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HIRREM for Stage 1 Primary Hypertension (HIRREM)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03479697
Recruitment Status : Recruiting
First Posted : March 27, 2018
Last Update Posted : August 8, 2019
Sponsor:
Information provided by (Responsible Party):
Wake Forest University Health Sciences

Brief Summary:
The purpose of this study is to determine that effects of an intervention called High-resolution, relational, resonance-based, electroencephalic mirroring (HIRREM), on Stage 1 Primary Hypertension (systolic BP 130-139, and/or diastolic BP 80-89).

Condition or disease Intervention/treatment Phase
Hypertension Blood Pressure Cardiovascular Diseases Cardiovascular Risk Factor Autonomic Nervous System Imbalance Device: HIRREM Other: Continued Current Care Not Applicable

Detailed Description:

The purpose of this research study is to determine the effects of a technique called High-resolution, relational, resonance-based, electroencephalic mirroring (HIRREM®), for hypertension. HIRREM uses scalp sensors to monitor brain electrical activity, and computer software algorithms translate selected brain frequencies into audible tones in real time. Those tones are reflected back to participants via ear buds in as little as four to eight milliseconds, providing the brain an opportunity for self-adjustment of its electrical pattern.

This study will compare acoustic stimulation linked to brainwave activity (HIRREM, along with continued current care, HCC), with continued current clinical care alone (CCC). Both groups will continue their other current care throughout, including non-pharmacological, and lifestyle modification therapies.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 24 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Intervention Model Description: This study will compare acoustic stimulation linked to brainwave activity (HIRREM, along with continued current care, HCC), with continued current clinical care alone (CCC). Both groups will continue their other current care throughout, including non-pharmacological, and lifestyle modification therapies. The participants in the CCC group will be offered the opportunity to crossover and receive a course of HCC.
Masking: None (Open Label)
Primary Purpose: Supportive Care
Official Title: High-Resolution, Relational, Resonance-Based, Electroencephalic Mirroring (HIRREM) for Stage 1 Primary Hypertension
Actual Study Start Date : August 8, 2018
Estimated Primary Completion Date : July 2020
Estimated Study Completion Date : July 2021

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: HIRREM
High-resolution, relational, resonance-based, electroencephalic mirroring (HIRREM) is a novel, noninvasive, closed-loop, brainwave mirroring, acoustic stimulation neurotechnology to support relaxation and auto-calibration of neural oscillations, using auditory tones to reflect brain frequencies in near real time.
Device: HIRREM
Technology
Other Names:
  • High-resolution, relational, resonance-based, electroencephalic mirroring
  • Brainwave Optimization

Other: Continued Current Care
Continue their current clinical care.

Continued Current Care
Participants will continue their current care.
Device: HIRREM
Technology
Other Names:
  • High-resolution, relational, resonance-based, electroencephalic mirroring
  • Brainwave Optimization

Other: Continued Current Care
Continue their current clinical care.




Primary Outcome Measures :
  1. Change from baseline in blood pressure, as measured by an automated oscillometric blood pressure device. [ Time Frame: Baseline, 1-14 days post final session, 4-6 weeks post final session, 12-14 weeks post final session ]
    BP will be obtained in the left arm, with the participant sitting comfortably, and the left arm resting on a desk/table. Three samples will be obtained and the last two averaged to get the value that will be used as the reading.


Secondary Outcome Measures :
  1. Change in Heart Rate Variability [ Time Frame: Baseline, 1-14 days post final session, 4-6 weeks post final session, 12-14 weeks post final session ]
    Blood pressure and heart rate are acquired from 10 minute recordings of noninvasive finger arterial pressure measurements and ECG with participants lying quietly, supine. Systolic BP and beat to beat, RR intervals files generated via the data acquisition system (BIOPAC acquisition system and Acknowledge 4.2 software, Santa Barbara, CA), at 1000 Hz, are analyzed using Nevrokard BRS software (Nevrokard BRS, Medistar, Ljubljana, Slovenia). Analysis is conducted on the first complete 5-minute epoch that is considered to be acceptable for analysis. Heart rate variability is measured in the time domain as standard deviation of beat-to-beat interval (SDNN, milliseconds). For calculation of SDNN, the R-R intervals are visually inspected, and data considered as artifact is manually removed.

