Noninvasive ear vagus nerve stimulation for insomnia in adult survivors of childhood ALL
Feasibility and Efficacy of Transcutaneous Auricular Vagus Nerve Stimulation for Insomnia in Survivors of Childhood Acute Lymphoblastic Leukemia
This tests whether nightly noninvasive ear vagus nerve stimulation can improve sleep in adult survivors of childhood acute lymphoblastic leukemia who have moderate to severe insomnia.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 40 (estimated) |
| Ages | 20 Years to 50 Years |
| Sex | All |
| Sponsor | St. Jude Children's Research Hospital Academic / other |
| Locations | 1 site (Memphis, Tennessee) |
| Trial ID | NCT07191119 on ClinicalTrials.gov |
What this trial studies
About 40 adult survivors of childhood ALL enrolled in the St. Jude Lifetime Cohort will be randomized to active or sham transcutaneous auricular vagus nerve stimulation (tVNS) delivered nightly via an earbud device for 20 minutes before sleep. Participants will use the device over two intervention epochs (short-term and longer-term, including a planned 2-week and an 8-week period) while wearing actigraphy and completing sleep and cognitive questionnaires and tests. The trial will measure feasibility by adherence rates and estimate effects on subjective sleep (PSQI, ISI), objective sleep measures (actigraphy), stress, and neurocognitive performance (CNS Vital Signs). Exploratory analyses will look at time course of effect and whether common genetic variants (BDNF rs6265, COMT rs4680) influence response.
Who should consider this trial
Good fit: Adult survivors of childhood acute lymphoblastic leukemia aged 20–50 who are enrolled in the SJLIFE cohort and have moderate to severe insomnia (Insomnia Severity Index ≥8), smartphone access, and home Wi‑Fi are the intended participants.
Not a fit: Patients with implanted electrical devices, active use of CPAP or other technological sleep treatments, current seizure or stimulant medications, pregnancy, significant ear skin irritation, or inability to follow English-language procedures are unlikely to benefit or be eligible.
Why it matters
Potential benefit: If successful, this could provide a non-drug, at-home option to reduce insomnia and related stress or cognitive complaints in adult survivors of childhood ALL.
How similar studies have performed: Small early trials of transcutaneous vagus nerve stimulation have shown promising effects on sleep, mood, and autonomic measures, but randomized data specifically in ALL survivors with insomnia are limited.
Eligibility criteria
Show full inclusion / exclusion criteria
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) * 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
Where this trial is running
Memphis, Tennessee
- St. Jude Children's Research Hospital — Memphis, Tennessee, United States (Recruiting)
Study contacts
- Principal investigator: Justin E Tanner, PhD — St. Jude Children's Research Hospital
- Study coordinator: Justin E Tanner, PhD
- Email: referralinfo@stjude.org
- Phone: 888-226-4343
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.