High-resolution, Relational, Resonance-based, Electroencephalic Mirroring (HIRREM) to Relieve Insomnia: A Randomized, Placebo-Controlled Clinical Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 107
- 试验地点
- 1
- 主要终点
- Change From Baseline in Insomnia Severity Index (ISI)
研究概览
简要总结
The purpose of this study is to determine whether the addition of High-resolution, relational, resonance-based, electroencephalic mirroring (HIRREM) to usual care will improve insomnia symptoms based on changes in the Insomnia Severity Index at two months following completion of the intervention, compared to placebo plus usual care.
详细描述
Insomnia is the most prevalent sleep disorder and is associated with significant psychosocial and somatic pathology. Effective noninvasive interventions for insomnia are lacking. High-resolution, relational, resonance-based, electroencephalic mirroring (HIRREM), is a noninvasive, brain feedback technology to facilitate relaxation and auto-calibration of neural oscillations by using auditory tones to reflect brain frequencies in near real time. An open label, randomized, crossover pilot trial showed that HIRREM was safe and effective, with significant benefits for individuals with moderate to severe insomnia, based on differential change with symptoms of insomnia (Insomnia Severity Index, ISI). This study will extend those results in a larger cohort using a single blind, placebo controlled study design.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Moderate to severe clinical insomnia (Insomnia Severity Index score of 15 or higher)
排除标准
- •Unable, unwilling, or incompetent to provide informed consent
- •Physically unable to come to the study visits
- •Known obstructive sleep apnea
- •Diagnosed periodic limb movement disorder or known restless legs syndrome
- •Known seizure disorder
- •Known urinary problem (i.e. benign prostatic hypertrophy) which is the likely cause of the sleep disturbance
- •Severe hearing impairment
- •Known, or suspected diagnosis of post-traumatic stress disorder (PTSD)
- •Known, relevant traumatic brain injury (TBI)
- •Ongoing need for treatment with opiate, benzodiazepine, or anti-psychotic medications, anti-depressant medications such as SSRI, SNRI, or tricyclics, and sleep medications such as zolpidem or eszopiclone
- •Anticipated and ongoing use of recreational drugs or alcohol
- •Lack of internet or smart phone access
研究组 & 干预措施
HIRREM
High-resolution, relational, resonance-based, electroencephalic mirroring (HIRREM) is a novel, noninvasive, electroencephalic-based feedback technology to facilitate relaxation and auto-calibration of neural oscillations by using auditory tones to reflect brain frequencies in near real time.
干预措施: HIRREM (Device)
Placebo
Subjects in this arm will receive a sham-HIRREM placebo, for which the scalp sensors have no active recording capability, and for which the auditory tonal feedback is randomly generated rather than based on current brain frequencies and amplitudes.
干预措施: HIRREM (Device)
结局指标
主要结局
Change From Baseline in Insomnia Severity Index (ISI)
时间窗: Collected from the enrollment visit through completion of the primary data collection visit, 8-10 weeks after completion of the intervention
The ISI is a 7 question, self-reported measure to evaluate symptoms of insomnia, with responses from 0-4 for each question, yielding scores ranging from 0-28. Lower scores represent better outcomes. The primary outcome will be change from enrollment to 8-10 weeks after completion of the intervention.
次要结局
- Change From Baseline in EQ-5D(Collected from the enrollment visit through completion of the primary data collection visit, 8-10 weeks after completion of the intervention)
- Change in Total Sleep Time (TST)(Collected from the enrollment visit through completion of the primary data collection visit, 8-10 weeks after completion of the intervention)
- Change From Baseline in Beck Depression Inventory - II (BDI-II)(Collected from the enrollment visit through completion of the primary data collection visit, 8-10 weeks after completion of the intervention)
- Change in RestRefresh and SleepQual(Collected from the enrollment visit through completion of the primary data collection visit, 8-10 weeks after completion of the intervention)
- Change in Heart Rate Variability (HRV)(Collected from the enrollment visit through completion of the primary data collection visit, 8-10 weeks after completion of the intervention)
- Change From Baseline in Sleep Onset Latency and Wake After Sleep Onset(Baseline and 8-10 weeks after completion of intervention)
- Change From Baseline in Beck Anxiety Inventory (BAI)(Collected from the enrollment visit through completion of the primary data collection visit, 8-10 weeks after completion of the intervention)
- Change in Baroflex Sensitivity (BRS)(8-10 weeks after completion of the intervention)