52
Participants
Start Date
July 27, 2022
Primary Completion Date
December 25, 2024
Study Completion Date
August 31, 2025
Sparrow Fledging Therapy System
tAN sessions will be administered up to four times per day for up to 20 days total. Active tAN will be set to run for 30 minutes one hour prior to each planned morphine dose. When the 30-minute tAN session is complete, the system will be turned off and unplugged.
Sham Sparrow Fledging Therapy System
Participants randomized to the sham group will have the device earpiece applied at the same timepoints and for the same duration as the active group, but stimulation will not be turned on. tAN sessions will be administered up to four times per day for up to 20 days total. Sham tAN will be set to run for 30 minutes one hour prior to each planned morphine dose. When the 30-minute tAN session is complete, the system will be turned off and unplugged.
Medical University of South Carolina - Shawn Jenkins Children's Hospital, Charleston
UT Southwestern Medical Center / Parkland Memorial Hospital, Dallas
University of Texas Health Science Center San Antonio, San Antonio
Medical University of South Carolina
OTHER
University of Texas Southwestern Medical Center
OTHER
University of Texas Health Science Center San Antonio
UNKNOWN
Spark Biomedical, Inc.
INDUSTRY