  2. Change in Baroreflex Sensitivity [ Time Frame: Baseline, 1-14 days post final session, 4-6 weeks post final session, 12-14 weeks post final session ]
    Blood pressure and heart rate are acquired from 10 minute recordings of noninvasive finger arterial pressure measurements and ECG with participants lying quietly, supine. Systolic BP and beat to beat, RR intervals files generated via the data acquisition system (BIOPAC acquisition system and Acknowledge 4.2 software, Santa Barbara, CA), at 1000 Hz, are analyzed using Nevrokard BRS software (Nevrokard BRS, Medistar, Ljubljana, Slovenia). Analysis is conducted on the first complete 5-minute epoch that is considered to be acceptable for analysis. Heart rate variability is measured in the time domain as standard deviation of beat-to-beat interval (SDNN, milliseconds). For calculation of SDNN, the R-R intervals are visually inspected, and data considered as artifact is manually removed.

  3. Change in Insomnia Severity Index (ISI) [ Time Frame: Baseline, 1-14 days post final session, 4-6 weeks post final session, 12-14 weeks post final session ]
    The severity of insomnia symptoms is measured using the ISI with each data collection visit. The ISI is a 7 question measure, with responses from 0-4 for each question, yielding scores ranging from 0-28. Higher scores indicate the strength of the insomnia severity.

  4. Change in Pittsburgh Sleep Quality Index (PSQI) [ Time Frame: Baseline, 1-14 days post final session, 4-6 weeks post final session, 12-14 weeks post final session ]
    The PSQI is a 19 item inventory that assesses sleep quality over a 1-month time interval. Items are weighted on a 0-3 interval scale. A global PSQI score is calculated by totaling the seven component scores, providing an overall score ranging from 0 to 21, where lower scores denote a healthier sleep quality.

  5. Change in Epworth Sleepiness Score (ESS) [ Time Frame: Baseline, 1-14 days post final session, 4-6 weeks post final session, 12-14 weeks post final session ]
    The ESS measures a person's general level of daytime sleepiness, or their average sleep propensity in daily life. The simple questionnaire is based on retrospective reports of the likelihood of dozing off or falling asleep in a variety of different situations. Rated on a 4-point scale (0-3), it evaluates their usual chances of dozing off or falling asleep while engaged in eight different activities. The ESS score (the sum of 8 item scores, 0-3) can range from 0 to 24. Lower scores denote a lower level of daytime sleepiness.

  6. Change in Center for Epidemiologic Studies Depression Scale (CES-D) [ Time Frame: Baseline, 1-14 days post final session, 4-6 weeks post final session, 12-14 weeks post final session ]
    The 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. Higher scores indicate the presence of more symptomatology.

  7. Change in Generalized Anxiety Disorder-7 (GAD-7) [ Time Frame: Baseline, 1-14 days post final session, 4-6 weeks post final session, 12-14 weeks post final session ]
    The GAD-7 is a seven item screening tool for anxiety that is widely used in primary care. Scores range from 0-21. A lower score denotes a lower level of anxiety.

  8. Change in PTSD Checklist for Civilians (PCL-C) [ Time Frame: Baseline, 1-14 days post final session, 4-6 weeks post final session, 12-14 weeks post final session ]
    The 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 related to civilians. 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.

  9. Change in Perceived Stress Scale (PSS) [ Time Frame: Baseline, 1-14 days post final session, 4-6 weeks post final session, 12-14 weeks post final session ]
    The PSS is a ten-item psychological instrument for measuring the perception of stress. It is a measure of the degree to which situations in one's life are appraised as stressful. Scores range from 0-40. A lower score denotes a lower level of perceived stress.

  10. Change in International Physical Activity Questionnaire (IPAQ-SF) [ Time Frame: Baseline, 1-14 days post final session, 4-6 weeks post final session, 12-14 weeks post final session ]
    This is a four item questionnaire asking about physical activity in the last 7 days. Scores are calculated and categorized as low, moderate, or high. A higher score denotes more physical activity.

  11. Change in HIRREM Physical Activity Satisfaction Questions [ Time Frame: Baseline, 1-14 days post final session, 4-6 weeks post final session, 12-14 weeks post final session ]
    This is a four item questionnaire asking about the participants level of satisfaction with their physical activity. Responses range from 0-6 for each question, yielding scores ranging from 0-24. Higher scores denote a higher level of satisfaction.

  12. Change in Quality of Life Scale (QOLS) [ Time Frame: Baseline, 1-14 days post final session, 4-6 weeks post final session, 12-14 weeks post final session ]
    The QOLS ) is a 16-item scale that was modified from a 15-item scale used in chronic disease patients. Topics include different components of daily life such as relationships, community engagement, personal fulfillment, and recreation. Each item is scaled from 1 to 7 and a sum score is calculated to represent higher levels of satisfaction in life (range is 16-112).

