RecruitingNot ApplicableNCT07191119

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

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

Sponsor

St. Jude Children's Research Hospital

Enrollment

40 participants

Start Date

Mar 31, 2026

Study Type

INTERVENTIONAL

Conditions

Insomnia Survivor of Childhood Cancer

Summary

This pilot study will assess the usefulness and potential effectiveness of using transcutaneous auricular vagus nerve stimulation (tVNS) for treating insomnia in adult survivors of childhood acute lymphoblastic leukemia (ALL). Participants will be randomized to receive either active (verum) or inactive (sham) nightly stimulation using a non-invasive earbud device over two time periods: 2 weeks and 8 weeks. The study will assess adherence to the intervention and estimate its effects on sleep quality, stress, and neurocognitive function. Primary 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

Min Age: 20 YearsMax Age: 50 Years

Plain Language Summary

Simplified for easier understanding

This study is testing a device that stimulates a nerve near the ear (auricular vagus nerve stimulation) as a non-drug treatment for insomnia in young adult survivors of childhood leukemia (ALL). The stimulation is applied through a small clip worn on the ear. **You may be eligible if...** - You are a survivor of childhood acute lymphoblastic leukemia (ALL) - You were diagnosed before age 21 and are now between 20 and 50 years old - You are enrolled in the SJLIFE long-term follow-up study - You score 8 or above on the Insomnia Severity Index - You have home Wi-Fi and a smartphone - You speak and understand English **You may NOT be eligible if...** - You have a pacemaker or other implanted electrical device - You are pregnant or planning to become pregnant - You take medication for seizures or neurocognitive issues like stimulants - You currently use a CPAP or other technology device for sleep problems - You have a history of serious heart, vascular, or neurological conditions (above a certain severity threshold) Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DEVICESoterix 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.

DEVICESoterix 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.

BEHAVIORALSleep Quality

Receive Pittsburgh Sleep Quality Index (PSQI); Insomnia Severity Index (ISI); Sleep diaries; Actigraphy via Fitbit Charge 5

BEHAVIORALNeurocognitive and mental health outcomes

Measured using CNS Vital Signs and DASS-21.