Status:
RECRUITING
Transcutaneous Auricular Vagus Nerve Stimulation for Insomnia in Survivors of Childhood Acute Lymphoblastic Leukemia
Lead Sponsor:
St. Jude Children's Research Hospital
Conditions:
Survivor of Childhood Cancer
Insomnia
Eligibility:
All Genders
20-50 years
Phase:
NA
Brief 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 lym...
Detailed Description
Approximately 40 adult survivors of childhood ALL enrolled in the SJLIFE cohort will be recruited. Eligible participants must have moderate to severe insomnia (ISI ≥8). The intervention involves night...
Eligibility Criteria
Inclusion
- 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
- 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)
- 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
Key Trial Info
Start Date :
January 1 2026
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 1 2029
Estimated Enrollment :
40 Patients enrolled
Trial Details
Trial ID
NCT07191119
Start Date
January 1 2026
End Date
December 1 2029
Last Update
December 16 2025
Active Locations (1)
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1
St. Jude Children's Research Hospital
Memphis, Tennessee, United States, 38105