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: 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.

• Study Type: Interventional
• Enrollment (Estimated): 104
• Phase: Phase 2; Phase 3

Contacts and Locations

• Study Contact: Name: John B Williamson, PhD; Phone Number: (352) 376-1611; Email: john.williamson2@va.gov
• Study Contact Backup: Name: Richard B Berry, MD; Phone Number: 106241 (352) 376-1611; Email: richard.berry@va.gov

Study Locations

• United States
  • Florida
    • Gainesville, Florida, United States, 32608-1135
      • Recruiting
      • North Florida/South Georgia Veterans Health System, Gainesville, FL
      • Contact: Stephen E Nadeau, MD BS BS; Phone Number: 352-548-6551; Email: Stephen.Nadeau@va.gov
      • Contact: Russell M Bauer, PhD; Email: rbauer@phhp.ufl.edu
      • Principal Investigator: John B. Williamson, PhD

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.
Active Comparator: non-invasive nerve stimulation b; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Polysomnography	Polysomnography measures sleep architecture.	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

Study record dates

Study Major Dates

• Study Start (Actual): January 30, 2020
• Primary Completion (Estimated): October 31, 2024
• Study Completion (Estimated): October 31, 2024

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 (Estimated): January 26, 2024
• Last Update Submitted That Met QC Criteria: January 24, 2024
• Last Verified: January 1, 2024

More Information

Terms related to this study

• 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