  13. Change in Drop Stick Reaction Time [ Time Frame: Baseline, 1-14 days post final session, 4-6 weeks post final session, 12-14 weeks post final session ]
    Reaction testing will be evaluated by a drop-stick, clinical reaction time apparatus. The apparatus is placed between the thumb and index finger of the subject and released at a random time during a countdown. The subject catches the apparatus and the distance fallen (cm) is converted to reaction. Following two practice trials, participants perform eight trials, and a mean distance value is calculated. This is repeated with a second set of 8 trials later during the enrollment visit, and the mean distance value from the second trial will be used as the baseline value. Use of the average distance from the second set of trials will be used as the baseline value so as to avoid the impact of learning effect for this test. Only one set of trials will be used for comparison at follow up data collections. A lower average indicates a faster reaction time.

  14. Change in Grip Strength [ Time Frame: Baseline, 1-14 days post final session, 4-6 weeks post final session, 12-14 weeks post final session ]
    Grip strength will be evaluated using a hydraulic hand dynamometer (Baseline Hydraulic Hand Dynamometer). Participants will squeeze the dynamometer three times in each hand. The scores from each hand will be averaged separately. A higher score indicates stronger grip strength.


Other Outcome Measures:
  1. Change in Alcohol Intake Screening (Audit-C) [ Time Frame: Baseline, 1-14 days post final session, 4-6 weeks post final session, 12-14 weeks post final session ]
    The AUDIT-C is a short, 3-item alcohol screening for hazardous drinkers or active alcohol use disorders. This measure consists of 3 questions to assess an individual's alcohol use. Each question has five possible answers ranging from of 0-4 with a total scoring scale of 0-12. A total score of three or more in women and a score of four or more in men is suggestive of hazardous drinking or active alcohol use disorders.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Adults, age 18 and above
  • Systolic BP ranging from 130-139mmHg and/or diastolic BP ranging from 80-89mmHg

Exclusion Criteria:

  • Unable, unwilling, or incompetent to provide informed consent
  • Physically unable to come to the study visits, or to sit comfortably in a chair for up to two hours at a time
  • Weight is over the chair limit (285 pounds)
  • Known atherosclerotic cardiovascular disease
  • Cardiovascular risk score of ≥ 10% (per http://tools.acc.org/ASCVD-Risk-Estimator-Plus/#!/calculate/estimate/)
  • Prior diagnosis of stage 2 hypertension
  • Ongoing need for treatment of hypertension with medications
  • Known seizure disorder
  • Known or anticipated pregnancy
  • Severe hearing impairment (because the subject will be using headphones during the interventions)
  • Ongoing need for treatment with opiate, benzodiazepine, or anti-psychotic medications, anti-depressant medications such as SSRI, SNRI, or tricyclic, and sleep medications such as zolpidem or eszopiclone
  • Anticipated and ongoing use of recreational drugs, alcohol, or energy drinks
  • Ongoing need for treatment with thyroid medications
  • Are enrolled in another research study that includes an active intervention
  • Have previously received brainwave optimization (BWO), used a B2 or B2v2 wearable device, or previously participated in a HIRREM research study

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03479697


Contacts
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Contact: Study Coordinator 336-716-9447 wfhirrem@wakehealth.edu

Locations
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United States, North Carolina
Department of Neurology, Wake Forest School of Medicine Recruiting
Winston-Salem, North Carolina, United States, 27157
Contact: Study Coordinator    336-716-9447    WFHIRREM@wakehealth.edu   
Principal Investigator: Charles Tegeler, MD         
Sponsors and Collaborators
Wake Forest University Health Sciences
Investigators
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Principal Investigator: Charles Tegeler, MD Wake Forest University Health Sciences
  Study Documents (Full-Text)

Documents provided by Wake Forest University Health Sciences:

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Responsible Party: Wake Forest University Health Sciences
ClinicalTrials.gov Identifier: NCT03479697    
Other Study ID Numbers: IRB00047477
First Posted: March 27, 2018    Key Record Dates
Last Update Posted: August 8, 2019
Last Verified: August 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Device Product Not Approved or Cleared by U.S. FDA: Yes
Keywords provided by Wake Forest University Health Sciences:
HIRREM
Neurotechnology
Closed-Loop
Allostasis
Stress
Autonomic Dysregulation
Hyperarousal
Brain Electrical Activity
Acoustic Stimulation
Primary Hypertension
High Blood Pressure
Additional relevant MeSH terms:
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Hypertension
Essential Hypertension
Cardiovascular Diseases
Vascular Diseases