Traumatic Brain Injury Clinical Trial
Official title:
Non-invasive Vagal Nerve Stimulation and Sleep
In this study, our objective is to determine the effect of two different nerve stimulation types in changing sleep architecture.
| Status | Recruiting |
| Enrollment | 221 |
| Est. completion date | November 30, 2024 |
| Est. primary completion date | October 30, 2024 |
| Accepts healthy volunteers | Accepts Healthy Volunteers |
| Gender | All |
| Age group | 18 Years to 55 Years |
| Eligibility | Inclusion Criteria: - veterans with history of PTSD with and without history of mild TBI Exclusion Criteria with: - history of severe psychiatric illness unrelated to PTSD or TBI - other medical conditions of severity that may impair cognition - current illicit or prescription drug abuse - breathing disorder requiring constant use of oxygen |
| Country | Name | City | State |
|---|---|---|---|
| United States | North Florida/South Georgia Veterans Health System | Gainesville | Florida |
| United States | University of Florida | Gainesville | Florida |
| Lead Sponsor | Collaborator |
|---|---|
| University of Florida | North Florida/South Georgia Veterans Health System, US Department of Veterans Affairs |
United States,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Physiological sleep architectural quality | Polysomnography | up to 8 hours |
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