Non-invasive Nerve Stimulation and Sleep

PTSD Clinical Trial

— NINS  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04021537
• Other study ID #: N3140-R
• Secondary ID: 1RX003140A
• Status: Recruiting
• Phase: Phase 2/Phase 3
• Start date: January 30, 2020
• Est. completion date: October 31, 2024

Study information

• Verified date: January 2024
• Source: VA Office of Research and Development
• Contact: John B Williamson, PhD
• Phone: (352) 376-1611
• Email: john.williamson2[@]va.gov
• Is FDA regulated: No
• Study type: Interventional

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

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 104
• Est. completion date: October 31, 2024
• Est. primary completion date: October 31, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 55 Years

Eligibility

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

Related Conditions & MeSH terms

• PTSD

Intervention

Device:
• non-invasive nerve stimulation
Electrical stimulation will be provided via a TENS unit.

Locations

Country	Name	City	State
United States	North Florida/South Georgia Veterans Health System, Gainesville, FL	Gainesville	Florida

Sponsors (1)

Lead Sponsor	Collaborator
VA Office of Research and Development

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Polysomnography	Polysomnography measures sleep architecture.	One night comparison