Transcutaneous Auricular Vagus Nerve Stimulation for Insomnia in Survivors of Childhood Acute Lymphoblastic Leukemia
NCT07191119, Not applicable, Recruiting, St. Jude Children's Research Hospital
Trial 10
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
| Field | Value | Source |
|---|---|---|
| Title | Transcutaneous Auricular Vagus Nerve Stimulation for Insomnia in Survivors of Childhood Acute Lymphoblastic Leukemia | ClinicalTrials.gov |
| NCT number | NCT07191119 | ClinicalTrials.gov |
| Status | Recruiting | ClinicalTrials.gov |
| Phases | Not applicable | ClinicalTrials.gov |
| Enrollment | 40 participants, estimated | ClinicalTrials.gov |
| Lead sponsor | St. Jude Children's Research Hospital | ClinicalTrials.gov |
| Conditions | Survivor of Childhood Cancer, Insomnia, Acute Lymphoblastic Leukemia (ALL) | ClinicalTrials.gov |
| Interventions | Soterix tVNS device, Soterix tVNS device (sham programmed), Sleep Quality, Neurocognitive and mental health outcomes | ClinicalTrials.gov |
| First posted | 2025-09-24 | ClinicalTrials.gov |
| Last updated | 2026-08-14 | ClinicalTrials.gov |
Registered outcomes 16
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description | Source |
|---|---|---|---|---|
| Primary | Mean Change in Subjective Sleep Quality | Baseline, 2-weeks, 8-weeks | 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. | ClinicalTrials.gov |
| Primary | Mean change in clinical insomnia score | Baseline, 2-weeks, 8-weeks | 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. | ClinicalTrials.gov |
| Primary | Occurrence of side effects | Week 1, Week 2, Week 3, Week 4, Week 5, Week 6, Week 7 | Patient Report of Incidence of Side Effects (PRISE). Descriptive statistics of the change between baseline and 2 and 8 weeks will be reported. | ClinicalTrials.gov |
| Primary | Adherence to intervention | 2-weeks, 8-weeks | Number of tVNS sessions performed. Descriptive statistics of adherence at 2 weeks and 8 weeks will be reported. | ClinicalTrials.gov |
| Primary | Mean change in Processing Speed (age adjusted z-score) | Baseline, 2-Weeks, 8-weeks | 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. | ClinicalTrials.gov |
| Primary | Mean change in Executive Function (age adjusted z-score) | Baseline, 2-Weeks, 8-weeks | 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. | ClinicalTrials.gov |
| Primary | Mean change in Simple Attention (age adjusted z-score) | Baseline, 2-Weeks, 8-weeks | 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. | ClinicalTrials.gov |
| Primary | Mean change in Reaction Time (age adjusted z-score) | Baseline, 2-Weeks, 8-weeks | 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. | ClinicalTrials.gov |
| Primary | Mean change in Sustained Attention (age adjusted z-score) | Baseline, 2-Weeks, 8-weeks | 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. | ClinicalTrials.gov |
| Primary | Mean change in Working Memory (age adjusted z-score) | Baseline, 2-Weeks, 8-weeks | 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. | ClinicalTrials.gov |
| Primary | Mean change in Complex Attention (age adjusted z-score) | Baseline, 2-Weeks, 8-weeks | 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. | ClinicalTrials.gov |
| Primary | Mean change in Cognitive Flexibility (age adjusted z-score) | Baseline, 2-Weeks, 8-weeks | 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. | ClinicalTrials.gov |
| Primary | Mean change in Depression, Anxiety, and Stress (scales) | Baseline, 2-Weeks, 8-weeks | 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. | ClinicalTrials.gov |
| Primary | Mean Change in Heart Rate Variability (ms) | Weekly means of daily measurements at baseline, at 2-weeks, and at 8-weeks | 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. | ClinicalTrials.gov |
| Primary | Mean Change in Sleep Onset Latency (minutes) | Weekly means of daily measurements at baseline, at 2-weeks, and at 8-weeks | 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. | ClinicalTrials.gov |
| Primary | Mean Change in Waking Events (count) | Weekly means of daily measurements at baseline, at 2-weeks, and at 8-weeks | 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. | ClinicalTrials.gov |
Outcomes 0
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as | Source |
|---|
Results by group 0
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units | Source |
|---|
Participant flow 0
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted | Source |
|---|
Adverse events 0
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events | Source |
|---|
Adverse event totals 0
The totals the trial posted for each group.
| Total | Group | Affected | At risk | Source |
|---|
Papers 0
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as | Source |
|---|
Grants 0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
| Project | Title | Principal investigators | Organization | Funder | Fiscal years | Source |
|---|
Trial comparisons 0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|
Tests 2
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
| Test | Named as | Source |
|---|---|---|
| Continuous Performance Test | Primary outcome | ConductCognition |
| Stroop Color-Word Test | Primary outcome | ConductCognition |
Source 5
| Field | Value | Source |
|---|---|---|
| Release | trials-2026-11-12-0.4.0 | ClinicalTrials.gov |
| Release manifest SHA-256 | 0f4a8d8c48aee2a7573ae0fa94ecbeab70c1adbe449bbc95c424bc7d3e97b9d4 | ClinicalTrials.gov |
| Registry capture | 2026-11-12 | ClinicalTrials.gov |
| Results copy, AACT | 2026-03-23 | ClinicalTrials.gov |
| NIH clinical studies file | 2026-11-13 | ClinicalTrials.gov |
Release trials-2026-11-12-0.4.0
ClinicalTrials.gov's posted results, through CTTI's AACT: ClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299 ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
ClinicalTrials.gov: none stated ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
NIH RePORTER's clinical studies and project files: Public domain (NIH RePORTER)