Transcutaneous Auricular Vagus Nerve Stimulation for Insomnia in Survivors of Childhood Acute Lymphoblastic Leukemia
NCT ID: NCT07191119
Last Updated: 2025-12-16
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
40 participants
INTERVENTIONAL
2026-01-31
2029-12-31
Brief Summary
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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.
Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
While "Device Feasibility" generally has fewer than 10 participants, the aim is to ensure safety in a novel device population. While this does not fit into "Supportive Care," it also requires more participants for considerations:
* Using a blinded 1:1 sham:verum study design with a control arm to ensure device feasibility is not affected by perceived stimulation. It is important to consider the inherent experience of tVNS.
* As this is a novel population for the device and treatment, the study aims to ensure an adequate sample size to obtain effect size estimates to inform power analyses on future trials will be achieved.
DEVICE_FEASIBILITY
NONE
Study Groups
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Verum tVNS (Active Treatment)
Participants randomized to receive 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.
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.
Sleep Quality
Receive Pittsburgh Sleep Quality Index (PSQI); Insomnia Severity Index (ISI); Sleep diaries; Actigraphy via Fitbit Charge 5
Neurocognitive and mental health outcomes
Measured using CNS Vital Signs and DASS-21.
Sham tVNS (Placebo Comparator)
Participants randomized to receive sham stimulation using the same Soterix device, but with no active electrical stimulation. The procedure mimics the verum condition in duration and setup.
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.
Sleep Quality
Receive Pittsburgh Sleep Quality Index (PSQI); Insomnia Severity Index (ISI); Sleep diaries; Actigraphy via Fitbit Charge 5
Neurocognitive and mental health outcomes
Measured using CNS Vital Signs and DASS-21.
Interventions
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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.
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.
Sleep Quality
Receive Pittsburgh Sleep Quality Index (PSQI); Insomnia Severity Index (ISI); Sleep diaries; Actigraphy via Fitbit Charge 5
Neurocognitive and mental health outcomes
Measured using CNS Vital Signs and DASS-21.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* 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
20 Years
50 Years
ALL
No
Sponsors
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St. Jude Children's Research Hospital
OTHER
Responsible Party
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Principal Investigators
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Justin E Tanner, PhD
Role: PRINCIPAL_INVESTIGATOR
St. Jude Children's Research Hospital
Locations
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St. Jude Children's Research Hospital
Memphis, Tennessee, United States
Countries
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Central Contacts
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Facility Contacts
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Related Links
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St. Jude Children's Research Hospital
Other Identifiers
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FANSI
Identifier Type: -
Identifier Source: org_study_id