Recruiting

tVNS

Sponsor:

St. Jude Children's Research Hospital

Code:

NCT07191119

Conditions

Survivor of Childhood Cancer

Insomnia

Acute Lymphoblastic Leukemia (ALL)

Eligibility Criteria

Sex: All

Age: 20 - 50

Healthy Volunteers: Not accepted

Interventions

Soterix tVNS device

Soterix tVNS device (sham programmed)

Sleep Quality

Neurocognitive and mental health outcomes

Study Details

Brief 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). 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.

Conditions

Survivor of Childhood Cancer

Insomnia

Acute Lymphoblastic Leukemia (ALL)

Study ID

NCT07191119

Start date

Mar 31, 2026

Status verified date

Aug, 2026

Completion date

Dec, 2029

Anticipated

Primary completion date

Dec, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 20 - 50

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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)
  • 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

Study Design

Enrollment

40 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Device Feasibility

Interventions and Outcome Measures

Arms

experimental: Verum tVNS (Active Treatment)

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.

sham comparator: Sham tVNS (Placebo 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.

Interventions

Soterix tVNS 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.

Soterix tVNS device (sham programmed)

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 Quality

Receive Pittsburgh Sleep Quality Index (PSQI); Insomnia Severity Index (ISI); Sleep diaries; Actigraphy via Fitbit Charge 5

Neurocognitive and mental health outcomes

Measured using CNS Vital Signs and DASS-21.

Primary outcome measure

  • Mean Change in Subjective Sleep Quality [ Time Frame: Baseline, 2-weeks, 8-weeks ]
  • Mean change in clinical insomnia score [ Time Frame: Baseline, 2-weeks, 8-weeks ]
  • Occurrence of side effects [ Time Frame: Week 1, Week 2, Week 3, Week 4, Week 5, Week 6, Week 7 ]
  • Adherence to intervention [ Time Frame: 2-weeks, 8-weeks ]
  • Mean change in Processing Speed (age adjusted z-score) [ Time Frame: Baseline, 2-Weeks, 8-weeks ]
  • Mean change in Executive Function (age adjusted z-score) [ Time Frame: Baseline, 2-Weeks, 8-weeks ]
  • Mean change in Simple Attention (age adjusted z-score) [ Time Frame: Baseline, 2-Weeks, 8-weeks ]
  • Mean change in Reaction Time (age adjusted z-score) [ Time Frame: Baseline, 2-Weeks, 8-weeks ]
  • Mean change in Sustained Attention (age adjusted z-score) [ Time Frame: Baseline, 2-Weeks, 8-weeks ]
  • Mean change in Working Memory (age adjusted z-score) [ Time Frame: Baseline, 2-Weeks, 8-weeks ]
  • Mean change in Complex Attention (age adjusted z-score) [ Time Frame: Baseline, 2-Weeks, 8-weeks ]
  • Mean change in Cognitive Flexibility (age adjusted z-score) [ Time Frame: Baseline, 2-Weeks, 8-weeks ]
  • Mean change in Depression, Anxiety, and Stress (scales) [ Time Frame: Baseline, 2-Weeks, 8-weeks ]
  • Mean Change in Heart Rate Variability (ms) [ Time Frame: Weekly means of daily measurements at baseline, at 2-weeks, and at 8-weeks ]
  • Mean Change in Sleep Onset Latency (minutes) [ Time Frame: Weekly means of daily measurements at baseline, at 2-weeks, and at 8-weeks ]
  • Mean Change in Waking Events (count) [ Time Frame: Weekly means of daily measurements at baseline, at 2-weeks, and at 8-weeks ]

Central Contacts and Locations

Central contacts

Justin E Tanner, PhD

888-226-4343referralinfo@stjude.org

Locations

St. Jude Children's Research Hospital

Recruiting

Memphis, Tennessee, United States, 38105

Contacts

Justin E Tanner, PhD

888-226-4343referralinfo@stjude.org

More Information

Sponsor

St. Jude Children's Research Hospital

Last update posted

Aug 14, 2026

Last verified

Aug, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-08. This information was provided to ClinicalTrials.gov by St. Jude Children's Research Hospital on 2026-08-14.