Sleep Clinical Trial
Official title:
The BEST Study: The Efficacy of Brain Entrainment Sleep Technology in Military Healthcare Beneficiaries
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.
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.
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