Use of Bioboosti Non-pharmacologic Device for Insomnia Treatment: A Pilot Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 20
- 试验地点
- 2
- 主要终点
- Insomnia Severity Index
研究概览
简要总结
The purpose of this study is to determine the effects of the Bioboosti device on sleep for patients who have been diagnosed with insomnia.
详细描述
Insomnia is a common health complaint that is associated with discomfort, loss of productivity, poor health and higher use of healthcare. The use of non-pharmacologic treatments for insomnia has gained much attention in recent years. The investigators are conducting this research because a safe, non-pharmacologic treatment would benefit patients with insomnia, and to see if the Bioboosti device is an effective treatment for insomnia.
Subjects will include patients from the clinics who have the diagnosis of insomnia. Study staff will notify the treating physician of a potential subject. If the subject gives permission and would like to obtain more information, study staff will approach them and provide them with the consent form to review. Study staff may also contact them by phone to explain the study and recruit.
Subjects will be asked to make 5 visits:
Visit 1-- consent form, physical exam, vitals, pregnancy test, sleep log
Visit 2-- sleep questionnaires, urine test for hormones associated with sleep, sleep log, placement of EEG
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Sequential
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients with insomnia
排除标准
- •Untreated moderate or severe sleep apnea
- •Major circadian rhythm disorder
- •Pregnant women
- •Breastfeeding
- •Cardiac pacemaker
- •Severe conditions related to heart, brain, kidney and hematopoietic system
- •Severe/unstable angina pectoris
- •Arteria coronaria/ peripheral arterial bypass graft
- •Acute congestive heart failure
- •Renal insufficiency
- •Mechanical intestinal obstruction
- •Any electrical devices
研究组 & 干预措施
Bioboosti
Treatment with the Bioboosti device for two weeks. The device produces a pulsed micro-magnetic field. Subjects will use it once a day for about one hour, before habitual sleep time.
干预措施: Bioboosti (Device)
Sustained Efficacy
Treatment with Bioboosti device for a year. In order to see if the device has sustained efficacy in treating insomnia.
Subjects will use it once a day for about one hour, before habitual sleep time.
干预措施: Bioboosti (Device)
Insomnia and migraine
Treatment with the Bioboosti device for a month. Subjects will use it once a day for about one hour, before habitual sleep time.
干预措施: Bioboosti (Device)
结局指标
主要结局
Insomnia Severity Index
时间窗: Baseline to 2 weeks
Change in Insomnia Severity Index (ISI) will be measured. The Insomnia Severity Index (ISI) is a short, 7-item self-report questionnaire used to screen for insomnia, assess its severity, and monitor treatment effectiveness by evaluating sleep problems (like falling/staying asleep, early waking) and their impact on daytime functioning over the past two weeks. Scoring from 0 to 28, with higher scores indicating greater severity, the ISI helps classify insomnia as none, subthreshold, moderate, or severe, guiding clinical decisions in research and practice. This will be done before and after treatment.
Pittsburgh Sleep Quality Index
时间窗: Baseline to 2 weeks
The change in the Pittsburgh Sleep Quality Index (PSQI) from baseline to 2 weeks will be measured. The PSQI is a widely used, self-rated questionnaire that assesses sleep quality and disturbances over a one-month period. It consists of 19 items that generate seven component scores (subjective sleep quality, sleep latency, sleep duration, habitual sleep efficiency, sleep disturbances, use of sleeping medication, and daytime dysfunction), which are summed to yield a global score ranging from 0 to 21. Higher global scores indicate worse sleep quality. Change will be calculated as the PSQI score at 2 weeks minus the PSQI score at baseline (Week 2 - Baseline). Because lower PSQI scores indicate better sleep quality, a negative change score reflects an improvement in sleep quality, whereas a positive change score reflects worsening sleep quality.
Daytime Sleepiness
时间窗: Baseline to 2 weeks
Daytime sleepiness will be assessed using a Visual Analog Scale (VAS) from baseline to 2 weeks. The VAS is a subjective measure consisting of a 100 mm horizontal line anchored by "not at all sleepy" (0 mm) on the left and "extremely sleepy" (100 mm) on the right. Participants mark the point on the line that best represents their current level of daytime sleepiness. Higher scores indicate greater sleepiness. Change will be calculated as the VAS score at 2 weeks minus the VAS score at baseline (Week 2 - Baseline). Because higher scores indicate greater sleepiness, a negative change score reflects a reduction in daytime sleepiness (improvement), whereas a positive change score reflects an increase in daytime sleepiness (worsening). The mean change and standard deviation of the change scores will be reported.
次要结局
未报告次要终点
研究者
Pavlova, Milena,M.D.
Medical Doctor
Brigham and Women's Hospital