Noninvasive ear vagus nerve stimulation for insomnia in adult survivors of childhood ALL

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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

Where it's running

• 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

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.