PTSDNINSNCT04021537
Non-invasive Nerve Stimulation and Sleep
A study testing non-invasive nerve stimulation in people with PTSD, run by VA Office of Research and Development at 1 site in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- PTSD
- What is being tested?
- non-invasive nerve stimulation
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 87 participants
- Where
- 1 siteUnited States
- Study dates
- 30 Jan 2020to 1 Oct 2026
- 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
- Condition: Hx VA/DOD criteria PTSD w or w/o mTBI and current sig symptoms of PTSD
- English fluency
Who cannot join
- Neurological injuries or conditions aside from mTBI that may affect outcome variables and/or other variables in the study
- Psychiatric issues that are unlikely to be related to trauma that may affect outcomes and/or other variables in the
- e.g., schizophrenia
- Untreated sleep apnea
- CPAP controlled sleep apnea is okay
- Major uncorrected sensory deficit
Show all 10Show fewer
- Current drug or alcohol abuse
- Drug abuse within the last two months will result in exclusion or delay
- Marijuana use or alcohol intoxication within 2 weeks of study will be acceptable
- No pregnancy
Trial locations and contacts
1 site in 1 country.
United States1 site
North Florida/South Georgia Veterans Health System, Gainesville, FL
Gainesville, Florida, 32608-1135
About this study
Official title: Transcutaneous Vagal Nerve Stimulation Improvement of Sleep Quality in Veterans With PTSD With or Without History of Mild TBI
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.
Read the detailed description
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.
Prior to the cross-over study described here, a dosing study will be completed. Twenty Veterans with PTSD with or without history of mTBI, assessed for inclusion and exclusion per protocol, will be evaluated over three polysomnography nights with at least a one week washout period. Pseudo-randomly distributed across the three nights, each participant will be tested on three of the 10 parameters, creating a total of 60 testing sessions (6 for each parameter setting with each represented twice in each night slot). primary sleep architecture variables (slow wave sleep time, REM sleep time) and autonomic responses will be used as outcomes. The optimal dose will be selected and the study will proceed to the cross-over design phase.
- Conditions
- PTSD
- Being tested
- non-invasive nerve stimulation
- Medical subject headings
- Stress Disorders, Post-Traumatic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
non-invasive nerve stimulationDevice
Electrical stimulation will be provided via a TENS unit.
| Study group | Role | What they receive |
|---|---|---|
| non-invasive nerve stimulation a | Experimental | Electrical stimulation will be delivered to a location at the ear. Receives: Device: non-invasive nerve stimulation |
| non-invasive nerve stimulation b | Sham comparator | Electrical stimulation will be delivered to a location at the ear for two minutes and rolled off to zero slowly. Receives: Device: non-invasive nerve stimulation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Polysomnography
Polysomnography measures. Slow wave sleep time. Rem sleep time.
Measured: One night comparison
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Jul 2019
- Study start30 Jan 2020
- Primary completion1 Oct 2025
- Study completion1 Oct 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for PTSDStudies of the same condition, open and under way.
- More trials run by VA Office of Research and DevelopmentThe 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- The study is a cross-over design comparing two stimulation types. The order of stimulation is randomly assigned. Note, there is also a dosing study. Enrollment includes the dosing study (21 participants, 3 nights each). crossover enrollment = 66
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 87 participants (actual)
Sponsor and investigators
- Lead sponsor
- VA Office of Research and Development
- Sponsor type
- US federal agency
- Responsible party
- Sponsor
- Investigators
- John B. Williamson, PhD, Principal investigator, North Florida/South Georgia Veterans Health System, Gainesville, FL
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04021537
- Sponsor's protocol ID
- N3140-R
- Other IDs
- 1RX003140A
- Acronym
- NINS
- Status last verified
- Feb 2026
- First submitted
- 25 Jun 2019
- Last updated
- 2 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Publications
Bottari SA, Trifilio ER, Rohl B, Wu SS, Miller-Sellers D, Waldorff I, Hadigal S, Jaffee MS, Ferri R, Lamb DG, Porges EC, Williamson JB. Optimizing transcutaneous vagus nerve stimulation parameters for sleep and autonomic function in veterans with posttraumatic stress disorder with or without mild traumatic brain injury. Sleep. 2025 Aug 14;48(8):zsaf152. doi: 10.1093/sleep/zsaf152.
