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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: Recruiting NA study of Insomnia and Acute Lymphoblastic Leukemia (ALL), sponsored by St. Jude Children's Research Hospital.

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. According to ClinicalTrials.gov, the official US trial registry.

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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.

Primary Outcome

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.

Conditions Studied

Insomnia Acute Lymphoblastic Leukemia (ALL) Survivor of Childhood Cancer

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

FieldValue
Enrollment Target 40 participants
Start Date 2026-03
Est. Completion 2029-12
Phase NA
St. Jude Children's Research Hospital

410 total trials

What NCT07191119 shows while recruiting

NCT07191119 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 40 participants, a relatively small participant target, below the 170-participant average among 151 other Insomnia trials with a reported enrollment target (76% lower).

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 a single indexed study location in 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.

Learn More About Clinical Trials

Similar trials for Insomnia

Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.

Where NCT07191119's enrollment target sits among peer trials

40 115th of 151 higher than 34 of 151 other Insomnia trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Insomnia trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.

Source ClinicalTrials.gov registry export · 2026-08-08

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More recruiting context for NCT07191119

Source: ClinicalTrials.gov NCT07191119, the US trial registry maintained by the National Library of Medicine. NCT07191119 (small enrollment · single site footprint · recruiting) retrieved and formatted by PlainTrial, see methodology.