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

NCT03169309 | Terminated

• 1 other identifier: M-10544
• Study Type: interventional
• Target: 7
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

complementary and alternative medicine; military; binaural beat technology; brain entrainment technology; sleep

Outcome Measures

Primary Outcomes (1)

• "Quantitative" Sleep Quality (via Sleep Actigraphy Watch)

  Sleep actigraphy monitor will measure wake/sleep. Using special software, that information is then articulated into graphical and tabulated report that shows the movement that occurred throughout the wake and sleep cycles as well as light exposure that may have affected sleep. The report gives the a) time the participants went to bed, b) time they woke up, c) number of hours they were in the bed, d) total number of hours asleep, e) number of minutes it took to fall asleep, f) percent efficiency of their sleep, g) number of minutes awaken after sleep onset, and h) total number of times they woke up after falling asleep.

  Daily over the course of 4 weeks

Secondary Outcomes (6)

• Insomnia Severity Level (via Insomnia Severity Index Questionnaire)

  Baseline

• "Qualitative" Sleep Quality (via Sleep Foundation Sleep Diary Questionnaire)

  Daily over the course of 4 weeks

• Overall Impression of Sleep Quality (via Pittsburgh Sleep Quality Index Questionnaire)

  Baseline and Week 4 (after using intervention)

• Inflammatory Biomarker (via C-Reactive Protein Lab)

  Baseline and Week 4 (after using intervention)

• Extenuating Factor Affecting C-Reactive Protein Level (via C-Reactive Protein Questionnaire)

  Baseline and Week 4 (after using intervention)

Study Arms (1)

Pre and Post Intervention

EXPERIMENTAL

One Study Arm - Quantitative and qualitative sleep quality measure will be captured at baseline (Phase I/Week 1-2), while using Brain Entrainment Technology (Phase II/Week3-4), and after using the technology.

Device: Brain Entrainment Technology

Interventions

Brain Entrainment Technology DEVICE

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.

Also known as: Binaural Beat Technology

Pre and Post Intervention

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Score greater than or equal to 15 on the Insomnia Severity Index (ISI)
• Affiliated with at least one of the 13 installations within the Kaiserslautern Military Community (KMC) area
• Eligible to receive healthcare at Landstuhl Regional Medical Center (LRMC)
• Are 18 years or older
• Can read and speak English
• Are able to commit to a 4 week study

You may not qualify if:

• Are taking any type of medication that causes drowsiness
• Have been diagnosed with moderate to severe traumatic brain injury (TBI)
• Have a history of epilepsy
• Are taking any medication in the anti-seizure category
• Have been diagnosed with, taking medication for, or are currently being evaluated for a psychological health issue as defined by the Diagnostic and Statistical Manual of Mental Disorders, 5th Edition (DSM-5) that will prohibit them from using intervention as perscribed.
• Have ear trauma, difficulty hearing or wear a hearing aide
• Have a chronic inflammatory health issue
• Are pregnant or are trying to become pregnant in the next 4 weeks
• \*Women of child bearing age will be asked to provide a urine sample for a pregnancy test
• Are currently using BET

Sponsors & Collaborators

• Landstuhl Regional Medical Center: lead

Study Sites (1)

Landstuhl Regional Medical Center

Landstuhl, Germany

Location

MeSH Terms

Conditions

Sleep Wake Disorders; Sleep Deprivation; Parasomnias; Sleep Disorders, Intrinsic; Sleep Disorders, Circadian Rhythm

Condition Hierarchy (Ancestors)

Nervous System Diseases; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Mental Disorders; Dyssomnias; Chronobiology Disorders; Occupational Diseases

Study Officials

• MeLisa Gantt, PhD

  Gantt Clinical Institute LLC

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: SINGLE GROUP
• Sponsor Type: FED
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: (former) Chief, CNSCI

Model Details: Pre- and post- intervention trial

Study Record Dates

• First Submitted: March 7, 2017
• First Posted: May 30, 2017
• Study Start: January 1, 2017
• Primary Completion: September 1, 2017
• Study Completion: September 1, 2017
• Last Updated: November 29, 2017

Record last verified: 2017-11

Data Sharing

• IPD Sharing: Will not share

Locations

DE (1)