Vagus Nerve Stimulation for Insomnia

Age: 18 - 65

Sex: Any

Trial Phase: Academic

Sponsor: St. Jude Children's Research Hospital

Must not be taking: Stimulants, Seizure medications

Disqualifiers: Pregnancy, Pacemaker, Seizures, Cardiac dysrhythmia, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

Duration: 10 weeks

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores whether a special earbud device that stimulates the vagus nerve (transcutaneous auricular vagus nerve stimulation) can improve sleep in individuals who survived childhood acute lymphoblastic leukemia (ALL) and now experience moderate to severe insomnia. Participants will use the device nightly for varying durations to assess its impact on sleep, stress levels, and brain function. The trial will compare the real device to a placebo version to evaluate its effectiveness. It suits ALL survivors with ongoing insomnia who have access to Wi-Fi and a smartphone. As an unphased trial, this study offers an opportunity to contribute to innovative research that could enhance sleep for ALL survivors.

Will I have to stop taking my current medications?

You may need to stop taking certain medications, especially if they are intended to treat neurocognitive impairment or seizures, as these are part of the exclusion criteria for the trial.

What prior data suggests that this device is safe for treating insomnia?

Research shows that using a device to gently stimulate a nerve in the ear, known as transcutaneous auricular vagus nerve stimulation (tVNS), is generally safe and well-tolerated. Studies with individuals who have trouble sleeping have found tVNS to be an effective and non-invasive method for managing sleep problems. No major reports of serious side effects have emerged, making it a promising option for those with sleep issues. Participants in these studies typically handle the treatment well and experience little discomfort. This safety record suggests that tVNS is a good option for improving sleep quality without significant risk. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Unlike standard insomnia treatments like medication or cognitive behavioral therapy, transcutaneous auricular vagus nerve stimulation (tVNS) offers a non-invasive approach that targets the vagus nerve through the skin. This method is unique because it uses the Soterix device to deliver electrical stimulation to the ear, which is thought to modulate brain activity and improve sleep quality. Researchers are excited about tVNS because it could provide a safe, side-effect-free alternative to traditional insomnia treatments, offering a new hope for those who struggle with sleep without relying on drugs. Additionally, the potential for nightly home use makes it a convenient option for patients.

What evidence suggests that transcutaneous auricular vagus nerve stimulation is effective for treating insomnia in ALL survivors?

Research has shown that transcutaneous auricular vagus nerve stimulation (tVNS) can greatly improve sleep quality and reduce insomnia severity. In this trial, participants will receive either active tVNS or a sham treatment. Studies found that those using tVNS slept better and experienced less severe insomnia compared to those receiving a fake treatment. Specifically, the Pittsburgh Sleep Quality Index (PSQI) demonstrated significant improvements with tVNS. Participants who received the real treatment also reported a better overall quality of life. These findings suggest that tVNS is a promising option for treating insomnia. ^{1 3 4 5 6}

Who Is on the Research Team?

Justin E Tanner, PhD

Principal Investigator

St. Jude Children's Research Hospital

Are You a Good Fit for This Trial?

This trial is for adult survivors of childhood acute lymphoblastic leukemia who are experiencing moderate to severe insomnia. Participants should be willing to use a non-invasive earbud device nightly.

Inclusion Criteria

Enrolled on SJLIFE

Insomnia Severity Index >=8 (Proxy >=8) confirmed prior to enrollment

Access to home Wi-Fi and Smartphone

Exclusion Criteria

Presence of implanted electrical medical devices (i.e. pacemaker)

History of skin irritation or other issues during stimulation of inner ear

Currently utilizing a technological intervention for a sleep disorder (e.g. CPAP)

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive nightly transcutaneous auricular vagus nerve stimulation (tVNS) for 20 minutes using either active or sham stimulation over two periods: 2 weeks and 8 weeks.

10 weeks

Weekly assessments

Follow-up

Participants are monitored for safety and effectiveness after treatment, including assessments of sleep quality, stress, and neurocognitive function.

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Transcutaneous Auricular Vagus Nerve Stimulation

Trial Overview The study tests if transcutaneous auricular vagus nerve stimulation (tVNS) can improve sleep quality, reduce stress, and enhance neurocognitive function in participants. It involves active or sham tVNS over two periods: 2 weeks and 8 weeks.

How Is the Trial Designed?

Group I: Verum tVNS (Active Treatment) Experimental Treatment 3 Interventions

Participants randomized to receive 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.

Group II: Sham tVNS (Placebo Comparator) Placebo Group 3 Interventions

Participants randomized to receive sham stimulation using the same Soterix device, but with no active electrical stimulation. The procedure mimics the verum condition in duration and setup.

Who Is Running the Clinical Trial?

St. Jude Children's Research Hospital

Lead Sponsor

Trials

451

Recruited

5,326,000+

Citations

1. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/40398066/

Transcutaneous auricular vagus nerve stimulation (taVNS ... Conclusions: taVNS significantly improved sleep quality, insomnia severity, and overall quality of life compared to sham. These findings establish taVNS as a ...

2. jamanetwork.com jamanetwork.com/journals/jamanetworkopen/fullarticle/2828072

Transcutaneous Auricular Vagus Nerve Stimulation for ... In this randomized clinical trial, taVNS significantly reduced insomnia severity. Clinically meaningful enhancements in PSQI scores were observed compared with ...

3. sciencedirect.com sciencedirect.com/science/article/abs/pii/S1389945725002540

Transcutaneous auricular vagus nerve stimulation (taVNS ... taVNS significantly improved sleep quality, insomnia severity, and overall quality of life compared to sham. These findings establish taVNS as a safe and ...

4. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/40323248/

Transcutaneous Auricular Vagus Nerve Stimulation in ... The pooled analysis showed statistically significant improvements in sleep quality and insomnia severity, as measured by PSQI (MD = -3.60; 95% ...

5. frontiersin.org frontiersin.org/journals/neuroscience/articles/10.3389/fnins.2021.609640/full

Brain Functional Mechanisms Determining the Efficacy of ... Transcutaneous auricular vagus nerve stimulation (taVNS) has been reported to be effective in the treatment of primary insomnia (PI); however, ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12174914/

Transcutaneous Auricular Vagus Nerve Stimulation (taVNS ... Transcutaneous auricular vagus nerve stimulation (taVNS) is a safe and highly tolerated method, and it might be an alternative therapy for patients with ...