Actively Recruiting
Transcutaneous Auricular Vagus Nerve Stimulation for Insomnia in Survivors of Childhood Acute Lymphoblastic Leukemia
Led by St. Jude Children's Research Hospital · Updated on 2026-04-24
40
Participants Needed
1
Research Sites
191 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Transcutaneous Auricular Vagus Nerve Stimulation for Insomnia in Survivors of Childhood Acute Lymphoblastic Leukemia
Who Can Participate
Eligibility Criteria
You may qualify if you...
- 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 �3E=8 (Proxy �3E=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
You will not qualify if you...
- 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)
- 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 health condition including:
- Cranial Nerve Disorder (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
AI-Screening
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Trial Site Locations
Total: 1 location
1
St. Jude Children's Research Hospital
Memphis, Tennessee, United States, 38105
Actively Recruiting
Research Team
J
Justin E Tanner, PhD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
DEVICE_FEASIBILITY
Number of Arms
2
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