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Study of Low Field Magnetic Stimulation (LFMS) on Measures of Sleep

NCT03050372 · Status: TERMINATED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 12

Last updated 2020-02-13

Study results available
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Summary

Participants will be recruited and screened through ongoing studies in the sleep and anxiety disorders clinic. Participants with insomnia will be consented to complete several questionnaires, undergo a brief physical exam, provide a urinalysis, and undergo 5 nights of active or sham Low Field Magnetic Stimulation (LFMS) followed by an overnight sleep study. Each of the two treatment conditions (active versus sham) will be conducted on two consecutive nights. There will be no more than 7 days between the adaptation night and the first treatment condition and no more than 7 nights between each of the two-night treatment conditions . Thus, each participant who completes the full study will spend a total of 5 nights in the sleep laboratory and the time interval from the first adaptation night to completion of the study may range from 5-19 days for any particular individual.

Conditions

  • Insomnia, Primary

Interventions

DEVICE

LFMS - Active

A non-invasive form of brain stimulation administered from a device resembling a bird cage. The device covers the top part of the head for the duration of stimulation (in the current study, 20 minutes)

DEVICE

LFMS - Sham

A simulation of the LFMS-Active intervention, using the same device that produces a sound similar to the sound made by the device during the active treatment, for a similar duration (in the current study, 20 minutes)

Sponsors & Collaborators

  • Tal Medical, Inc.

    collaborator INDUSTRY

  • Medical University of South Carolina

    lead OTHER

Principal Investigators

  • Thomas Uhde, MD · Medical University of South Carolina

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
CROSSOVER

Eligibility

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

Timeline & Regulatory

Start
2016-11-30
Primary Completion
2018-12-31
Completion
2018-12-31

Countries

  • United States

Study Locations

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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 NCT03050372 on ClinicalTrials.gov