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NCT07191119 · ClinicalTrials.gov registry record · NA
Transcutaneous Auricular Vagus Nerve Stimulation for Insomnia in Survivors of Childhood Acute Lymphoblastic Leukemia
A NA study of Insomnia and Acute Lymphoblastic Leukemia (ALL), sponsored by St. Jude Children's Research Hospital.
- Recruiting
- Registry status
- NA
- Development phase
- 40
- Enrollment target
- 1
- Study location
NCT07191119 is a NA study of Insomnia and Acute Lymphoblastic Leukemia (ALL) that is actively recruiting participants, run by St. Jude Children's Research Hospital. The registered enrollment target is 40 participants, below the 170-participant average among 151 other Insomnia trials with a reported enrollment target (76% lower). The trial reports 1 study location across 1 state.
The verdict
NCT07191119, a NA study of Insomnia and Acute Lymphoblastic Leukemia (ALL), is actively recruiting participants, sponsored by St. Jude Children's Research Hospital.
- RECRUITING
- Registry status
- NA
- Development phase
- 40 participants
- Enrollment target
- 1
- Study location
Study 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 Studied
Interventions
- DEVICE Soterix tVNS device
- DEVICE Soterix tVNS device (sham programmed)
- BEHAVIORAL Sleep Quality
- BEHAVIORAL Neurocognitive and mental health outcomes
Study Locations (1)
Tennessee
- St. Jude Children's Research Hospital - Memphis
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 40 participants |
| Start Date | 2026-03 |
| Est. Completion | 2029-12 |
| Phase | NA |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT07191119
The ClinicalTrials.gov registry entry for NCT07191119 describes a study currently listed as recruiting, categorized as NA. The registered enrollment target is 40 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 170-participant average among 151 other Insomnia trials with a reported enrollment target (76% lower). The listed sponsor is St. Jude Children's Research Hospital, which has 410 total studies on file at ClinicalTrials.gov.
The record links to 3 conditions, with Insomnia appearing as the primary indexed condition, and to 4 interventions - of which Soterix tVNS device is the first listed.
NCT07191119 reports 1 study location spanning 1 distinct geographic area - top geographies include Tennessee.
Frequently Asked Questions
What is clinical trial NCT07191119 about?
NCT07191119 is a clinical study titled "Transcutaneous Auricular Vagus Nerve Stimulation for Insomnia in Survivors of Childhood Acute Lymphoblastic Leukemia". 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 inact...
What is the current status of trial NCT07191119?
This trial is currently recruiting. It is a NA study. The enrollment target is 40 participants. The study started on 2026-03. Estimated completion is 2029-12.
What conditions does trial NCT07191119 study?
This clinical trial studies the following conditions: Insomnia, Acute Lymphoblastic Leukemia (ALL), Survivor of Childhood Cancer.
What interventions are being tested in trial NCT07191119?
The interventions under investigation include: Soterix tVNS device (DEVICE), Soterix tVNS device (sham programmed) (DEVICE), Sleep Quality (BEHAVIORAL), Neurocognitive and mental health outcomes (BEHAVIORAL).
Who is sponsoring clinical trial NCT07191119?
This trial is sponsored by St. Jude Children's Research Hospital, which has 410 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT07191119 being conducted?
This trial has 1 study location across Tennessee. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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