Feasibility and Efficacy of Transcutaneous Auricular Vagus Nerve Stimulation for Insomnia in Survivors of Childhood Acute Lymphoblastic Leukemia

Status: Recruiting
Location: See location...
Intervention Type: Device, Behavioral
Study Type: Interventional
Study Phase: Not Applicable
SUMMARY

Objective: Aim 1: To determine a) short-term and b) long-term feasibility of tVNS in terms of participation in ALL Survivors with moderate to severe insomnia. Aim 2: To estimate the effect size of tVNS on sleep quality, stress, and neurocognitive outcomes in ALL survivors with insomnia. Exploratory Objectives Aim 1: To investigate the onset of tVNS effect via actigraphy measures over the intervention epoch. Aim 2: To estimate the effect size of genetic variants on sleep quality within verum tVNS.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 20
Maximum Age: 50
Healthy Volunteers: f
View:

• Survivor of Acute Lymphoblastic Leukemia (ALL)

• Enrolled on SJLIFE

• Participant was less than 21 years of age at time of diagnosis.

• Age 20-50 years at the time of enrollment

• Insomnia Severity Index \>=8 (Proxy \>=8) confirmed prior to enrollment

• Access to home Wi-Fi and Smartphone

• Participant is able to speak and understand the English language

• Participant is able and willing to give consent

Locations
United States
Tennessee
St. Jude Children's Research Hospital
RECRUITING
Memphis
Contact Information
Primary
Justin E Tanner, PhD
referralinfo@stjude.org
866-278-5833
Time Frame
Start Date: 2026-01
Estimated Completion Date: 2029-12
Participants
Target number of participants: 40
Treatments
Experimental: Verum tVNS (Active Treatment)
Participants randomized to receive 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.
Sham_comparator: Sham tVNS (Placebo Comparator)
Participants randomized to receive sham stimulation using the same Soterix device, but with no active electrical stimulation. The procedure mimics the verum condition in duration and setup.
Sponsors
Leads: St. Jude Children's Research Hospital

This content was sourced from clinicaltrials.gov