Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
74 participants
INTERVENTIONAL
2012-06-30
2015-07-31
Brief Summary
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Detailed Description
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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
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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Music with BBT
Music embedded with special tones.
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.
Music without BBT
Music not embedded with special tones.
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.
Interventions
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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 Intervention Names
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Eligibility Criteria
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Inclusion Criteria
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
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
18 Years
ALL
Yes
Sponsors
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Walter Reed National Military Medical Center
FED
TriService Nursing Research Program
OTHER
Fort Belvoir Community Hospital
FED
Responsible Party
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LTC MeLisa Gantt
(former) Chief, Research Program
Principal Investigators
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MeLisa Gantt, PhD
Role: PRINCIPAL_INVESTIGATOR
Gantt Clinical Research Institute LLC
Locations
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Walter Reed National Military Medical Center
Bethesda, Maryland, United States
Fort Belvoir Community Hospital
Fort Belvoir, Virginia, United States
Countries
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Other Identifiers
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361395
Identifier Type: -
Identifier Source: org_study_id
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