Transcutaneous Auricular Vagus Nerve Stimulation for Insomnia in Survivors of Childhood Acute Lymphoblastic Leukemia

Part of paid clinical trials in Memphis, Tennessee.

Sponsor
St. Jude Children's Research Hospital
Study ID
NCT07191119
Status
Recruiting
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Conditions

  • Acute Lymphoblastic Leukemia (ALL)
  • Insomnia
  • Survivor of Childhood Cancer

Eligibility Criteria

Sex
ALL
Age
20 Years - 50 Years
Healthy Volunteers
Not accepted

Interventions

  • 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.
  • 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.
  • Sleep Quality — BEHAVIORAL
    Receive Pittsburgh Sleep Quality Index (PSQI); Insomnia Severity Index (ISI); Sleep diaries; Actigraphy via Fitbit Charge 5
  • Neurocognitive and mental health outcomes — BEHAVIORAL
    Measured using CNS Vital Signs and DASS-21.

Study Details

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.

Key Dates

Start date
Mar 31, 2026
Status verified
Apr 2026
Primary completion
Dec 31, 2027
Completion
Dec 31, 2029

Study Design

Enrollment
40 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
DEVICE_FEASIBILITY

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.

Primary Outcome Measure

Mean Change in Subjective Sleep Quality [ Time Frame: Baseline, 2-weeks, 8-weeks ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
St. Jude Children's Research HospitalMemphisTennessee38105
Justin E Tanner, PhD
[email protected]
888-226-4343

Find similar trials in Memphis, TN

By condition
Insomnia
By specialty
Mental healthSleep medicine
By research site
St. Jude Children's Research Hospital· Memphis, TN

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