Non-invasive Nerve Stimulation for Sleep Difficulties in PTSD
(NINS Trial)

Recruiting in Palo Alto (17 mi)

Overseen byJohn B. Williamson, PhD

Age: 18 - 65

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 3

Recruiting

Sponsor: VA Office of Research and Development

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

No Placebo Group

Pivotal Trial (Near Approval)

Prior Safety Data

Trial Summary

What is the purpose of this trial?

People often have difficulty sleeping. Reasons are many. But, difficulty falling and staying asleep are common issues. Sleep difficulties are common in disorders such as Post Traumatic Stress Disorder. Current treatments for sleep difficulties are not effective for everyone. Better treatments are needed. In this study, the investigators are testing two nerve stimulation locations that may impact brain function in such a way that sleep is improved.

Research Team

John B. Williamson, PhD

Principal Investigator

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

Eligibility Criteria

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.

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Trial Timeline

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

Treatment Details

Interventions

non-invasive nerve stimulation (Behavioural Intervention)

Trial OverviewThe 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.

Participant Groups

2Treatment groups

Experimental Treatment

Active Control

Group I: non-invasive nerve stimulation aExperimental Treatment1 Intervention

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

Group II: non-invasive nerve stimulation bActive Control1 Intervention

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