Non-invasive Nerve Stimulation and Sleep (NINS)

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.

Study Overview

• Status: Active, not recruiting
• Conditions: PTSD
• Intervention / Treatment: Device: non-invasive nerve stimulation

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 Type: Interventional
• Enrollment (Actual): 87
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Florida
    • Gainesville, Florida, United States, 32608-1135
      • North Florida/South Georgia Veterans Health System, Gainesville, FL

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 55 years (Adult)
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

• Condition: Hx VA/DOD criteria PTSD w or w/o mTBI and current sig symptoms of PTSD
• English fluency

Exclusion Criteria:

• 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

• 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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: non-invasive nerve stimulation a; Electrical stimulation will be delivered to a location at the ear.	Device: non-invasive nerve stimulation; Electrical stimulation will be provided via a TENS unit.
Sham Comparator: non-invasive nerve stimulation b; Electrical stimulation will be delivered to a location at the ear for two minutes and rolled off to zero slowly.	Device: non-invasive nerve stimulation; Electrical stimulation will be provided via a TENS unit.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Polysomnography	Polysomnography measures. Slow wave sleep time. Rem sleep time.	One night comparison

Collaborators and Investigators

• Sponsor: VA Office of Research and Development
• Investigators: Principal Investigator: John B. Williamson, PhD, North Florida/South Georgia Veterans Health System, Gainesville, FL

Publications and helpful links

General 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.

Study record dates

Study Major Dates

• Study Start (Actual): January 30, 2020
• Primary Completion (Actual): October 1, 2025
• Study Completion (Estimated): October 1, 2026

Study Registration Dates

• First Submitted: June 25, 2019
• First Submitted That Met QC Criteria: July 12, 2019
• First Posted (Actual): July 16, 2019

Study Record Updates

• Last Update Posted (Actual): March 2, 2026
• Last Update Submitted That Met QC Criteria: February 26, 2026
• Last Verified: February 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Trauma and Stressor Related Disorders; Mental Disorders; Stress Disorders, Traumatic; Stress Disorders, Post-Traumatic
• Other Study ID Numbers: N3140-R; 1RX003140A (Other Grant/Funding Number: Dept of Veterans Affairs)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: No