Survivor of Childhood CancerNCT07191119
Transcutaneous Auricular Vagus Nerve Stimulation for Insomnia in Survivors of Childhood Acute Lymphoblastic Leukemia
A study testing Soterix tVNS device, Sleep Quality and Neurocognitive and mental health outcomes in people with Survivor of Childhood Cancer and Insomnia, run by St. Jude Children's Research Hospital at 1 site in United States.
Trial summary
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). Read more about this study
- Who is it for?
- Ages 20 to 50 years
- Conditions the study is for
- Survivor of Childhood Cancer, Insomnia, Acute Lymphoblastic Leukemia (ALL)
- What is being tested?
- Soterix tVNS device, Sleep Quality and Neurocognitive and mental health outcomes
- Type of treatment
- Medical device, Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 40 participants
- Where
- 1 siteUnited States
- Study dates
- 31 Mar 2026to Dec 2029
- Phase
- Interventional
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 50 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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
Who cannot join
- 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)
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- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
St. Jude Children's Research Hospital
Memphis, Tennessee, 38105
Justin E Tanner, PhD, 888-226-4343, referralinfo@stjude.org
About this study
Official title: Feasibility and Efficacy of Transcutaneous Auricular Vagus Nerve Stimulation for Insomnia in Survivors of Childhood Acute Lymphoblastic Leukemia
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:
Read more
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.
Read the detailed description
Approximately 40 adult survivors of childhood ALL enrolled in the SJLIFE cohort will be recruited. Eligible participants must have moderate to severe insomnia (ISI ≥8). The intervention involves nightly use of a tVNS device for 20 minutes before sleep. Participants will be randomized to receive either active or sham stimulation. Feasibility will be assessed based on adherence rates, and efficacy will be estimated using subjective (PSQI, ISI) and objective (actigraphy, CNS Vital Signs) measures. Exploratory analyses will examine the onset of tVNS effects and the influence of genetic variants (BDNF rs6265, COMT rs4680) on treatment response.
- Being tested
- Soterix tVNS device, Soterix tVNS device (sham programmed), Sleep Quality, Neurocognitive and mental health outcomes
- Medical subject headings
- Sleep Initiation and Maintenance Disorders, Precursor Cell Lymphoblastic Leukemia-Lymphoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Soterix tVNS deviceDevice
Also called tVNS
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)Device
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 QualityBehavioural
Receive Pittsburgh Sleep Quality Index (PSQI); Insomnia Severity Index (ISI); Sleep diaries; Actigraphy via Fitbit Charge 5
Neurocognitive and mental health outcomesBehavioural
Measured using CNS Vital Signs and DASS-21.
| Study group | Role | What they receive |
|---|---|---|
| Verum tVNS (Active Treatment) | Experimental | 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. Receives: Device: Soterix tVNS device; Behavioral: Sleep Quality; Behavioral: Neurocognitive and mental health outcomes |
| Sham tVNS (Placebo Comparator) | Sham 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. Receives: Device: Soterix tVNS device (sham programmed); Behavioral: Sleep Quality; Behavioral: Neurocognitive and mental health outcomes |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mean Change in Subjective Sleep Quality
Pittsburgh Sleep Quality Index (PSQI, 0-57 points). Descriptive statistics of the difference between experiment arms of the change between baseline and 2 weeks, and baseline and 8 weeks will be reported.
Measured: Baseline, 2-weeks, 8-weeks
Mean change in clinical insomnia score
Insomnia Severity Index (ISI, 0-28 points). Descriptive statistics of the difference between experiment arms of the change between baseline and 2 weeks, and baseline and 8 weeks will be reported.
Measured: Baseline, 2-weeks, 8-weeks
Occurrence of side effects
Patient Report of Incidence of Side Effects (PRISE). Descriptive statistics of the change between baseline and 2 and 8 weeks will be reported.
Measured: Week 1, Week 2, Week 3, Week 4, Week 5, Week 6, Week 7
Adherence to intervention
Number of tVNS sessions performed. Descriptive statistics of adherence at 2 weeks and 8 weeks will be reported.
Measured: 2-weeks, 8-weeks
Mean change in Processing Speed (age adjusted z-score)
Symbol Digit Coding Test as the difference between correct responses and errors. Descriptive statistics of the difference between experiment arms of the change between baseline and 2 weeks, and baseline and 8 weeks will be reported.
Measured: Baseline, 2-Weeks, 8-weeks
Mean change in Executive Function (age adjusted z-score)
Shifting Attention Task as the difference between correct responses and errors. Descriptive statistics of the difference between experiment arms of the change between baseline and 2 weeks, and baseline and 8 weeks will be reported.
