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Clinical Trial Summary

Caregivers of a person living with dementia (PLWD) 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 of a person living with dementia. 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.

Clinical Trial Description

Phase I: Intervention only pre-piloting: up to 5 adults; mirroring Phase II characteristics described below Phase II: 20 dementia 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. ;

Study Design

Related Conditions & MeSH terms

NCT number NCT05209438
Study type Interventional
Source Wake Forest University Health Sciences
Contact Dawn Higgins
Phone 336-716-9447
Status Recruiting
Phase N/A
Start date June 16, 2022
Completion date July 2025

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