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SleepBESTNCT03169309

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

A study testing Brain Entrainment Technology in people with Sleep and Sleep Disorders, run by Landstuhl Regional Medical Center at 1 site in Germany.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
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Trial 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… Read more about this study

Who is it for?
Ages 18 years and olderHealthy volunteers can take part
Conditions the study is for
Sleep, Sleep Disorders, Sleep Deprivation
What is being tested?
Brain Entrainment Technology
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
7 participants
Where
1 siteGermany
Study dates
Jan 2017to Sep 2017
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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
Show all 10Show fewer
  • 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

Trial locations and contacts

1 site in 1 country.

Germany1 site

  • Landstuhl Regional Medical Center

    Landstuhl

Other trials in Germany

About this study

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.

Read the 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.

Being tested
Brain Entrainment Technology
Keywords
complementary and alternative medicine, military, binaural beat technology, brain entrainment technology, sleep
Medical subject headings
Sleep Wake Disorders, Sleep Deprivation, Parasomnias, Sleep Disorders, Intrinsic, Sleep Disorders, Circadian Rhythm

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Brain Entrainment TechnologyDevice

    Also called Binaural Beat 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.

Study groups in NCT03169309
Study groupRoleWhat they receive
Pre and Post InterventionExperimentalOne 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.
Receives: Device: Brain Entrainment Technology

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

    Measured: Daily over the course of 4 weeks

Secondary outcomes (6)

  1. 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

    Measured: Baseline

  2. "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.

    Measured: Daily over the course of 4 weeks

  3. 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,

    Measured: Baseline and Week 4 (after using intervention)

  4. 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.

    Measured: Baseline and Week 4 (after using intervention)

  5. 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.

    Measured: Baseline and Week 4 (after using intervention)

  6. 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.

    Measured: Week 4 (after using intervention)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted30 May 2017
  2. Study startJan 2017
  3. Primary completionSep 2017
  4. Study completionSep 2017

Why it stopped: Study modified to a two-group crossover design and transferred to new location.

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Supportive care
Allocation
Not applicable
Intervention model
Single group
Model description
Pre- and post- intervention trial
Masking
None (open label)
Enrolment
7 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03169309
Sponsor's protocol ID
M-10544
Acronym
BEST
Status last verified
Nov 2017
First submitted
7 Mar 2017
Last updated
29 Nov 2017
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A study testing Brain Entrainment Technology in people with Sleep and Sleep Disorders, run by Landstuhl Regional Medical Center at 1 site in Germany.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: stopped early, as of the sponsor's last update on 29 Nov 2017. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study was stopped early (reason given: Study modified to a two-group crossover design and transferred to new location.). Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

"Quantitative" Sleep Quality (via Sleep Actigraphy Watch) (time frame: Daily over the course of 4 weeks). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03169309.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Nov 2017.

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