RightFit
RecruitingNot applicable

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

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

Who can join

As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.

Age
20 Years to 50 Years
Sex
All sexes
Healthy volunteers
Not accepted
Compensation
Not stated

Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.

What to expect

No one can promise a trial will help you personally — that is what the research is trying to find out.

What participation involves

Not stated in the study description — ask the study team about visits and procedures.

Compensation
Not stated
  • Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
  • Participants are monitored closely by the research team throughout the study.
  • Some participants may receive access to an investigational treatment, which is still being studied.
  • Your participation helps researchers learn whether this approach could help future patients.

About this study

In plain language

This study tests whether a nightly earbud device that stimulates a nerve through the skin can help adults with trouble sleeping. It is for adults ages 20–50 who survived childhood acute lymphoblastic leukemia (ALL), a blood cancer. Participants are assigned by chance to active or inactive stimulation for 2-week and 8-week periods to study device use, sleep, stress, and thinking skills.

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.

Compensation is read from the study's own description and may be missing — always confirm with the study team.

Eligibility

Who can join

  • You survived ALL and are enrolled in SJLIFE.
  • You were younger than 21 when diagnosed.
  • You are 20–50 years old when you join.
  • Your score on a test of trouble sleeping is at least 8, confirmed before you join.
  • You have home Wi-Fi and a smartphone.
  • You can speak and understand English.
  • You can and are willing to give consent to join.

Who can't join

  • The study leader decides you cannot understand the study details and requirements.
  • You are pregnant or plan to become pregnant.
  • You have an implanted electrical medical device, such as a pacemaker, or use a device for a sleep disorder, such as CPAP, which helps with breathing during sleep.
  • You take medicine for thinking or memory problems, such as stimulants, or medicine to control seizures.
  • You have had skin irritation or other problems during stimulation inside the ear.
  • You have a history of fainting, an abnormal heartbeat, blood vessel disease, or disease of the heart's arteries rated above grade 2 on a medical severity scale.
  • You currently have a nerve disorder or nerve pain involving nerves connected to the brain, a fast heartbeat, or a stroke rated above grade 2 on a medical severity scale, or have had any seizure in the past year.
  • You are enrolled in or taking part in another research study that stimulates or changes nerve activity.

Simplified for readability. The official criteria below are what the study team uses.

Official eligibility criteria

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 sites (1)

TN