The BEST Study: The Efficacy of Brain Entrainment Sleep Technology in Military Healthcare Beneficiaries
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 发起方
- 入组人数
- 7
- 试验地点
- 1
- 主要终点
- "Quantitative" Sleep Quality (via Sleep Actigraphy Watch)
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Supportive Care
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Score greater than or equal to 15 on the Insomnia Severity Index (ISI)
- •Affiliated with at least one of the 13 installations within the Kaiserslautern Military Community (KMC) area
- •Eligible to receive healthcare at Landstuhl Regional Medical Center (LRMC)
- •Are 18 years or older
- •Can read and speak English
- •Are able to commit to a 4 week study
排除标准
- •Are taking any type of medication that causes drowsiness
- •Have been diagnosed with moderate to severe traumatic brain injury (TBI)
- •Have a history of epilepsy
- •Are taking any medication in the anti-seizure category
- •Have been diagnosed with, taking medication for, or are currently being evaluated for a psychological health issue as defined by the Diagnostic and Statistical Manual of Mental Disorders, 5th Edition (DSM-5) that will prohibit them from using intervention as perscribed.
- •Have ear trauma, difficulty hearing or wear a hearing aide
- •Have a chronic inflammatory health issue
- •Are pregnant or are trying to become pregnant in the next 4 weeks
- •*Women of child bearing age will be asked to provide a urine sample for a pregnancy test
- •Are currently using BET
研究组 & 干预措施
Pre and Post Intervention
One Study Arm - Quantitative and qualitative sleep quality measure will be captured at baseline (Phase I/Week 1-2), while using Brain Entrainment Technology (Phase II/Week3-4), and after using the technology.
干预措施: Brain Entrainment Technology (Device)
结局指标
主要结局
"Quantitative" Sleep Quality (via Sleep Actigraphy Watch)
时间窗: Daily over the course of 4 weeks
Sleep actigraphy monitor will measure wake/sleep. Using special software, that information is then articulated into graphical and tabulated report that shows the movement that occurred throughout the wake and sleep cycles as well as light exposure that may have affected sleep. The report gives the a) time the participants went to bed, b) time they woke up, c) number of hours they were in the bed, d) total number of hours asleep, e) number of minutes it took to fall asleep, f) percent efficiency of their sleep, g) number of minutes awaken after sleep onset, and h) total number of times they woke up after falling asleep.
次要结局
- Insomnia Severity Level (via Insomnia Severity Index Questionnaire)(Baseline)
- "Qualitative" Sleep Quality (via Sleep Foundation Sleep Diary Questionnaire)(Daily over the course of 4 weeks)
- Inflammatory Biomarker (via C-Reactive Protein Lab)(Baseline and Week 4 (after using intervention))
- Overall Impression of Sleep Quality (via Pittsburgh Sleep Quality Index Questionnaire)(Baseline and Week 4 (after using intervention))
- Extenuating Factor Affecting C-Reactive Protein Level (via C-Reactive Protein Questionnaire)(Baseline and Week 4 (after using intervention))
- Overall Impression of Brain Entrainment Technology (via Post Study Questionnaire)(Week 4 (after using intervention))
研究者
Dr MeLisa Gantt
(former) Chief, CNSCI
Landstuhl Regional Medical Center