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| ID | Type | Description | Link |
|---|---|---|---|
| NCI-2025-08555 | Registry Identifier | NCI Clinical Trial Registration Program |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
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| 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Soterix tVNS device | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 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. | 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. | 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. | 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. | 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Justin E Tanner, PhD | Contact | 888-226-4343 | referralinfo@stjude.org |
| Name | Affiliation | Role |
|---|---|---|
| Justin E Tanner, PhD | St. Jude Children's Research Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| St. Jude Children's Research Hospital | Recruiting | Memphis | Tennessee | 38105 | United States |
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| Label | URL |
|---|---|
| St. Jude Children's Research Hospital | View source |
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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.
Data will be made available at the time of article publication.
Data will be provided to researchers following a formal request with the following information: full name of requestor, affiliation, data set requested, and timing of when data is needed. As an informational point, the lead statistician and study principal investigator will be informed that primary results datasets have been requested.
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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:
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| 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. |
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| Sleep Quality | Behavioral | Receive Pittsburgh Sleep Quality Index (PSQI); Insomnia Severity Index (ISI); Sleep diaries; Actigraphy via Fitbit Charge 5 |
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| Neurocognitive and mental health outcomes | Behavioral | Measured using CNS Vital Signs and DASS-21. |
|
| 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | Weekly means of daily measurements at baseline, at 2-weeks, and at 8-weeks |
| ID | Term |
|---|---|
| D007319 | Sleep Initiation and Maintenance Disorders |
| D054198 | Precursor Cell Lymphoblastic Leukemia-Lymphoma |
| ID | Term |
|---|---|
| D020919 | Sleep Disorders, Intrinsic |
| D020920 | Dyssomnias |
| D012893 | Sleep Wake Disorders |
| D009422 | Nervous System Diseases |
| D001523 | Mental Disorders |
| D007945 | Leukemia, Lymphoid |
| D007938 | Leukemia |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D006402 | Hematologic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D008232 | Lymphoproliferative Disorders |
| D008206 | Lymphatic Diseases |
| D007160 | Immunoproliferative Disorders |
| D007154 | Immune System Diseases |
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