40
Participants
Start Date
November 30, 2025
Primary Completion Date
September 30, 2027
Study Completion Date
September 30, 2029
Soterix tVNS device
"Active transcutaneous auricular vagus nerve stimulation (tVNS) using the Soterix device.~Stimulation is delivered nightly for 20 minutes at 80% of the participant's discomfort threshold."
Soterix tVNS device (sham programmed)
The sham stimulation used the Soterix device, but without active electrical stimulation. The procedure mimics the verum condition in duration and setup. Inactive stimulation is delivered nightly for 20 minutes at 80% of the participant's discomfort threshold.
Sleep Quality
Receive Pittsburgh Sleep Quality Index (PSQI); Insomnia Severity Index (ISI); Sleep diaries; Actigraphy via Fitbit Charge 5
Neurocognitive and mental health outcomes
Measured using CNS Vital Signs and DASS-21.
St. Jude Children's Research Hospital, Memphis
St. Jude Children's Research Hospital
OTHER