Non-invasive Nerve Stimulation for Sleep Difficulties in PTSD

(NINS Trial)

Overseen By Richard B Berry, MD

Age: 18 - 65

Sex: Any

Trial Phase: Academic

Sponsor: VA Office of Research and Development

Disqualifiers: Neurological conditions, Schizophrenia, Untreated sleep apnea, others

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

Compensation: Varies

Number of Visits: 1

Duration: 1 night

104 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores a new method to help people with PTSD (Post-Traumatic Stress Disorder) who struggle with sleep. It tests a non-invasive technique using gentle electrical stimulation on the ear to determine if it can enhance sleep by affecting brain function. The trial consists of two parts: one where the stimulation is applied for a set duration and another where it is briefly applied and then stopped. Individuals with ongoing PTSD symptoms who can speak English might be suitable candidates for this study. As an unphased trial, this study provides a unique opportunity to contribute to innovative research that could improve sleep for those with PTSD.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the study team or your doctor.

What prior data suggests that this non-invasive nerve stimulation is safe for improving sleep in PTSD?

Research shows that non-invasive nerve stimulation is generally well-tolerated. For instance, a similar method, vagus nerve stimulation, has proven safe and beneficial for individuals with PTSD (Post-Traumatic Stress Disorder). In these studies, participants experienced no serious side effects, and many reported improvements in PTSD symptoms.

Additionally, research on nerve stimulation for sleep issues, such as insomnia, has not identified major negative effects. This indicates the treatment is relatively safe for individuals with sleep disorders, including those related to PTSD.

Although specific results from this trial are not yet available, existing research provides some confidence in the safety of non-invasive nerve stimulation. Individual experiences may vary, so discussing any concerns with the study team is advisable. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about non-invasive nerve stimulation for sleep difficulties in PTSD because it offers a novel approach compared to traditional treatments like therapy and medication. This method involves delivering electrical stimulation to a specific spot on the ear, which is quite different from the usual medications or cognitive-behavioral therapies. One of its unique features is that it's non-invasive, meaning it doesn't require surgery or medications, potentially reducing side effects. Additionally, the sham comparator approach helps ensure the treatment's effects are real, not just placebo. This could potentially lead to a quicker, safer, and less intrusive way to improve sleep for those with PTSD.

What evidence suggests that non-invasive nerve stimulation is effective for sleep difficulties in PTSD?

Research has shown that non-invasive nerve stimulation can help with sleep problems, particularly for individuals with PTSD (Post Traumatic Stress Disorder). Studies have found that stimulating certain nerves can alter brain activity, leading to improved sleep. In this trial, participants will receive either non-invasive nerve stimulation or a sham comparator. Treatments such as repetitive transcranial magnetic stimulation (rTMS) have successfully reduced PTSD symptoms, which often include sleep issues. A review found these treatments to be very effective for many people. This suggests that non-invasive nerve stimulation could be a promising method to improve sleep for those with PTSD. ^{1 2 3 6 7}

Who Is on the Research Team?

John B. Williamson, PhD

Principal Investigator

North Florida/South Georgia Veterans Health System, Gainesville, FL

Are You a Good Fit for This Trial?

This trial is for individuals with PTSD, possibly with mild traumatic brain injury (mTBI), who struggle to sleep and are fluent in English. It's not suitable for those with neurological issues unrelated to mTBI, severe psychiatric conditions like schizophrenia, untreated sleep apnea, major sensory deficits, current substance abuse or recent drug use.

Inclusion Criteria

English fluency

I have PTSD with or without a mild brain injury, and I'm currently experiencing significant symptoms.

Exclusion Criteria

Current drug or alcohol abuse

Drug abuse within the last two months will result in exclusion or delay

I have no neurological conditions affecting the study other than mild traumatic brain injury.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive non-invasive nerve stimulation at the ear to improve sleep quality

1 night

1 visit (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• non-invasive nerve stimulation

Trial Overview The study is examining the effects of non-invasive nerve stimulation on two different areas that might improve brain function and help people with PTSD sleep better. The goal is to find more effective treatments for sleep difficulties associated with PTSD.

How Is the Trial Designed?

Group I: non-invasive nerve stimulation a Experimental Treatment 1 Intervention

Electrical stimulation will be delivered to a location at the ear.

Group II: non-invasive nerve stimulation b Placebo Group 1 Intervention

Electrical stimulation will be delivered to a location at the ear for two minutes and rolled off to zero slowly.

Who Is Running the Clinical Trial?

VA Office of Research and Development

Lead Sponsor

Trials

1,691

Recruited

3,759,000+

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT04021537

NCT04021537 | Non-invasive Nerve Stimulation and Sleep Sleep difficulties are common in disorders such as Post Traumatic Stress Disorder. Current treatments for sleep difficulties are not effective for everyone.

2. clinicaltrials.gov clinicaltrials.gov/study/NCT03170440

Non-invasive Nerve Stimulation for PTSD and Sleep | ... Most clinical studies have one primary outcome measure, but some have more than one. ... The main reason for the clinical trial. The types of primary purpose are: ...

3. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12089259/

The Latest Advances in Non-Invasive Neurostimulation for ... We reviewed the latest research on non-invasive neurostimulation techniques for insomnia in recent years, mainly focusing on virtual reality, biofeedback, ...

4. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC7256039/

Non-invasive brain stimulation for posttraumatic stress disorder Results revealed that rTMS is an effective treatment to reduce core symptoms of PTSD with a large effect size (Hedges' g = −0.975) and ...

5. sciencedirect.com sciencedirect.com/science/article/abs/pii/S0887618524000884

Review Neuromodulation treatments for post-traumatic ... This meta-analysis newly highlighted iTBS as a promising time-efficient treatment option and supported dual-tDCS, HF-rTMS, and LF-rTMS as effective treatment ...

6. sciencedirect.com sciencedirect.com/science/article/pii/S1935861X25000609

Vagus nerve stimulation therapy for treatment-resistant PTSD VNS therapy was safe and feasible to deliver. •. After therapy, all participants no longer met the criteria for PTSD diagnosis. •.

7. academic.oup.com academic.oup.com/sleep/article/48/8/zsaf152/8158932

Optimizing transcutaneous vagus nerve stimulation ... Preliminary evidence of transcutaneous vagus nerve stimulation effects on sleep in veterans with post-traumatic stress disorder . J Sleep Res.