The BEST Study: The Efficacy of Brain Entrainment Sleep Technology in Military Healthcare Beneficiaries
NCT ID: NCT03169309
Last Updated: 2017-11-29
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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TERMINATED
NA
7 participants
INTERVENTIONAL
2017-01-31
2017-09-30
Brief Summary
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Detailed Description
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A sample of 162 military healthcare beneficiaries (within the Kaiserslautern Military Community footprint) with complaints of poor sleep quality will be instructed to wear sleep actigraphy monitors and complete daily sleep diaries upon waking for a total of four weeks. On weeks 3 and 4, participants will use BET at bedtime for a minimum of 30 minutes. Pre and post sleep quality measures will be compared along with pre- and post- c-reactive protein (CRP) measures and a post-study questionnaire to assess participants' perception about the technology.
Conditions
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Keywords
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Study Design
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NA
SINGLE_GROUP
SUPPORTIVE_CARE
NONE
Study Groups
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Pre and Post Intervention
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.
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.
Interventions
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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.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
Exclusion Criteria
* 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
18 Years
ALL
Yes
Sponsors
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Landstuhl Regional Medical Center
FED
Responsible Party
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Dr MeLisa Gantt
(former) Chief, CNSCI
Principal Investigators
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MeLisa Gantt, PhD
Role: PRINCIPAL_INVESTIGATOR
Gantt Clinical Institute LLC
Locations
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Landstuhl Regional Medical Center
Landstuhl, , Germany
Countries
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Other Identifiers
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M-10544
Identifier Type: -
Identifier Source: org_study_id