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Behavioural Intervention

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

Phase 2 & 3
Recruiting
Led By John B. Williamson, PhD
Research Sponsored by VA Office of Research and Development
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Condition: Hx VA/DOD criteria PTSD w or w/o mTBI and current sig symptoms of PTSD
Be between 18 and 65 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up one night comparison
Awards & highlights

NINS Trial Summary

This trial is testing whether two different types of brain stimulation can help people with sleep difficulties.

Who is the study for?
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.Check my eligibility
What is being tested?
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.See study design
What are the potential side effects?
While specific side effects aren't listed here, non-invasive nerve stimulation may cause discomfort at the site of application or a tingling sensation. More serious side effects could include changes in mood or skin irritation but generally it's considered low risk.

NINS Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
I have PTSD with or without a mild brain injury, and I'm currently experiencing significant symptoms.

NINS Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~one night comparison
This trial's timeline: 3 weeks for screening, Varies for treatment, and one night comparison for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Polysomnography

NINS Trial Design

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.

Find a Location

Who is running the clinical trial?

VA Office of Research and DevelopmentLead Sponsor
1,611 Previous Clinical Trials
3,305,180 Total Patients Enrolled
John B. Williamson, PhDPrincipal InvestigatorNorth Florida/South Georgia Veterans Health System, Gainesville, FL

Media Library

non-invasive nerve stimulation (Behavioural Intervention) Clinical Trial Eligibility Overview. Trial Name: NCT04021537 — Phase 2 & 3
Post-Traumatic Stress Disorder Research Study Groups: non-invasive nerve stimulation a, non-invasive nerve stimulation b
Post-Traumatic Stress Disorder Clinical Trial 2023: non-invasive nerve stimulation Highlights & Side Effects. Trial Name: NCT04021537 — Phase 2 & 3
non-invasive nerve stimulation (Behavioural Intervention) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04021537 — Phase 2 & 3
Post-Traumatic Stress Disorder Patient Testimony for trial: Trial Name: NCT04021537 — Phase 2 & 3

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What are the requirements to join this clinical trial?

"The main inclusion criteria for this study is that patients must have a PTSD diagnosis and be between 18-55 years old. They are aiming to enroll around 104 individuals in the trial."

Answered by AI

Are investigators still enrolling new subjects for this research study?

"From what is available on clinicaltrials.gov, it seems that this trial is still looking for participants. The listing was first put up on 1/30/2020, with the latest update being from 1/7/2022."

Answered by AI

Does this experiment only allow volunteers who are under the age of eighty?

"To be eligible for this specific clinical trial, patients must between 18-55 years old. There are other trials available for both those under 18 years old (36 in total) and people over 65 (251 in total)."

Answered by AI

How many people are currently taking part in this research project?

"That is correct, the online information does show that this study is open for recruitment. The posting date was 1/30/2020 and there have been edits as recent as 1/7/2022. They are looking for a total of 104 individuals from 1 site."

Answered by AI

Who else is applying?

What state do they live in?
Indiana
New York
Other
Florida
How old are they?
18 - 65
What site did they apply to?
North Florida/South Georgia Veterans Health System, Gainesville, FL
What portion of applicants met pre-screening criteria?
Did not meet criteria
Met criteria
How many prior treatments have patients received?
1

Why did patients apply to this trial?

I’m very interested.
PatientReceived no prior treatments

How responsive is this trial?

Typically responds via
Email
Recent research and studies
clinicaltrials.govStudy
Non-invasive Nerve Stimulation and Sleep
2020. "Non-invasive Nerve Stimulation and Sleep". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04021537.
All > Ptsd
~11 spots leftby Oct 2024
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