High-Resolution, Relational, Resonance-Based, Electroencephalic Mirroring (HIRREM) for Vasomotor Symptoms (Hot Flashes) in Perimenopausal and Postmenopausal Women: A Randomized, Controlled Clinical Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 8
- 试验地点
- 2
- 主要终点
- Reduction in Hot Flash Severity Score Based on Diary Data
研究概览
简要总结
The purpose of this research study is to determine the effects of a technique called High-resolution, relational, resonance-based, electroencephalic mirroring (HIRREM®), for women in any stage of menopause, who are experiencing menopause-related hot flashes.
详细描述
The purpose of this research study is to determine the effects of a technique called High-resolution, relational, resonance-based, electroencephalic mirroring (HIRREM®), for hot flashes. HIRREM uses scalp sensors to monitor brain electrical activity, and computer software algorithms translate selected brain frequencies into audible tones in real time. Those tones are reflected back to participants via ear buds in as little as four to eight milliseconds, providing the brain an opportunity for self-adjustment of its electrical pattern.
This study will compare acoustic stimulation linked to brainwave activity (HIRREM, along with continued current care, HCC), with continued current clinical care alone (CCC). Both groups will continue their other current care throughout, including non-pharmacological, and lifestyle modification therapies.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Supportive Care
- 盲法
- None
入排标准
- 年龄范围
- 40 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Women, age 40 and above
- •Intact uterus and ovaries
- •Have at least 5 hot flashes per day (with at least one being categorized as moderate to severe, in a stable pattern for one month).
排除标准
- •Less than 5 hot flashes per day
- •Does not experience at least 1 moderate to severe hot flash per day
- •Unable, unwilling, or incompetent to provide informed consent
- •Physically unable to come to the study visits, or to sit comfortably in a chair for up to two hours
- •Known seizure disorder
- •Known or potential pregnancy (females with last menstrual period less than one year from enrollment will be tested for pregnancy prior to randomization)
- •Severe hearing impairment (because the subject will be using headphones during the interventions)
- •Ongoing need for treatment with opiate, benzodiazepine, or anti-psychotic medications, anti-depressant medications such as SSRI, SNRI, or tricyclic, and sleep medications such as zolpidem or eszopiclone
- •Use of pharmaceuticals for treatment of vasomotor symptoms or any type of hormone replacement therapy
- •Use of supplements for improvement of vasomotor symptoms including but not limited to black cohosh, soy isoflavone extract, and red clover leaf extract
- •Menopausal symptoms resulting from, or associated with surgery, chemotherapy, radiation, or use of other chemicals or medications
- •Anticipated and ongoing use of recreational drugs, alcohol, or energy drinks
- •Ongoing need for treatment with thyroid medications
- •Weight is over the chair limit (285 pounds)
- •Are enrolled in another research study that includes an active intervention
- •Have previously received brainwave optimization (BWO), used a B2 or a B2v2 wearable device, or previously participated in a HIRREM research study
结局指标
主要结局
Reduction in Hot Flash Severity Score Based on Diary Data
时间窗: Baseline to V2 (4-6 weeks following completion of the intervention).
Both groups maintained a hot flash diary for 7-14 days, after which the intervention will begin for the HCC group. Post-intervention data collections will include an intermediate post-intervention visit (V2, primary outcome, 4-6 weeks after intervention completion for HCC, and 10-12 weeks after V1 for CCC), and a final follow up visit (V3, 12-14 weeks following completion of the intervention for HCC, and 18-20 weeks after V1 for CCC). Both groups will maintain a hot flash diary for 1-2 weeks prior to the V2 and V3 visits. The primary outcome will be change in hot flashes score from V1 to V2. The hot flash severity score for each day was calculated as the sum of the number of hot flashes within each severity category, multiplied by the severity score for that category, with the resulting sum divided by the total number of hot flashes. Scale ranges from 0 (no hot flashes) to an open ended upper number (no max since participant dependent). A higher number suggest worse hot flashes.
次要结局
- Change in Center for Epidemiologic Studies Depression Scale (CES-D)(Baseline to V2 (4-6 weeks following completion of the intervention).)
- Change in Insomnia Severity Index (ISI)(Baseline to V2 (4-6 weeks following completion of the intervention).)
- Change in Baroreflex Sensitivity(Baseline to V2 (4-6 weeks following completion of the intervention).)
- Change in Pittsburgh Sleep Quality Index (PSQI)(Baseline to V2 (4-6 weeks following completion of the intervention).)
- Change in Epworth Sleepiness Score (ESS)(Baseline to V2 (4-6 weeks following completion of the intervention).)
- Change in Drop Stick Reaction Time(Baseline to V2 (4-6 weeks following completion of the intervention).)
- Change in Hot Flash Related Daily Interference Scale (HFRDIS)(Baseline to V2 (4-6 weeks following completion of the intervention).)
- Change in Perceived Stress Scale (PSS)(Baseline to V2 (4-6 weeks following completion of the intervention).)
- Change in Heart Rate Variability(Baseline to V2 (4-6 weeks following completion of the intervention).)
- Change in Generalized Anxiety Disorder-7 (GAD-7)(Baseline to V2 (4-6 weeks following completion of the intervention).)
- Change in Grip Strength(Baseline to V2 (4-6 weeks following completion of the intervention).)
- Change in Quality of Life Scale (QOLS)(Baseline to V2 (4-6 weeks following completion of the intervention).)
- Change in Menopause Rating Scale (MRS)(Baseline to V2 (4-6 weeks following completion of the intervention).)