Clinical trial NCT03169309: The BEST Study: The Efficacy of Brain Entrainment Sleep Technology in Military Healthcare Beneficiaries
Official title: The BEST Study: The Efficacy of Brain Entrainment Sleep Technology in Military Healthcare Beneficiaries
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
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
Lead sponsor: Landstuhl Regional Medical Center
Sponsor class: FED
First posted: 2017-05-30
Enrollment: 7
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Pre- and post- intervention trial
Primary purpose: SUPPORTIVE_CARE

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.

Detailed description: This study will follow a prospective, one group pre- and post-intervention design.

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.

Eligibility criteria: Inclusion Criteria:

* 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

Exclusion Criteria:

* 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

Primary outcomes:
measure: "Quantitative" Sleep Quality (via Sleep Actigraphy Watch)
timeFrame: Daily over the course of 4 weeks
Secondary outcomes:
measure: Insomnia Severity Level (via Insomnia Severity Index Questionnaire)
timeFrame: Baseline
measure: "Qualitative" Sleep Quality (via Sleep Foundation Sleep Diary Questionnaire)
timeFrame: Daily over the course of 4 weeks
measure: Overall Impression of Sleep Quality (via Pittsburgh Sleep Quality Index Questionnaire)
timeFrame: Baseline and Week 4 (after using intervention)
measure: Inflammatory Biomarker (via C-Reactive Protein Lab)
timeFrame: Baseline and Week 4 (after using intervention)
measure: Extenuating Factor Affecting C-Reactive Protein Level (via C-Reactive Protein Questionnaire)
timeFrame: Baseline and Week 4 (after using intervention)
measure: Overall Impression of Brain Entrainment Technology (via Post Study Questionnaire)
timeFrame: Week 4 (after using intervention)
Other outcomes:
Locations:
city: Landstuhl
country: Germany
facility: Landstuhl Regional Medical Center
Study officials:
affiliation: Gantt Clinical Institute LLC
name: MeLisa Gantt, PhD
role: PRINCIPAL_INVESTIGATOR
References: