Non-invasive Nerve Stimulation and Sleep

NCT ID: NCT04021537

Last Updated: 2025-05-13

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 104 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-01-30
• Study Completion Date: 2025-11-29

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.

Conditions

PTSD

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: TREATMENT
• Blinding Strategy: TRIPLE

Study Groups

non-invasive nerve stimulation a

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

Group Type: EXPERIMENTAL

non-invasive nerve stimulation

Intervention Type: DEVICE

Electrical stimulation will be provided via a TENS unit.

non-invasive nerve stimulation b

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

Group Type: SHAM_COMPARATOR

non-invasive nerve stimulation

Intervention Type: DEVICE

Electrical stimulation will be provided via a TENS unit.

Interventions

non-invasive nerve stimulation

Electrical stimulation will be provided via a TENS unit.

Intervention Type: DEVICE

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 55 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

VA Office of Research and Development

FED

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

John B. Williamson, PhD

Role: PRINCIPAL_INVESTIGATOR

North Florida/South Georgia Veterans Health System, Gainesville, FL

Locations

North Florida/South Georgia Veterans Health System, Gainesville, FL

Gainesville, Florida, United States

Site Status: RECRUITING

Countries

United States

Central Contacts

John B Williamson, PhD

Role: CONTACT

john.williamson2@va.gov

(352) 376-1611

Richard B Berry, MD

Role: CONTACT

richard.berry@va.gov

(352) 376-1611 ext. 106241

Facility Contacts

Stephen E Nadeau, MD BS BS

Role: primary

Stephen.Nadeau@va.gov

352-548-6551

Russell M Bauer, PhD

Role: backup

rbauer@phhp.ufl.edu

References

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.

Reference Type: DERIVED

PMID: 40489292 (View on PubMed)

Other Identifiers

1RX003140A

Identifier Type: OTHER_GRANT

Identifier Source: secondary_id

N3140-R

Identifier Type: -

Identifier Source: org_study_id