Non-invasive Nerve Stimulation and Sleep

NCT04021537 | Active Not Recruiting FDA Device

• 2 other identifiers: N3140-R1RX003140A
• Study Type: interventional
• Target: 87
• Locations: 1 country
• Sites: 1

Brief 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. In this study, the investigators are testing two nerve stimulation locations that may impact brain function in such a way that sleep is improved.

Conditions

PTSD

Outcome Measures

Primary Outcomes (1)

• Polysomnography

  Polysomnography measures. Slow wave sleep time. Rem sleep time.

  One night comparison

Study Arms (2)

non-invasive nerve stimulation a

EXPERIMENTAL

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

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.

Device: non-invasive nerve stimulation

Interventions

non-invasive nerve stimulation DEVICE

Electrical stimulation will be provided via a TENS unit.

non-invasive nerve stimulation a; non-invasive nerve stimulation b

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

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

You may not qualify if:

• 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
• Marijuana use or alcohol intoxication within 2 weeks of study will be acceptable
• No pregnancy

Sponsors & Collaborators

• VA Office of Research and Development: lead

Study Sites (1)

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

Gainesville, Florida, 32608-1135, United States

Location

Related Publications (1)

• 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.

  PMID: 40489292 DERIVED

MeSH Terms

Conditions

Stress Disorders, Post-Traumatic

Condition Hierarchy (Ancestors)

Stress Disorders, Traumatic; Trauma and Stressor Related Disorders; Mental Disorders

Study Officials

• John B. Williamson, PhD

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

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: FED
• Responsible Party: SPONSOR

Model Details: 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

Study Record Dates

• First Submitted: June 25, 2019
• First Posted: July 16, 2019
• Study Start: January 30, 2020
• Primary Completion: October 1, 2025
• Study Completion (Estimated): October 1, 2026
• Last Updated: March 2, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)