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

Official record

Identifier

NCT07191119

Recruiting locations

country

United States

Interventions studied

Soterix tVNS deviceSoterix tVNS device (sham programmed)Sleep QualityNeurocognitive and mental health outcomes

Lead sponsor

St. Jude Children's Research Hospital

Target enrolment

40 participants

Study type

INTERVENTIONAL

Phase

Not applicable

Status

Recruiting

First posted

Sep 24, 2025

Last updated on the registry

Aug 14, 2026

Age

20 Years – 50 Years

Sex

ALL

Study contact

The official record lists a study contact. Contact details are published there and are intentionally not copied to this page.

Eligibility criteria

Reproduced verbatim from the official record. Eligibility is decided by the study team, never by this page.

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

Indexed under

Lymphoma