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| ID | Type | Description | Link |
|---|---|---|---|
| 1RX003140A | Other Grant/Funding Number | Dept of Veterans Affairs |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| non-invasive nerve stimulation a | Experimental | Electrical stimulation will be delivered to a location at the ear. |
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| non-invasive nerve stimulation b | Sham Comparator | Electrical stimulation will be delivered to a location at the ear for two minutes and rolled off to zero slowly. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| non-invasive nerve stimulation | Device | Electrical stimulation will be provided via a TENS unit. |
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| Measure | Description | Time Frame |
|---|---|---|
| Polysomnography | Polysomnography measures. Slow wave sleep time. Rem sleep time. | One night comparison |
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Inclusion Criteria:
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
Untreated sleep apnea
Major uncorrected sensory deficit
Current drug or alcohol abuse
No pregnancy
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| Name | Affiliation | Role |
|---|---|---|
| John B. Williamson, PhD | North Florida/South Georgia Veterans Health System, Gainesville, FL | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| North Florida/South Georgia Veterans Health System, Gainesville, FL | Gainesville | Florida | 32608-1135 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 40489292 | Derived | Bottari SA, Trifilio ER, Rohl B, Wu SS, Miller-Sellers D, Waldorff I, Hadigal S, Jaffee MS, Ferri R, Lamb DG, Porges EC, Williamson JB. Optimizing transcutaneous vagus nerve stimulation parameters for sleep and autonomic function in veterans with posttraumatic stress disorder with or without mild traumatic brain injury. Sleep. 2025 Aug 14;48(8):zsaf152. doi: 10.1093/sleep/zsaf152. |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| ICF | No | No | Yes | Informed Consent Form | May 30, 2025 | Feb 26, 2026 | ICF_000.pdf |
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| ID | Term |
|---|---|
| D013313 | Stress Disorders, Post-Traumatic |
| ID | Term |
|---|---|
| D040921 | Stress Disorders, Traumatic |
| D000068099 | Trauma and Stressor Related Disorders |
| D001523 | Mental Disorders |
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The study is a cross-over design comparing two stimulation types. The order of stimulation is randomly assigned. Note, there is also a dosing study. Enrollment includes the dosing study (21 participants, 3 nights each). crossover enrollment = 66
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