The Sound Mind Warrior Study

Study Overview
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Brief Summary
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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.

Detailed Description
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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… Cardiovascular reactivity, c-reactive protein, and state anxiety measures will be collected at baseline and after the 4 week intervention. Morning blood pressure (BP) surge and evening BP decline measures will be collected at baseline and weeks 0, 2 and 4. 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: retention number of refusal during recruitment number of drop outs reason for drop outs reason for staying number of days the technology was used selection of music ease of use and comfort of equipment adherence to the protocol evaluation of recruitment strategies Aim 2 - To assess the impact of binaural beat technology on anxiety and relevant CV health measures. These measures included: Comparison of pre and post intervention state anxiety scores Observing the trend of morning blood pressure surge over time Observing the trend of evening blood pressure decline over time Comparison of pre and post intervention heart rate variability measures Comparison of pre and post intervention c-reactive protein measures

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

Conditions
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Anxiety, Stress

Intervention / Treatment
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* Other: Binaural Beat Technology


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Military personnel who Have deployed Are eligible to receive healthcare at WRNMMC or FBCH Are 18 years and older Are able to commit to a 5-week study Exclusion Criteria: Military personnel who… Are taking any medication in the anti-hypertensive category Are taking any medication in the anti-anxiety category Have been diagnosed with moderate or severe traumatic brain injury Have a history of epilepsy Are taking any medication in the anti-seizure category Have hearing deficit and/or wear a hearing aide

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Music with BBT<br>Music embedded with special tones. | Other: Binaural Beat Technology<br>* 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.<br>* Other names: Hemi-Sync;|
| Placebo Comparator: Music without BBT<br>Music not embedded with special tones. | Other: Binaural Beat Technology<br>* 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.<br>* Other names: Hemi-Sync;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| C-Reactive Protein | C-reactive protein is a biomarker of the inflammatory process. | Before the intervention and again at 5 weeks | 
| State-Trait Anxiety (STAI) | 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 | 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 | 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 | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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music, binaural beat technology, sound technology, cardiovascular stress response, military, anxiety, stress