Non-invasive Nerve Stimulation and Sleep (NINS)

VA Office of Research and Development

Status: Enrolling

Conditions: PTSD

Treatments: Device: non-invasive nerve stimulation

Study type: Interventional

Funder types: Other U.S. Federal agency

Identifiers

NCT04021537

N3140-R

1RX003140A (Other Grant/Funding Number)

Details and patient eligibility

About

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.

Full 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.

Enrollment: 104 estimated patients

Sex: All

Ages: 18 to 55 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Triple Blind

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104 participants in 2 patient groups

non-invasive nerve stimulation a

Experimental group

Description:

Electrical stimulation will be delivered to a location at the ear.

Treatment:

Device: non-invasive nerve stimulation

non-invasive nerve stimulation b

Sham Comparator group

Description:

Electrical stimulation will be delivered to a location at the ear for two minutes and rolled off to zero slowly.

Treatment:

Device: non-invasive nerve stimulation