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Non-invasive Nerve Stimulation and Sleep

NCT04021537 · Status: ACTIVE_NOT_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 87

Last updated 2026-03-02

No results posted yet for this study

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.

Conditions

Interventions

DEVICE

non-invasive nerve stimulation

Electrical stimulation will be provided via a TENS unit.

Sponsors & Collaborators

  • VA Office of Research and Development

    lead FED

Principal Investigators

  • John B. Williamson, PhD · North Florida/South Georgia Veterans Health System, Gainesville, FL

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Max Age
55 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2020-01-30
Primary Completion
2025-10-01
Completion
2026-10-01
FDA Device
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04021537 on ClinicalTrials.gov