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OpenTrials
Active, Not Recruiting

NCT Number: NCT04021537

Non-invasive Nerve Stimulation and Sleep

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.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

Key information

Age range

18 year–55 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

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

Gainesville, Florida, 32608-1135, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

non-invasive nerve stimulation

Device

Electrical stimulation will be provided via a TENS unit.

Primary outcomes

  1. Polysomnography

    Time frame: One night comparison

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

Sponsors and collaborators

Lead sponsor

VA Office of Research and Development

Fed

Registry information

Official study title

Transcutaneous Vagal Nerve Stimulation Improvement of Sleep Quality in Veterans With PTSD With or Without History of Mild TBI

Acronym: NINS

Important dates

Study start
2020
Primary completion
2025
Study completion
2026
First posted
Jul 16, 2019
Registry last updated
Mar 2, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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