Post Traumatic Stress DisorderNCT03170440
Non-invasive Nerve Stimulation for PTSD and Sleep
A study testing Transcutaneous nerve stimulation location 1 in people with Post Traumatic Stress Disorder and Traumatic Brain Injury, run by University of Florida at 3 sites in United States.
Trial summary
In this study, our objective is to determine the effect of two different nerve stimulation types in changing sleep architecture. Read more about this study
- Who is it for?
- Ages 18 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Post Traumatic Stress Disorder, Traumatic Brain Injury
- What is being tested?
- Transcutaneous nerve stimulation location 1
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 221 participants
- Where
- 3 sitesUnited States
- Study dates
- 1 Nov 2017to 30 Oct 2025
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 55 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- veterans with history of PTSD with and without history of mild TBI
Who cannot join
- history of severe psychiatric illness unrelated to PTSD or TBI
- other medical conditions of severity that may impair cognition
- current illicit or prescription drug abuse
- breathing disorder requiring constant use of oxygen
Trial locations and contacts
3 sites in 1 country. Contact the study team or a site near you to ask about taking part.
United States3 sites, 3 recruiting
- Recruiting
UF Health Jacksonville
Gainesville, Florida, 32608
Meghan Marotz, MS, 904-244-9620, meghan.marotz@jax.ufl.edu
John Williamson, PhD, 3523761611 ext. 106920, john.williamson@ufl.edu
- Recruiting
University of Florida
Gainesville, Florida, 32610
John Williamson, PhD, 352-294-4903, john.williamson@ufl.edu
John Williamson, Ph.D.
- Recruiting
UF Health Jacksonville
Jacksonville, Florida, 32209
Meghan Marotz, MS, 904-244-9620, meghan.marotz@jax.ufl.edu
About this study
Official title: Non-invasive Vagal Nerve Stimulation and Sleep
In this study, our objective is to determine the effect of two different nerve stimulation types in changing sleep architecture.
Read the detailed description
Persons suffering from PTSD or mild TBI may suffer from sleep deprivation. The purpose of this study is to explore options to improve sleep quality.
- Being tested
- Transcutaneous nerve stimulation location 1
- Keywords
- Nerve stimulation, sleep deprivation
- Medical subject headings
- Stress Disorders, Post-Traumatic, Brain Injuries, Traumatic, Sleep Deprivation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Transcutaneous nerve stimulation location 1Device
Non-invasive stimulation by transcutaneous electrical nerve stimulation device in test location
| Study group | Role | What they receive |
|---|---|---|
| Noninvasive nerve stimulation type I | Experimental | This group will receive one type of nerve stimulation Receives: Device: Transcutaneous nerve stimulation location 1 |
| Noninvasive nerve stimulation type II | Active comparator | This group will receive second type of nerve stimulation Receives: Device: Transcutaneous nerve stimulation location 1 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Physiological sleep architectural quality
Polysomnography
Measured: up to 8 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 May 2017
- Study start1 Nov 2017
- Primary completion30 Oct 2025 (estimated)
- Study completion30 Oct 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Post Traumatic Stress DisorderStudies of the same condition, open and under way.
- More trials run by University of FloridaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 221 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Florida
- Sponsor type
- University, hospital or other
- Collaborators
- US Department of Veterans Affairs, North Florida/South Georgia Veterans Health System
- Responsible party
- Sponsor
- Investigators
- John Williamson, Ph.D., Principal investigator, University of Florida
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03170440
- Sponsor's protocol ID
- IRB201700541
- Other IDs
- i01 rx003140-01a, I01RX003140-01
- Status last verified
- Jun 2025
- First submitted
- 23 May 2017
- Last updated
- 1 Jul 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Non-invasive Vagal Nerve Stimulation and Sleep
- ClinicalTrials.gov ID
- NCT03170440
- Acronym / sponsor ID
- IRB201700541
- Keywords
- Nerve stimulation, sleep deprivation
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 221 participants (estimated)
- Lead sponsor
- University of FloridaUniversity, hospital or other
- Collaborators
- US Department of Veterans Affairs, North Florida/South Georgia Veterans Health System
- Study start
- 1 Nov 2017 (actual)
- Primary completion
- 30 Oct 2025 (estimated)
- Study completion
- 30 Oct 2025 (estimated)
- First posted
- 31 May 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
In this study, our objective is to determine the effect of two different nerve stimulation types in changing sleep architecture.
Detailed description
Persons suffering from PTSD or mild TBI may suffer from sleep deprivation. The purpose of this study is to explore options to improve sleep quality.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Noninvasive nerve stimulation type I | Experimental | Device: Transcutaneous nerve stimulation location 1This group will receive one type of nerve stimulation |
| Noninvasive nerve stimulation type II | Active comparator | Device: Transcutaneous nerve stimulation location 1This group will receive second type of nerve stimulation |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- veterans with history of PTSD with and without history of mild TBI
Key exclusion criteria (4 listed)
- history of severe psychiatric illness unrelated to PTSD or TBI
- other medical conditions of severity that may impair cognition
- current illicit or prescription drug abuse
- breathing disorder requiring constant use of oxygen
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Transcutaneous nerve stimulation location 1Non-invasive stimulation by transcutaneous electrical nerve stimulation device in test location | Device | Noninvasive nerve stimulation type I, Noninvasive nerve stimulation type II |
Primary outcome
Physiological sleep architectural quality
Time frame: up to 8 hours
Polysomnography
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Jul 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
John Williamson, Ph.D. principal investigator
University of Florida
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Transcutaneous nerve stimulation location 1 in people with Post Traumatic Stress Disorder and Traumatic Brain Injury, run by University of Florida at 3 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 1 Jul 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact John Williamson, PhD (35523761611 ext. 106920, john.williamson2@va.gov), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Physiological sleep architectural quality (time frame: up to 8 hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Jul 2025.