NCT07191119Recruiting
Transcutaneous Auricular Vagus Nerve Stimulation for Insomnia in Survivors of Childhood Acute Lymphoblastic Leukemia
Feasibility and Efficacy of Transcutaneous Auricular Vagus Nerve Stimulation for Insomnia in Survivors of Childhood Acute Lymphoblastic Leukemia
Source: ClinicalTrials.gov · Last updated 14 Aug 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Study type
- Interventional
- Enrollment
- 40 (estimated)
- First submitted
- 26 Aug 2025
- Start date
- 31 Mar 2026
- Primary completion date
- Dec 2027
- Lead sponsor
- St. Jude Children's Research Hospital
- Diseases
- Acute lymphoblastic leukaemia
- NCT number
- NCT07191119
What you commit to
- Study type: Interventional
- Planned participants: 40
- From 31 Mar 2026 to the primary completion date, Dec 2027
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Currently taking medication intended to treat neurocognitive impairment (i.e. stimulants) or medications prescribed for seizure management
- Medications and behavioral practices (white noise, night-time yoga, etc) are acceptable as long as the insomnia is persistent.
Other illness
- 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:
- 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)
- Seizures (Any in most recent 1 year
Other
- 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)
- Syncope (CTCAE \>2)
- Neuropathy (Cranial Nerves) (CTCAE \>2)
- Neuralgia (Cranial Nerves) (CTCAE \>2)
- Overt Cerebrovascular Accident (CTCAE \>2)
- Currently enrolled or participating in any other neurostimulation or neuromodulation ancillary research studies
Who the study is looking for
- 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
Age in the registry: 20 years to 50 years · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| St. Jude Children's Research Hospital Coordinator of this site? Confirm its status | Memphis | United States | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.