS have identifiable and predictable precipitants and timing The aim of this trial is 1 to aggregate large databases of real-time physiological psychological subjective pain environmental and dietary data and analyze these data with artificial intelligence AI to identify temporal precipitants to pain exacerbations and 2 to identify potential strategies to interrupt the progression of acute pain flares based upon what is learned Early treatment and strategies to interrupt acute pain flares would have a significant effect on quality of life in this patient population while undergoing treatment and resolution of the ongoing condition
Design Design of the study prospective observational study Subjects will be recruited from Stanfords pediatric pain clinic and other like centers nation-wide Subjects will be issued an Apple Watch and the Medeloop app for data collection Data collection Medeloop will collect subjects electronic medical records existing and prospective if subjects sign into the hospitals patient portal through Medeloop
The Apple Watch will transmit physiologic data to Medeloop in real time for a period of 6 months to derive physiologic parameters from Apple Watch measured pulse rate oxygen saturation time in daylight ECG measurement and movementactivity Derived variables include heart rate variability sleep hours daily distance walked rightleft weight bearing and gait and others Using a paired smartphone subjects will photograph all meals for analysis of the dietary content by AI which will be transmitted to Medeloop after capture for AI analysis Medeloop software will use location data and cross-reference corresponding environmental and weather data eg atmospheric conditions air and water quality on a daily basis All pain flares will be recorded in real time via the Medeloop app
Design Design of the study prospective observational study Subjects will be recruited from Stanfords pediatric pain clinic and other like centers nation-wide Subjects will be issued an Apple Watch and the Medeloop app for data collection Data collection Medeloop will collect subjects electronic medical records existing and prospective if subjects sign into the hospitals patient portal through Medeloop
The Apple Watch will transmit physiologic data to Medeloop in real time for a period of 6 months to derive physiologic parameters from Apple Watch measured pulse rate oxygen saturation time in daylight ECG measurement and movementactivity Derived variables include heart rate variability sleep hours daily distance walked rightleft weight bearing and gait and others Using a paired smartphone subjects will photograph all meals for analysis of the dietary content by AI which will be transmitted to Medeloop after capture for AI analysis Medeloop software will use location data and cross-reference corresponding environmental and weather data eg atmospheric conditions air and water quality on a daily basis All pain flares will be recorded in real time via the Medeloop app
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None