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The BEST Study: The Efficacy of Brain Entrainment Sleep Technology in Military Healthcare Beneficiaries

NCT03169309 · Status: TERMINATED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 7

Last updated 2017-11-29

No results posted yet for this study

Summary

Brain Entrainment Technology (BET), also known as Binaural Beat Technology (BBT); is an auditory-neurophysiologic technique which uses auditory tones (often embedded in music, nature sounds or white noise) dichotically via stereo headphones to manipulate brainwave activity in turn affecting the listener's mental, physical and/or emotional state. Although this technology is widely marketed to the general public and can be found free in on the internet, only a hand full of scientific studies have shown its efficacy. This study is a follow-on study to the "Sound Mind Warrior (SMW) Study" (ClinicalTrials.gov \[NCT02328690\]) conducted 2012-2015 which assessed the efficacy of the technology (in the "theta" brainwave frequency) on the cardiovascular stress response in a group of service members with complaint of chronic stress. This study will now assess BET (in the "delta" brainwave frequency) on sleep quality in a population of military healthcare beneficiaries with complaint of poor sleep quality.

Conditions

  • Sleep
  • Sleep Disorders
  • Sleep Deprivation
  • Sleep Disturbance
  • Sleep Disorders, Intrinsic
  • Sleep Disorders, Circadian Rhythm

Interventions

DEVICE

Brain Entrainment Technology

Brain Entrainment Technology (BET), also known as Binaural Beat Technology (BBT), is a sound technology where two slightly different tones are present to each ear and the brain produces a third tone. This third tone impacts the reticular activating system which alters the action potentials of the thalamus and cerebral cortex in turn changing the brain wave frequency to alter the state of consciousness of the listener.

Sponsors & Collaborators

  • Landstuhl Regional Medical Center

    lead FED

Principal Investigators

  • MeLisa Gantt, PhD · Gantt Clinical Institute LLC

Study Design

Allocation
NA
Purpose
SUPPORTIVE_CARE
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2017-01-31
Primary Completion
2017-09-30
Completion
2017-09-30

Countries

  • Germany

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 NCT03169309 on ClinicalTrials.gov