Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu

The Sound Mind Warrior Study

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02328690
Recruitment Status : Completed
First Posted : December 31, 2014
Last Update Posted : May 30, 2017
Sponsor:
Collaborators:
Walter Reed National Military Medical Center
TriService Nursing Research Program
Information provided by (Responsible Party):
LTC MeLisa Gantt, Fort Belvoir Community Hospital

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Anxiety Stress Other: Binaural Beat Technology Not Applicable

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

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 74 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: Binaural Beat Technology: A Complementary Path to Post Deployment Wellness (The Sound Mind Warrior Study)
Study Start Date : June 2012
Actual Primary Completion Date : July 2015
Actual Study Completion Date : July 2015

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Anxiety

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 Name: 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 Name: Hemi-Sync




Primary Outcome Measures :
  1. C-Reactive Protein [ Time Frame: Before the intervention and again at 5 weeks ]
    C-reactive protein is a biomarker of the inflammatory process.

  2. 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.

  3. 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.

  4. 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.

  5. 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.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02328690


Locations
Layout table for location information
United States, Maryland
Walter Reed National Military Medical Center
Bethesda, Maryland, United States, 20889
United States, Virginia
Fort Belvoir Community Hospital
Fort Belvoir, Virginia, United States, 22060
Sponsors and Collaborators
Fort Belvoir Community Hospital
Walter Reed National Military Medical Center
TriService Nursing Research Program
Investigators
Layout table for investigator information
Principal Investigator: MeLisa Gantt, PhD Gantt Clinical Research Institute LLC
Layout table for additonal information
Responsible Party: LTC MeLisa Gantt, (former) Chief, Research Program, Fort Belvoir Community Hospital
ClinicalTrials.gov Identifier: NCT02328690    
Other Study ID Numbers: 361395
First Posted: December 31, 2014    Key Record Dates
Last Update Posted: May 30, 2017
Last Verified: May 2017
Keywords provided by LTC MeLisa Gantt, Fort Belvoir Community Hospital:
binaural beat technology
sound technology
cardiovascular stress response
military
music
anxiety
stress