Cereset Research for Caregivers
ConditionCaregivers
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorWake Forest University Health Sciences
About this trial
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.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
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
Disqualifiers
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
Trial design
Design model
Single group
Treatments tested in this trial
Cereset Research
DeviceCereset 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 closed. Four sensors are applied to the scalp at a time. However, only two sensors are actively echoing feedback. The software automatically switches from one sensor pair to the other when needed. This reduces the number of sensor placement changes needed, resulting in shorter session time and fewer interruptions.
Treatment groups
20 Participants
are divided into 2 treatment groupsGroup A: Cereset ResearchActive comparator 1 intervention
Group B: ControlSham comparator 1 intervention
Trial outcomes
Primary outcomes
1
Change in Blood Pressure Measurements
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.
Time frame
Baseline; V3 (4-7 weeks following completion of the intervention)2
Change in Heart Rate (HR)
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.
Time frame
Baseline; V3 (4-7 weeks following completion of the intervention)3
Change in Heart Rate Variability (HRV)
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.
Time frame
Baseline; V3 (4-7 weeks following completion of the intervention)4
Change in Baroreflex Sensitivity
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).
Time frame
Baseline; V3 (4-7 weeks following completion of the intervention)Secondary outcomes
1
Severity of Insomnia (ISI)
The ISI is a 7 question, self-reported measure to evaluate symptoms of insomnia, with responses from 0-4 for each question, yielding scores ranging from 0-28. Lower scores represent better outcomes.
Time frame
Baseline, V2 (0-14 days after intervention completion, and V3 (4-7 weeks following completion of the intervention)2
Center for Epidemiologic Studies Depression Scale (CES-D)
The Center for Epidemiologic Studies Depression Scale (CES-D) is a depression scale, which will help to assess this co-morbidity. CES-D is a 20-item survey assessing affective depressive symptomatology to screen for risk of depression. Scores range from 0-60, with a score of 16 commonly used as a clinically relevant cut-off. The higher the score, the more suggestive of depressive symptoms.
Time frame
Baseline, V2 (0-14 days after intervention completion, and V3 (4-7 weeks following completion of the intervention)3
Generalized Anxiety Disorder-7 (GAD-7) scores
The Generalized Anxiety Disorder-7 (GAD-7) is a seven-item screening tool for anxiety that is widely used in primary care. GAD-7 is a brief, reliable and valid measure of assessing generalized anxiety disorder. A score of 10 or greater on the GAD-7 represents a reasonable cut point for identifying cases. Cut points of 5, 10, and 15 might be interpreted as representing mild, moderate, and severe levels of anxiety.
Time frame
Baseline, V2 (0-14 days after intervention completion, and V3 (4-7 weeks following completion of the intervention)4
PTSD Checklist for civilians (PCL-C)
The PTSD Checklist for civilians (PCL-C), measures the American Psychiatric Association's Diagnostic and statistical manual of mental disorders (DSM-IV) Criteria B, C, \& D of PTSD symptoms based on traumatic life experience either in civilian life. Seventeen items are rated on a Likert scale with a composite score range of 17 to 85. A score of 44 or higher correlates with probability of civilian-related PTSD. Higher scores suggest more traumatic stress.
Time frame
Baseline, V2 (0-14 days after intervention completion, and V3 (4-7 weeks following completion of the intervention)Other outcomes
1
Changes in Chronic Pain (MPQ)
For participants reporting chronic pain, the Short Form McGill Pain Questionnaire (MPQ) questionnaire will be given. The maximum score an individual can reach on the MPQ is 78. According to the questionnaire, a person with a score of 0 effectively does not experience pain. A person with a high score, nearer to the highest score of 78, more than likely deals with chronic pain daily.
Time frame
Baseline, V2 (0-14 days after intervention completion, and V3 (4-7 weeks following completion of the intervention)2
Changes in Chronic Pain (PROMIS)
For participants reporting chronic pain, the Patient-Reported Outcomes Measurement Information System (PROMIS) Short Form Pain Interference questionnaire will be given. scales focus on how frequently patients engage in each pain behavior using a 6-point Likert-type scale, ranging from 1 (had no pain) to 6 (always), with responses reflecting the 7-day recall period.
Time frame
Baseline, V2 (0-14 days after intervention completion, and V3 (4-7 weeks following completion of the intervention)Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Wake Forest University Health Sciences
Lead sponsor
Memory Counseling Program general fund
Collaborator
Heidi Munger-Clary, MD
Collaborator
Hossam Shaltout, PhD
Collaborator
Sean Simpson, PhD
Collaborator
Christina Hugenschmidt, PhD
Collaborator
Mia Yang, MD
Collaborator
Source ClinicalTrials.gov