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

RecruitingNAAges 20 Years - 50 YearsAllSt. Jude Children's Research Hospital
NCT07191119 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

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

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📋 Eligibility rules (as published)
Inclusion Criteria: * 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 Exclusion Criteria: * Unable to understand the details and requirements of the study (at the discretion of the PI) * Female participants who are pregnant or planning to become pregnant * Presence of implanted electrical medical devices (i.e. pacemaker) * Currently taking medication intended to treat neurocognitive impairment (i.e. stimulants) or medications prescribed for seizure management * History of skin irritation or other issues during stimulation of inner ear * Currently utilizing a technological intervention for a sleep disorder (e.g. CPAP) * Medications and behavioral practices (white noise, night-time yoga, etc) are acceptable as long as the insomnia is persistent. * History of a contraindicated health condition including: * Syncope (CTCAE \>2) * Cardiac dysrhythmia (CTCAE \>2) * Vascular Disease (CTCAE \>2) * Coronary Artery Disease (CTCAE \>2) * Active contraindicated heath condition including: * Cranial Nerve Disorder (CTCAE \>2) * Cardiac tachycardia (CTCAE \>2) * Neuropathy (Cranial Nerves) (CTCAE \>2) * Neuralgia (Cranial Nerves) (CTCAE \>2) * Overt Cerebrovascular Accident (CTCAE \>2) * Seizures (Any in most recent 1 year * Currently enrolled or participating in any other neurostimulation or neuromodulation ancillary research studies
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What it tests

  • Soterix tVNS device
  • Soterix tVNS device (sham programmed)
  • Sleep Quality
  • Neurocognitive and mental health outcomes
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Where

1 site
St. Jude Children's Research Hospital
Memphis, United States
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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