Cereset Research for Caregivers: A Randomized, Controlled Trial
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Not specified
- Sponsor
- Wake Forest University Health Sciences
- Enrollment
- 20
- Locations
- 1
- Primary Endpoint
- Change in Blood Pressure Measurements
- Status
- Recruiting
- Last Updated
- 9 months ago
Overview
Brief Summary
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.
Detailed Description
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.
Investigators
Eligibility Criteria
Inclusion Criteria
- •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)
- •Exclusion criteria:
- •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
Exclusion Criteria
- Not provided
Outcomes
Primary Outcomes
Change in Blood Pressure Measurements
Time Frame: 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)
Time Frame: 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)
Time Frame: 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
Time Frame: 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
Time Frame: 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).
Secondary Outcomes
- 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))