Measured: Baseline, 2-Weeks, 8-weeks
Mean change in Simple Attention (age adjusted z-score)
Continuous Performance Test as the difference between correct responses and commission errors. Descriptive statistics of the difference between experiment arms of the change between baseline and 2 weeks, and baseline and 8 weeks will be reported.
Measured: Baseline, 2-Weeks, 8-weeks
Mean change in Reaction Time (age adjusted z-score)
Stroop Test as the average of reaction times in the complex and default trials. Descriptive statistics of the difference between experiment arms of the change between baseline and 2 weeks, and baseline and 8 weeks will be reported.
Measured: Baseline, 2-Weeks, 8-weeks
Mean change in Sustained Attention (age adjusted z-score)
Four-Part Continuous Performance Test as the difference between correct responses and incorrect responses in Part 2, 3, and 4. Descriptive statistics of the difference between experiment arms of the change between baseline and 2 weeks, and baseline and 8 weeks will be reported.
Measured: Baseline, 2-Weeks, 8-weeks
Mean change in Working Memory (age adjusted z-score)
Four-Part Continuous Performance Test as the difference between correct responses and incorrect responses in Part 4 only. Descriptive statistics of the difference between experiment arms of the change between baseline and 2 weeks, and baseline and 8 weeks will be reported.
Measured: Baseline, 2-Weeks, 8-weeks
Mean change in Complex Attention (age adjusted z-score)
Evaluated with the Stroop Test (ST), Shifting Attention Test (SAT), and Continuous Performance Test (CPT) as the sum of ST commission errors, SAT errors, CPT commission errors, and CPT omission errors. Descriptive statistics of the difference between experiment arms of the change between baseline and 2 weeks, and baseline and 8 weeks will be reported.
Measured: Baseline, 2-Weeks, 8-weeks
Mean change in Cognitive Flexibility (age adjusted z-score)
Evaluated with the Stroop Test (ST) and Shifting Attention Test (SAT) as the difference between SAT correct responses and the sum of the SAT errors and ST commission errors. Descriptive statistics of the difference between experiment arms of the change between baseline and 2 weeks, and baseline and 8 weeks will be reported.
Measured: Baseline, 2-Weeks, 8-weeks
Mean change in Depression, Anxiety, and Stress (scales)
Evaluated with Depression Anxiety Stress Scale Short Form (DASS SF-21). Descriptive statistics of the difference between experiment arms of the change between baseline and 2 weeks, and baseline and 8 weeks will be reported. DASS SF-21 are reported as population z-scores and categorized into five severity ranges: normal, mild, moderately severe, and extremely severe. The severity levels, higher percentiles being more severe, are determined by z-scores from the DASS manual.
Measured: Baseline, 2-Weeks, 8-weeks
Mean Change in Heart Rate Variability (ms)
Root Mean Square Successive Difference (RMSSD) of heart rate variability. Descriptive statistics of the difference between experiment arms of the change between baseline and 2 weeks, and baseline and 8 weeks will be reported.
Measured: Weekly means of daily measurements at baseline, at 2-weeks, and at 8-weeks
Mean Change in Sleep Onset Latency (minutes)
Sleep Onset Latency (time in bed before sleep). Descriptive statistics of the difference between experiment arms of the change between baseline and 2 weeks, and baseline and 8 weeks will be reported.
Measured: Weekly means of daily measurements at baseline, at 2-weeks, and at 8-weeks
Mean Change in Waking Events (count)
Number of Awakenings. Descriptive statistics of the difference between experiment arms of the change between baseline and 2 weeks, and baseline and 8 weeks will be reported.
Measured: Weekly means of daily measurements at baseline, at 2-weeks, and at 8-weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Sep 2025
- Study start31 Mar 2026
- Primary completionDec 2027 (estimated)
- Study completionDec 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Survivor of Childhood CancerStudies of the same condition, open and under way.
- More trials run by St. Jude Children's Research HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Device feasibility
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- A blinded, randomized sham/placebo-controlled pilot study with self-administered tVNS. 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.
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- St. Jude Children's Research Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Justin E Tanner, PhD, Principal investigator, St. Jude Children's Research Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07191119
- Sponsor's protocol ID
- FANSI
- Other IDs
- NCI-2025-08555
- Status last verified
- Aug 2026
- First submitted
- 26 Aug 2025
- Last updated
- 14 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- Yes: Individual participant de-identified datasets containing the variables analyzed in the published article will be made available (related to the study primary or secondary objectives contained in the publication). Supporting documents such as the protocol, statistical analyses plan, and informed consent are available through the CTG website for the specific study. Data used to generate the published article will be made available at the time of article publication. Investigators who seek access to individual level de-identified data will contact the computing team in the Department of Biostatistics (ClinTrialDataRequest@stjude.org) who will respond to the data request.