Transcutaneous Auricular Vagus Nerve Stimulation for Insomnia in Survivors of Childhood Acute Lymphoblastic Leukemia
{ "Transcutaneous Auricular Vagus Nerve Stimulation for Insomnia in Childhood ALL Survivors", "This study is looking at whether a device called Soterix tVNS can help adult survivors of childhood acute lymphoblastic leukemia (ALL) who have trouble sleeping (insomnia). You would use a non-invasive earbud device nightly for 20 minutes. Some participants will receive active stimulation, while others will receive a sham (inactive) stimulation. The study will last for 8 weeks and will check how well the device works to improve your sleep, reduce stress, and help with thinking skills. Researchers also want to see how easy it is for people to use the device regularly. To join, you need to be a survivor of childhood ALL, between 20 and 50 years old, and have moderate to severe insomnia.", "design": "This is an interventional study with about 40 participants. You would be randomly assigned to receive either active or inactive (sham) stimulation.", "commitments": "You would use the Soterix tVNS device nightly for 20 minutes. Your sleep quality, stress, and thinking skills will be measured at the start, after 2 weeks, and after 8 weeks.", "compensation": "Not stated in the trial record.", "follow_up": "Your sleep quality and insomnia scores will be measured at 2 weeks and 8 weeks. Side effects will be tracked weekly for 7 weeks.", }
- Study design
- Not specified.
- What's involved
- Not specified in the trial record.
- Compensation
- Not stated in the trial record.
- Follow-up
- Not specified.
AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.
Transcutaneous Auricular Vagus Nerve Stimulation for Insomnia in Survivors of Childhood Acute Lymphoblastic Leukemia
At a glance
Conditions
NCT07191119
Where you'd take part
This study runs at 1 site. They're the same protocol — you choose where, and that choice sets who your contact draft is addressed to.
St. Jude Children's Research Hospital
Memphis, Tennesseestudy coordinator listed
Recruiting
Sites open and close at different times, so the status above is per site — it can differ from the study's overall status.
Study leadership
- Justin E Tanner, PhD · PRINCIPAL_INVESTIGATOR · St. Jude Children's Research Hospital
Who to contact
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Inclusion
Exclusion
What this trial measures
- Mean Change in Subjective Sleep QualityBaseline, 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.
- Mean change in clinical insomnia scoreBaseline, 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.
- Occurrence of side effectsWeek 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.
- Adherence to intervention2-weeks, 8-weeks
Number of tVNS sessions performed. Descriptive statistics of adherence at 2 weeks and 8 weeks will be reported.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.