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

Study Overview
=================
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.

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

Conditions
-----------------
Sleep, Sleep Disorders, Sleep Deprivation, Sleep Disturbance, Sleep Disorders, Intrinsic, Sleep Disorders, Circadian Rhythm

Intervention / Treatment
-----------------
* Device: Brain Entrainment Technology


Participation Criteria
=================
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

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Supportive Care
Intervention Model: Single Group Assignment
Interventional Model Description: Pre- and post- intervention trial
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Pre and Post Intervention<br>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<br>* 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.<br>* Other names: Binaural Beat Technology;|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Insomnia Severity Level (via Insomnia Severity Index Questionnaire) | A 7-item questionnaire will be used as a screening tool to quantify the severity level of the participant's poor sleep quality. It is comprised of a 5-point Likert scale with a total score from 0-28 with 15 or greater indicating moderate to severe insomnia | Baseline | 
| Qualitative Sleep Quality (via Sleep Foundation Sleep Diary Questionnaire) | A 14-item questionnaire will be used to capture sleep habits. Questions cover: napping, caffeine, alcohol, exercise, medication, meals, sleepiness, sleep hygiene, and quality. This instrument is not scored but merely used to assess patterns and if those patterns changed over the course of the study. | Daily over the course of 4 weeks | 
| Overall Impression of Sleep Quality (via Pittsburgh Sleep Quality Index Questionnaire) | A 24-item item questionnaire gives an accumulative score based on sub scores of sleep duration, sleep disturbance, sleep latency, number of days of dysfunction due to sleepiness, sleep efficiency, sleep quality, and medication usage. Minimum Score = 0 (better); Maximum Score = 21 (worse). Interpretation: TOTAL < 5 associated with good sleep quality and TOTAL > 5 associated with poor sleep, | Baseline and Week 4 (after using intervention) | 
| Inflammatory Biomarker (via C-Reactive Protein Lab) | A blood sample for c-reactive protein will measures the inflammatory process. After accounting for any external influences on CRP level, this measure will be correlated with the objective and subjective sleep data to assess if changes in sleep quality affected the inflammatory response. | Baseline and Week 4 (after using intervention) | 
| Extenuating Factor Affecting C-Reactive Protein Level (via C-Reactive Protein Questionnaire) | Since exposure to stress, infection, allergy, injury, or menstruation could affect CRP levels; this 6-item questionnaire will be used to note other possible co-variates that could have impacted CRP levels. | Baseline and Week 4 (after using intervention) | 
| Overall Impression of Brain Entrainment Technology (via Post Study Questionnaire) | A 10-item questionnaire will be used at the completion of the study to instrument will capture any subjective comments from the participants as to assess the participant's perception about the technology as well as to assess ways that will help improve future studies using the same equipment and/or technology. | Week 4 (after using intervention) | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
complementary and alternative medicine, military, binaural beat technology, brain entrainment technology, sleep