PubMed 40489292
Study at a glance
From the registry record, last updated by the sponsor on 2 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Transcutaneous Vagal Nerve Stimulation Improvement of Sleep Quality in Veterans With PTSD With or Without History of Mild TBI
- ClinicalTrials.gov ID
- NCT04021537
- Acronym / sponsor ID
- NINS / N3140-R
- Conditions
- PTSD
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 87 participants (actual)
- Lead sponsor
- VA Office of Research and DevelopmentUS federal agency
- Study start
- 30 Jan 2020 (actual)
- Primary completion
- 1 Oct 2025 (actual)
- Study completion
- 1 Oct 2026 (estimated)
- First posted
- 16 Jul 2019 (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.
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.
Detailed description
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.
Prior to the cross-over study described here, a dosing study will be completed. Twenty Veterans with PTSD with or without history of mTBI, assessed for inclusion and exclusion per protocol, will be evaluated over three polysomnography nights with at least a one week washout period. Pseudo-randomly distributed across the three nights, each participant will be tested on three of the 10 parameters, creating a total of 60 testing sessions (6 for each parameter setting with each represented twice in each night slot). primary sleep architecture variables (slow wave sleep time, REM sleep time) and autonomic responses will be used as outcomes. The optimal dose will be selected and the study will proceed to the cross-over design phase.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
- Model description
- The study is a cross-over design comparing two stimulation types. The order of stimulation is randomly assigned. Note, there is also a dosing study. Enrollment includes the dosing study (21 participants, 3 nights each). crossover enrollment = 66
| Arm | Type | Receives |
|---|---|---|
| non-invasive nerve stimulation a | Experimental | Device: non-invasive nerve stimulationElectrical stimulation will be delivered to a location at the ear. |
| non-invasive nerve stimulation b | Sham comparator | Device: non-invasive nerve stimulationElectrical stimulation will be delivered to a location at the ear for two minutes and rolled off to zero slowly. |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- Condition: Hx VA/DOD criteria PTSD w or w/o mTBI and current sig symptoms of PTSD
- English fluency
Key exclusion criteria (10 listed)
- Neurological injuries or conditions aside from mTBI that may affect outcome variables and/or other variables in the study
- Psychiatric issues that are unlikely to be related to trauma that may affect outcomes and/or other variables in the
- Untreated sleep apnea
- Major uncorrected sensory deficit
- Current drug or alcohol abuse
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 |
|---|---|---|
| non-invasive nerve stimulationElectrical stimulation will be provided via a TENS unit. | Device | non-invasive nerve stimulation a, non-invasive nerve stimulation b |
Primary outcome
Polysomnography
Time frame: One night comparison
Polysomnography measures. Slow wave sleep time. Rem sleep time.
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 2 Mar 2026.
- Derived from this study: PubMed 40489292Bottari SA, Trifilio ER, Rohl B, Wu SS, Miller-Sellers D, Waldorff I, Hadigal S, Jaffee MS, Ferri R, Lamb DG, Porges EC, Williamson JB. Optimizing transcutaneous vagus nerve stimulation parameters for sleep and autonomic function in veterans with posttraumatic stress disorder with or without mild traumatic brain injury. Sleep. 2025 Aug 14;48(8):zsaf152. doi: 10.1093/sleep/zsaf152.
- 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. This study is not recruiting at the moment.
John B. Williamson, PhD principal investigator
North Florida/South Georgia Veterans Health System, Gainesville, FL
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing non-invasive nerve stimulation in people with PTSD, run by VA Office of Research and Development at 1 site 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 2 inclusion and 10 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: under way, not looking for participants, as of the sponsor's last update on 2 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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. Some participants in this study may receive a placebo. 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?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Polysomnography (time frame: One night comparison). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04021537, which also lists 1 linked publication.
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 2 Mar 2026.