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

ConditionsSurvivor of Childhood CancerInsomniaAcute Lymphoblastic Leukemia (ALL)
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age20-50
SponsorSt. Jude Children's Research Hospital

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

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

Trial design

Design model

Parallel

Treatments tested in this trial

  • 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.

Treatment groups

40 Participants
are divided into 2 treatment groups
Group A: Verum tVNS (Active Treatment)Experimental treatment 3 interventions
Group B: Sham tVNS (Placebo Comparator)Sham comparator 3 interventions

Trial outcomes

Primary outcomes

1

Mean Change in Subjective Sleep Quality

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.

Time frame
Baseline, 2-weeks, 8-weeks
2

Mean change in clinical insomnia score

Insomnia Severity Index (ISI, 0-28 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.

Time frame
Baseline, 2-weeks, 8-weeks
3

Occurrence of side effects

Patient Report of Incidence of Side Effects (PRISE). Descriptive statistics of the change between baseline and 2 and 8 weeks will be reported.

Time frame
Week 1, Week 2, Week 3, Week 4, Week 5, Week 6, Week 7
4

Adherence to intervention

Number of tVNS sessions performed. Descriptive statistics of adherence at 2 weeks and 8 weeks will be reported.

Time frame
2-weeks, 8-weeks

Secondary outcomes

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

St. Jude Children's Research Hospital

Lead sponsor

Source ClinicalTrials.gov
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