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

Primary Purpose

Sleep, Sleep Disorders, Sleep Deprivation

Status
Terminated
Phase
Not Applicable
Locations
Germany
Study Type
Interventional
Intervention
Brain Entrainment Technology
Sponsored by
Landstuhl Regional Medical Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Sleep focused on measuring complementary and alternative medicine, military, binaural beat technology, brain entrainment technology, sleep

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • Landstuhl Regional Medical Center

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Pre and Post Intervention

Arm Description

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.

Outcomes

Primary Outcome Measures

"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.

Secondary Outcome Measures

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
"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.
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,
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.
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.
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.

Full Information

First Posted
March 7, 2017
Last Updated
November 27, 2017
Sponsor
Landstuhl Regional Medical Center
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1. Study Identification

Unique Protocol Identification Number
NCT03169309
Brief Title
The BEST Study: The Efficacy of Brain Entrainment Sleep Technology in Military Healthcare Beneficiaries
Acronym
BEST
Official Title
The BEST Study: The Efficacy of Brain Entrainment Sleep Technology in Military Healthcare Beneficiaries
Study Type
Interventional

2. Study Status

Record Verification Date
November 2017
Overall Recruitment Status
Terminated
Why Stopped
Study modified to a two-group crossover design and transferred to new location.
Study Start Date
January 2017 (Actual)
Primary Completion Date
September 2017 (Actual)
Study Completion Date
September 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Landstuhl Regional Medical Center

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
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

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Model Description
Pre- and post- intervention trial
Masking
None (Open Label)
Allocation
N/A
Enrollment
7 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Pre and Post Intervention
Arm Type
Experimental
Arm Description
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.
Intervention Type
Device
Intervention Name(s)
Brain Entrainment Technology
Other Intervention Name(s)
Binaural Beat Technology
Intervention Description
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.
Primary Outcome Measure Information:
Title
"Quantitative" Sleep Quality (via Sleep Actigraphy Watch)
Description
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.
Time Frame
Daily over the course of 4 weeks
Secondary Outcome Measure Information:
Title
Insomnia Severity Level (via Insomnia Severity Index Questionnaire)
Description
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
Time Frame
Baseline
Title
"Qualitative" Sleep Quality (via Sleep Foundation Sleep Diary Questionnaire)
Description
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.
Time Frame
Daily over the course of 4 weeks
Title
Overall Impression of Sleep Quality (via Pittsburgh Sleep Quality Index Questionnaire)
Description
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,
Time Frame
Baseline and Week 4 (after using intervention)
Title
Inflammatory Biomarker (via C-Reactive Protein Lab)
Description
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.
Time Frame
Baseline and Week 4 (after using intervention)
Title
Extenuating Factor Affecting C-Reactive Protein Level (via C-Reactive Protein Questionnaire)
Description
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.
Time Frame
Baseline and Week 4 (after using intervention)
Title
Overall Impression of Brain Entrainment Technology (via Post Study Questionnaire)
Description
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.
Time Frame
Week 4 (after using intervention)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
MeLisa Gantt, PhD
Organizational Affiliation
Gantt Clinical Institute LLC
Official's Role
Principal Investigator
Facility Information:
Facility Name
Landstuhl Regional Medical Center
City
Landstuhl
Country
Germany

12. IPD Sharing Statement

Plan to Share IPD
No

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

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