Cereset Research for Caregivers: A Randomized, Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 20
- 试验地点
- 2
- 主要终点
- Change in Blood Pressure Measurements
研究概览
简要总结
Caregivers experience high levels of prolonged stress that can lead to chronic problems with health, including increased risk of cardiovascular disease that is linked to autonomic dysregulation. Heart rate variability (HRV), measures of autonomic cardiovascular regulation, is decreased (worse) in caregivers. Autonomic function is linked to lateralization in the brain, and emerging neuromodulation methods that target lateralized signals in the brain, like Cereset (CR), may be able to improve heart rate variability. Therefore, this pilot study aims to test whether CR can improve HRV in caregivers of a person living with dementia experiencing stress, anxiety, or insomnia, as well as improve self-report measures of stress, sleep and caregiver burden.
详细描述
Phase I: Intervention only pre-piloting: up to 5 adults; mirroring Phase II characteristics described below
Phase II: 20 caregivers experiencing symptoms of stress, anxiety or insomnia. Primary aims are to:
1) Evaluate the effect of CR to improve autonomic cardiovascular regulation measured as heart rate variability (HRV) and baroreflex sensitivity (BRS). Impact will be assessed based on changes in standard measures of HRV and BRS such as SDNN, rMSSD, HF Alpha, and Sequence ALL. This will also provide blood pressure values evaluated by an automated oscillometric blood pressure device.
2) Assess the effect of CR on self-reported symptom inventories of stress, anxiety, insomnia, and caregiver burden and distress.
- Insomnia as assessed by the Insomnia Severity Index (ISI).
- Behavioral outcomes such as depression (as assessed by the Center for Epidemiological Studies-Depression Scale, CES-D), anxiety (as evaluated by the GAD-7), traumatic stress (as assessed by the PCL-C), and stress (as assessed by the Perceived Stress Scale, PSS).
- Overall quality of life as evaluated using the QOLS measure.
- Caregiver burden and distress measured with the Zarit Caregiver Burden scale and the Neuropsychiatric Inventory Questionnaire (NPI-Q).
- Brief (4-item) caregiver self-efficacy scale.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Single Group
- 主要目的
- Supportive Care
- 盲法
- Single (Participant)
盲法说明
Phase 1 - Participants will receive INT, there is no blinding.
Phase 2 - Participants will not be told which group they are assigned to until the end of the study.
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
- •Participants must provide caregiving at least 10 hours per week. This includes all types of caregiving
- •participants must be willing to provide informed consent
- •participants must be able to comply with basic instructions
- •participants must be able to sit comfortably for up to 90 minutes, and attend up to three 60-minute intervention sessions each week during the 4-week intervention period
- •participants must self report experiencing symptoms of stress, anxiety, or insomnia and meet threshold scores on one or more self-report inventories of these symptoms (Insomnia Severity Index (ISI, ≥ 8), the Perceived Stress Index (PSS, ≥ 14), or the Generalized Anxiety Disorder 7-item (GAD-7, ≥ 5) scale)
排除标准
- •participants providing less than 10 hours a week of care to a person
- •participants who are unable or unwilling to attend intervention sessions during the planned study period
- •participants who are unable or unwilling to provide consent
- •participants who are not exhibiting symptoms of stress, anxiety or insomnia
- •participants with hearing impairment severe enough that they cannot perceive tones through ear buds
- •participants with known seizure disorder, or suicidal thoughts within the last 3 months
- •participants who respond positively to a question about risk for suicide within the last 3 months will be excluded and receive a behavioral health resource list
- •participants weighing more than 400 pounds (the weight limit of the chair used during intervention)
- •participants currently enrolled in another intervention study
- •prior use (past 3 years) of the technology being tested
- •prior use of neuromodulation, neurostimulation, deep brain stimulation, neurofeedback, biofeedback, alpha stim, Eye Movement Desensitization and Reprocessing (EMDR),or electroconvulsive therapy within the last month
- •Pace makers and beta blockers that affect the assessment of heart rate variability will also be exclusionary
- •participants taking Medications that may affect the assessment of heart rate variability (beta blockers.
研究组 & 干预措施
Cereset Research
This will be the active intervention arm using 4 Cereset (CR) sessions and participants will continue current care.
干预措施: Cereset Research (Device)
Control
Participants will have 4 CR sessions of sham control tones and also continue their current care.
干预措施: Cereset Research (Device)
结局指标
主要结局
Change in Blood Pressure Measurements
时间窗: Baseline; V3 (4-7 weeks following completion of the intervention)
BP measurements will be obtained using an automate oscillometric blood pressure device. Three samples will be obtained and the last two averaged to get the value that will be used as the reading for that visit.
Change in Heart Rate (HR)
时间窗: Baseline; V3 (4-7 weeks following completion of the intervention)
Continuous heart rate will be recorded while participant is breathing normally in seated position for 10 minutes using Faros 180 heart rate monitor (Bittium Corporation, Oulu, Finland). Beat to beat intervals (RRI) files will be generated at 1000 Hz via the data acquisition software. Files will be analyzed with Nevrokard HRV software (by Nevrokard Kiauta, d.o.o., Izola, Slovenia). Recordings will be visually inspected to ensure data quality (dropped beats or gross motion artifacts are excluded) and first 5 minutes of usable tracings will be analyzed.
