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

NANot yet recruitingINTERVENTIONAL
Enrollment

40

Participants

Timeline

Start Date

November 30, 2025

Primary Completion Date

September 30, 2027

Study Completion Date

September 30, 2029

Conditions
Survivor of Childhood CancerInsomniaAcute Lymphoblastic Leukemia (ALL)
Interventions
DEVICE

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."

DEVICE

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.

BEHAVIORAL

Sleep Quality

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

BEHAVIORAL

Neurocognitive and mental health outcomes

Measured using CNS Vital Signs and DASS-21.

Trial Locations (1)

38105

St. Jude Children's Research Hospital, Memphis

All Listed Sponsors
lead

St. Jude Children's Research Hospital

OTHER