Clinical trial NCT04021537: Non-invasive Nerve Stimulation and Sleep
Official title: Transcutaneous Vagal Nerve Stimulation Improvement of Sleep Quality in Veterans With PTSD With or Without History of Mild TBI
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: PTSD
Lead sponsor: VA Office of Research and Development
Sponsor class: FED
First posted: 2019-07-16
Enrollment: 104
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Intervention model description: The study is a cross-over design comparing two stimulation types. The order of stimulation is randomly assigned.
Primary purpose: TREATMENT

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.

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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Polysomnography
timeFrame: One night comparison
Secondary outcomes:
Other outcomes:
Locations:
city: Gainesville
country: United States
facility: North Florida/South Georgia Veterans Health System, Gainesville, FL
state: Florida
Study officials:
affiliation: North Florida/South Georgia Veterans Health System, Gainesville, FL
name: John B. Williamson, PhD
role: PRINCIPAL_INVESTIGATOR
References: