The Sound Mind Warrior Study

May 25, 2017 updated by: LTC MeLisa Gantt, Fort Belvoir Community Hospital

Binaural Beat Technology: A Complementary Path to Post Deployment Wellness (The Sound Mind Warrior Study)

The purpose of this prospective, double-blind, repeated measures study is to assess the efficacy of Binaural Beat Technology (BBT) on anxiety and anxiety related cardiovascular measures as well as to assess the feasibility of implementing a BBT intervention in a military population during the high risk post-deployment window.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

The purpose of this prospective, double-blind, repeated measures study is to assess the efficacy of Binaural Beat Technology (BBT- a sound technology that uses special tones [embedded in music] through stereo headphones to affect your brainwaves in order to put you in a more relaxed state) on anxiety and anxiety related cardiovascular measures as well as to assess the feasibility of implementing a BBT intervention in a military population during the high risk post-deployment window.

A sample of 74 Warriors who have deployed will be randomly placed into two groups (music with BBT and music without BBT). Each group will be exposed to their respective intervention for 30 minutes at bedtime, 3 times a week, for 4 weeks. Quantitative and qualitative measures will be collected as follows…

  1. Cardiovascular reactivity, c-reactive protein, and state anxiety measures will be collected at baseline and after the 4 week intervention.
  2. Morning blood pressure (BP) surge and evening BP decline measures will be collected at baseline and weeks 0, 2 and 4.
  3. Input from the participants will be collected via daily logs and at the completion of the 4 week intervention.

Aim 1 - To assess the feasibility of implementing a binaural beat technology intervention in a military population during the high risk post deployment window. Feasibility will be measured by assessing:

  1. retention
  2. number of refusal during recruitment
  3. number of drop outs
  4. reason for drop outs
  5. reason for staying
  6. number of days the technology was used
  7. selection of music
  8. ease of use and comfort of equipment
  9. adherence to the protocol
  10. evaluation of recruitment strategies

Aim 2 - To assess the impact of binaural beat technology on anxiety and relevant CV health measures. These measures included:

  1. Comparison of pre and post intervention state anxiety scores
  2. Observing the trend of morning blood pressure surge over time
  3. Observing the trend of evening blood pressure decline over time
  4. Comparison of pre and post intervention heart rate variability measures
  5. Comparison of pre and post intervention c-reactive protein measures

Study Type

Interventional

Enrollment (Actual)

74

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Maryland
      • Bethesda, Maryland, United States, 20889
        • Walter Reed National Military Medical Center
    • Virginia
      • Fort Belvoir, Virginia, United States, 22060
        • Fort Belvoir Community Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Military personnel who

    1. Have deployed
    2. Are eligible to receive healthcare at WRNMMC or FBCH
    3. Are 18 years and older

    4. Are able to commit to a 5-week study

      Exclusion Criteria:

  • Military personnel who…

    1. Are taking any medication in the anti-hypertensive category
    2. Are taking any medication in the anti-anxiety category
    3. Have been diagnosed with moderate or severe traumatic brain injury
    4. Have a history of epilepsy
    5. Are taking any medication in the anti-seizure category
    6. Have hearing deficit and/or wear a hearing aide

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Music with BBT
Music embedded with special tones.
Other: Binaural Beat Technology
A phenomenon when two nearly similar frequencies (between 30-1000 hertz [Hz]) are presented to each ear and the brain detects the difference between the two sounds. These two sounds are processed in the superior olivary nucleus of each hemisphere of the brain. This integration of brain hemispheres produces a frequency that in turn affects the reticular activating system which alters the electrical potentials of the thalamus and cerebral cortex changing brainwave frequency.
Other Names:
  • Hemi-Sync
Placebo Comparator: Music without BBT
Music not embedded with special tones.
Other: Binaural Beat Technology
A phenomenon when two nearly similar frequencies (between 30-1000 hertz [Hz]) are presented to each ear and the brain detects the difference between the two sounds. These two sounds are processed in the superior olivary nucleus of each hemisphere of the brain. This integration of brain hemispheres produces a frequency that in turn affects the reticular activating system which alters the electrical potentials of the thalamus and cerebral cortex changing brainwave frequency.
Other Names:
  • Hemi-Sync

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
C-Reactive Protein
Time Frame: Before the intervention and again at 5 weeks
C-reactive protein is a biomarker of the inflammatory process.
Before the intervention and again at 5 weeks
State-Trait Anxiety (STAI)
Time Frame: Before the intervention and again at 5 weeks
The STAI will be used to measure overall generalized anxiety as well as current state anxiety immediately before and after the intervention. The instrument consists of 40 4-point Likert scale statements (20 related to trait anxiety and 20 related to state anxiety). Scores range from 40 to 160 with the higher score depicting a higher level of anxiety.
Before the intervention and again at 5 weeks
Morning Blood Pressure/Evening Blood Pressure Decline
Time Frame: Before the intervention, at 2 weeks and again at 4 weeks
Using an ambulatory blood pressure (BP) monitor, BP measures will be taken every 60 minutes starting from two hours before bedtime and ending two hours after rising. Morning BP surge will be assessed by comparing the trend of the number of millimeters of mercury (mm Hg) the BP increased during the first two hours after rising. Evening BP decline will be assessed by comparing the trend of the percentage that the BP declined while sleep when compared the mean awake BP.
Before the intervention, at 2 weeks and again at 4 weeks
Cardiovascular Reactivity
Time Frame: Before the intervention and again at 5 weeks
Continuous heart rate measures will be taken during five states: 1) at baseline, 2) during the training for a cognitive challenge, 3) during the cognitive challenge, 4) during recovery, and 5) when verbally coached to relax. When analyzed via the computer, a high variability response will indicate a healthy autonomic system whereas a low variability response will indicate evidence of chronic stress exposure.
Before the intervention and again at 5 weeks
Post Intervention Questionnaire
Time Frame: At 5 weeks
The Post Intervention Questionnaire will be used to collect qualitative data (3 questions to address efficacy and 11 questions to address feasibility). This instrument will be used in conjunction with field notes during recruitment to assess: 1) retention, 2) number of refusal during recruitment, 3) number of drop outs, 4) reason for drop out, 5) reason for staying, 6) number of day the technology was used (more or less than prescribed recommendation), 7) selection of music, 8) ease of use and comfort of equipment (e.g., sleep phone, mp3 player, etc), 9) adherence to the protocol, and 10) evaluation of recruitment strategies.
At 5 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Fort Belvoir Community Hospital

Collaborators

Walter Reed National Military Medical Center
TriService Nursing Research Program

Investigators

  • Principal Investigator: MeLisa Gantt, PhD, Gantt Clinical Research Institute LLC

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 2012

Primary Completion (Actual)

July 1, 2015

Study Completion (Actual)

July 1, 2015

Study Registration Dates

First Submitted

December 18, 2014

First Submitted That Met QC Criteria

December 29, 2014

First Posted (Estimate)

December 31, 2014

Study Record Updates

Last Update Posted (Actual)

May 30, 2017

Last Update Submitted That Met QC Criteria

May 25, 2017

Last Verified

May 1, 2017

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • 361395

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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