Study Results
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Basic Information
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RECRUITING
NA
20 participants
INTERVENTIONAL
2022-06-16
2026-07-31
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
SINGLE_GROUP
Phase II will be a single-blind, randomized, pilot clinical trial that aims to enroll 20 participants who will be randomized to receive 4 sessions of CR intervention linked to brainwaves (INT) (n=10) or 4 sessions of sham control tones not linked to brainwaves (CON) (n=10). In this study, the tones not linked to brainwaves will be used as the control.
SUPPORTIVE_CARE
SINGLE
Phase 2 - Participants will not be told which group they are assigned to until the end of the study.
Study Groups
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Cereset Research
This will be the active intervention arm using 4 Cereset (CR) sessions and participants will continue current care.
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 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.
Control
Participants will have 4 CR sessions of sham control tones and also continue their current care.
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 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.
Interventions
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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 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.
Eligibility Criteria
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Inclusion Criteria
* 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 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.
18 Years
ALL
Yes
Sponsors
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Memory Counseling Program general fund
UNKNOWN
Heidi Munger-Clary, MD
UNKNOWN
Hossam Shaltout, PhD
UNKNOWN
Sean Simpson, PhD
UNKNOWN
Christina Hugenschmidt, PhD
UNKNOWN
Mia Yang, MD
UNKNOWN
Wake Forest University Health Sciences
OTHER
Responsible Party
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Principal Investigators
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Charles Tegeler, MD
Role: PRINCIPAL_INVESTIGATOR
Wake Forest University Health Sciences
Locations
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Wake Forest University Health Sciences
Winston-Salem, North Carolina, United States
Countries
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Central Contacts
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Facility Contacts
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References
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Other Identifiers
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IRB00078620
Identifier Type: -
Identifier Source: org_study_id
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