Skip to Main Content
Recruiting

FANSI: tVNS for Sleep in Adult ALL Survivors

About this study

Many people who had acute lymphoblastic leukemia (ALL) as children have problems sleeping when they are adults. Trouble sleeping is called insomnia. It means a person cannot fall asleep easily or wakes up a lot at night. Insomnia can make daily life hard. 

Researchers want to see if a gentle, safe method called transcutaneous auricular vagus nerve stimulation, or tVNS, can help. tVNS uses a small device that sends tiny signals to a nerve in the ear. These signals may help the brain relax and help people sleep better without strong medicines.

In this study, some people will use the real tVNS device every night for 20 minutes before sleep. Others will use a fake device that looks the same but does not send signals. People will be put into groups at random, like flipping a coin.

Researchers will see if people can use the device correctly and check how it affects sleep. People in the study will keep sleep diaries, complete sleep questionnaires, and wear smart watches that track movement during sleep. Researchers will check stress and thinking skills with simple tests.

The main goal is to find out if using tVNS is safe and possible for adults who had ALL as children. The study will also give an idea of how well tVNS might help sleep. 

If the results look good, future studies could test tVNS in more people. This would help researchers know for sure if this method can improve sleep and overall health over time.

Eligibility overview

  • Survivor of childhood acute lymphoblastic leukemia
  • Age 20–50 
  • Has self-reported moderate-to-severe insomnia
  • Enrolled in SJLIFE study
  • Able and willing to use the tVNS device nightly
  • Speaks and understands English
  • No severe physical or mental conditions that would interfere with the study

The above information is intended to provide only a basic description about a research protocol that may be currently active at St. Jude. The details made available here may not be the most up-to-date information on protocols used by St. Jude. To receive full details about a protocol and its status and or use at St. Jude, a physician must contact St. Jude directly.

Overview

Full title:

FANSI: Feasibility and Efficacy of Transcutaneous Auricular Vagus Nerve Stimulation for Insomnia in Survivors of Childhood Acute Lymphoblastic Leukemia

Study goal:

To study transcutaneous auricular vagus nerve stimulation (tVNS) for insomnia in adult survivors of childhood acute lymphoblastic leukemia

Age:

20-50 years

Clinical trial categories:

Acute Lymphoblastic Leukemia (ALL)

For physicians and researchers

Patients accepted to St. Jude must be referred by a physician or other qualified medical professional. Learn how St. Jude can partner with you to care for your patient.

 

Learn more