Cereset Research for Caregivers

Официальное название

Cereset Research for Caregivers: A Randomized, Controlled Trial

Обзор

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.

Подробное описание

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.

1. Insomnia as assessed by the Insomnia Severity Index (ISI). 2. 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). 3. Overall quality of life as evaluated using the QOLS measure. 4. Caregiver burden and distress measured with the Zarit Caregiver Burden scale and the Neuropsychiatric Inventory Questionnaire (NPI-Q). 5. Brief (4-item) caregiver self-efficacy scale.

Вмешательства

• Устройство Cereset Research
  Cereset Research The upgraded platform for medical research using the HIRREM technology has been rebranded as Cereset Research® (CR). This system uses the same core technology and algorithms to echo brainwaves in real-time using audible tones, as with HIRREM. The CR system also includes 64-bit processing architecture for faster feedback, the use of 4 sensors, and the use of standard protocols (with flexibility regarding the length and sequencing of the standard protocols), all done with eyes clo

Первичные конечные точки

• Change in Blood Pressure Measurements [Срок оценки: Baseline; V3 (4-7 weeks following completion of the intervention)]
• Change in Heart Rate (HR) [Срок оценки: Baseline; V3 (4-7 weeks following completion of the intervention)]
• Change in Heart Rate Variability (HRV) [Срок оценки: Baseline; V3 (4-7 weeks following completion of the intervention)]
• Change in Baroreflex Sensitivity [Срок оценки: Baseline; V3 (4-7 weeks following completion of the intervention)]
• Blood Pressure Variability [Срок оценки: Baseline, V3 (4-7 weeks following completion of the intervention)]

Вторичные конечные точки (8)

• Severity of Insomnia (ISI) [Срок оценки: Baseline, V2 (0-14 days after intervention completion, and V3 (4-7 weeks following completion of the intervention)]
• Center for Epidemiologic Studies Depression Scale (CES-D) [Срок оценки: 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 [Срок оценки: Baseline, V2 (0-14 days after intervention completion, and V3 (4-7 weeks following completion of the intervention)]
• PTSD Checklist for civilians (PCL-C) [Срок оценки: Baseline, V2 (0-14 days after intervention completion, and V3 (4-7 weeks following completion of the intervention)]
• Perceived Stress Scale (PSS) [Срок оценки: Baseline, V2 (0-14 days after intervention completion, and V3 (4-7 weeks following completion of the intervention)]
• Quality of Life Scale (QOLS) [Срок оценки: Baseline, V2 (0-14 days after intervention completion, and V3 (4-7 weeks following completion of the intervention)]
• Caregiver Burden (Zarit) [Срок оценки: Baseline, V2 (0-14 days after intervention completion, and V3 (4-7 weeks following completion of the intervention)]
• Caregiver Distress (NPI-Q) [Срок оценки: Baseline, V2 (0-14 days after intervention completion, and V3 (4-7 weeks following completion of the intervention)]

Критерии участия

Критерии включения

• 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)

Критерии исключения

• 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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Да

Дизайн исследования

Распределение

Рандомизированное

Модель

Одна группа

Маскирование

Простое слепое

Основная цель

Поддерживающая терапия

Центры проведения

США · 1 центр

• Wake Forest University Health Sciences — Winston-Salem

Публикации

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Идентификаторы

NCT: NCT05209438 · IRB00078620

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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