NCT03169309

The BEST Study: The Efficacy of Brain Entrainment Sleep Technology in Military Healthcare Beneficiaries

• Status: Terminated
• Phase: N/A
• Study type: Interventional
• Enrollment: 7 (actual)
• Sponsor: Landstuhl Regional Medical Center · Federal
• Sex: All
• Age: 18 Years
• Healthy volunteers: Accepted

Summary

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.

Detailed description

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.

Conditions

• Sleep
• Sleep Disorders
• Sleep Deprivation
• Sleep Disturbance
• Sleep Disorders, Intrinsic
• Sleep Disorders, Circadian Rhythm

Interventions

Type	Name	Description
DEVICE	Brain Entrainment Technology	Brain Entrainment Technology (BET), also known as Binaural Beat Technology (BBT), is a sound technology where two slightly different tones are present to each ear and the brain produces a third tone. This third tone impacts the reticular activating system which alters the action potentials of the thalamus and cerebral cortex in turn changing the brain wave frequency to alter the state of consciousness of the listener.

Timeline

• Start date: 2017-01-01
• Primary completion: 2017-09-01
• Completion: 2017-09-01
• First posted: 2017-05-30
• Last updated: 2017-11-29

Locations

1 site across 1 country: Germany