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.
Age range
20 Years – 50 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
Mean Change in Subjective Sleep Quality
Timeframe: Baseline, 2-weeks, 8-weeks
Mean change in clinical insomnia score
Timeframe: Baseline, 2-weeks, 8-weeks
Occurrence of side effects
Timeframe: Week 1, Week 2, Week 3, Week 4, Week 5, Week 6, Week 7
Adherence to intervention
Timeframe: 2-weeks, 8-weeks
Mean change in Processing Speed (age adjusted z-score)
Timeframe: Baseline, 2-Weeks, 8-weeks
Mean change in Executive Function (age adjusted z-score)
Timeframe: Baseline, 2-Weeks, 8-weeks
Mean change in Simple Attention (age adjusted z-score)
Timeframe: Baseline, 2-Weeks, 8-weeks
Mean change in Reaction Time (age adjusted z-score)
Timeframe: Baseline, 2-Weeks, 8-weeks
Mean change in Sustained Attention (age adjusted z-score)
Timeframe: Baseline, 2-Weeks, 8-weeks
Mean change in Working Memory (age adjusted z-score)
Timeframe: Baseline, 2-Weeks, 8-weeks
Mean change in Complex Attention (age adjusted z-score)
Timeframe: Baseline, 2-Weeks, 8-weeks
Mean change in Cognitive Flexibility (age adjusted z-score)
Timeframe: Baseline, 2-Weeks, 8-weeks
Mean change in Depression, Anxiety, and Stress (scales)
Timeframe: Baseline, 2-Weeks, 8-weeks
Mean Change in Heart Rate Variability (ms)
Timeframe: Weekly means of daily measurements at baseline, at 2-weeks, and at 8-weeks
Mean Change in Sleep Onset Latency (minutes)
Timeframe: Weekly means of daily measurements at baseline, at 2-weeks, and at 8-weeks
Mean Change in Waking Events (count)
Timeframe: Weekly means of daily measurements at baseline, at 2-weeks, and at 8-weeks