Change in Heart Rate Variability (HRV)
时间窗: Baseline; V3 (4-7 weeks following completion of the intervention)
Measures of heart rate variability in frequency domain will be derived and measures integrated over specified frequency ranges (LF: 0.04-0.15 Hz; HF: 0.15-0.4 Hz). Power of RRI spectra in LF, HF range (LFRRI and HFRRI) and total power (TP) will be calculated in normalized units and ratio of LF/HF used as a measure of sympatho-vagal balance.
Change in Baroreflex Sensitivity
时间窗: Baseline; V3 (4-7 weeks following completion of the intervention)
BRS calculated by this method is based on quantification of sequences of at least three beats (n) in which Systolic Blood Pressure (SBP) consecutively increases (UP sequence) or decreases (DOWN sequence), which are accompanied by changes in the same direction of the beat-to-beat intervals (RRI) of subsequent beats (n+1). The software scans the RRI and SBP records, identifies sequences, and calculates linear correlation between RRI and SBP for each sequence. The mean of all individual regression coefficients (slopes), a measure of sequence BRS, is calculated for Sequence UP, DOWN and ALL (ms/mmHg).
Blood Pressure Variability
时间窗: Baseline, V3 (4-7 weeks following completion of the intervention)
Systolic BP and beat to beat, RR intervals (RRI) files generated via the data acquisition system (BIOPAC acquisition system and software, Santa Barbara, CA) at 1000 Hz are analyzed using Nevrokard SA-BRS software (by Nevrokard Kiauta, d.o.o., Izola, Slovenia) for measures BPV.Frequency Method. Power spectral densities of SBP and RRI oscillations are computed by 512 points Fast Fourier Transform (FFT) and integrated over specified frequency ranges (LF: 0.04-0.15 Hz; HF: 0.15-0.4 Hz).
Change in Heart Rate (HR)
时间窗: Baseline; V3 (4-7 weeks following completion of the intervention)
Continuous heart rate will be recorded while participant is breathing normally in seated position for 10 minutes using Faros 180 heart rate monitor (Bittium Corporation, Oulu, Finland). Beat to beat intervals (RRI) files will be generated at 1000 Hz via the data acquisition software. Files will be analyzed with Nevrokard HRV software (by Nevrokard Kiauta, d.o.o., Izola, Slovenia). Recordings will be visually inspected to ensure data quality (dropped beats or gross motion artifacts are excluded) and first 5 minutes of usable tracings will be analyzed.
Change in Heart Rate Variability (HRV)
时间窗: Baseline; V3 (4-7 weeks following completion of the intervention)
Measures of heart rate variability in frequency domain will be derived and measures integrated over specified frequency ranges (LF: 0.04-0.15 Hz; HF: 0.15-0.4 Hz). Power of RRI spectra in LF, HF range (LFRRI and HFRRI) and total power (TP) will be calculated in normalized units and ratio of LF/HF used as a measure of sympatho-vagal balance.
Change in Baroreflex Sensitivity
时间窗: Baseline; V3 (4-7 weeks following completion of the intervention)
BRS calculated by this method is based on quantification of sequences of at least three beats (n) in which Systolic Blood Pressure (SBP) consecutively increases (UP sequence) or decreases (DOWN sequence), which are accompanied by changes in the same direction of the beat-to-beat intervals (RRI) of subsequent beats (n+1). The software scans the RRI and SBP records, identifies sequences, and calculates linear correlation between RRI and SBP for each sequence. The mean of all individual regression coefficients (slopes), a measure of sequence BRS, is calculated for Sequence UP, DOWN and ALL (ms/mmHg).
Blood Pressure Variability
时间窗: Baseline, V3 (4-7 weeks following completion of the intervention)
Systolic BP and beat to beat, RR intervals (RRI) files generated via the data acquisition system (BIOPAC acquisition system and software, Santa Barbara, CA) at 1000 Hz are analyzed using Nevrokard SA-BRS software (by Nevrokard Kiauta, d.o.o., Izola, Slovenia) for measures BPV.Frequency Method. Power spectral densities of SBP and RRI oscillations are computed by 512 points Fast Fourier Transform (FFT) and integrated over specified frequency ranges (LF: 0.04-0.15 Hz; HF: 0.15-0.4 Hz).
次要结局
- Center for Epidemiologic Studies Depression Scale (CES-D)(Baseline, V2 (0-14 days after intervention completion, and V3 (4-7 weeks following completion of the intervention))
- Perceived Stress Scale (PSS)(Baseline, V2 (0-14 days after intervention completion, and V3 (4-7 weeks following completion of the intervention))
- Quality of Life Scale (QOLS)(Baseline, V2 (0-14 days after intervention completion, and V3 (4-7 weeks following completion of the intervention))
- Severity of Insomnia (ISI)(Baseline, V2 (0-14 days after intervention completion, and V3 (4-7 weeks following completion of the intervention))
- Caregiver Burden (Zarit)(Baseline, V2 (0-14 days after intervention completion, and V3 (4-7 weeks following completion of the intervention))
- Generalized Anxiety Disorder-7 (GAD-7) scores(Baseline, V2 (0-14 days after intervention completion, and V3 (4-7 weeks following completion of the intervention))
- Caregiver Distress (NPI-Q)(Baseline, V2 (0-14 days after intervention completion, and V3 (4-7 weeks following completion of the intervention))
- PTSD Checklist for civilians (PCL-C)(Baseline, V2 (0-14 days after intervention completion, and V3 (4-7 weeks following completion of the intervention))