HypertensionHIRREMNCT03479697
HIRREM for Stage 1 Primary Hypertension
A study testing HIRREM and Continued Current Care in people with Hypertension and Blood Pressure, run by Wake Forest University Health Sciences at 1 site in United States.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hypertension, Blood Pressure, Cardiovascular Diseases
- What is being tested?
- HIRREM and Continued Current Care
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 5 participants
- Where
- 1 siteUnited States
- Study dates
- 8 Aug 2018to 13 Nov 2020
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adults, age 18 and above
- Systolic BP ranging from 130-139mmHg and/or diastolic BP ranging from 80-89mmHg
Who cannot join
- 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
Show all 15Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Department of Neurology, Wake Forest School of Medicine
Winston-Salem, North Carolina, 27157
About this study
Official title: High-Resolution, Relational, Resonance-Based, Electroencephalic Mirroring (HIRREM) for Stage 1 Primary Hypertension
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).
Read the 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.
- Conditions
- Hypertension, Blood Pressure, Cardiovascular Diseases, Cardiovascular Risk Factor, Autonomic Nervous System Imbalance
- Being tested
- HIRREM, Continued Current Care
- Keywords
- HIRREM, Neurotechnology, Closed-Loop, Allostasis, Stress, Autonomic Dysregulation, Hyperarousal, Brain Electrical Activity, Acoustic Stimulation, Primary Hypertension, High Blood Pressure
- Medical subject headings
- Hypertension, Cardiovascular Diseases, Primary Dysautonomias, Essential Hypertension
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HIRREMDevice
Also called High-resolution, relational, resonance-based, electroencephalic mirroring, Brainwave Optimization
Technology
Continued Current CareOther
Continue their current clinical care.
| Study group | Role | What they receive |
|---|---|---|
| HIRREM | Active comparator | 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. Receives: Device: HIRREM; Other: Continued Current Care |
| Continued Current Care | Other | Participants will continue their current care. Receives: Device: HIRREM; Other: Continued Current Care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change From Baseline in Blood Pressure, as Measured by an Automated Oscillometric Blood Pressure Device.
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. Primary outcome will be at V3 (4-6 weeks post final session).
Measured: Baseline to V3 (4-6 weeks following completion of the intervention for HCC, 8-10 weeks after V1 for CCC).
Secondary outcomes (14)
Change in Heart Rate Variability (SDNN)
Heart rate variability is measured in the time domain as standard deviation of beat-to-beat interval
Measured: Baseline to V3 (4-6 weeks following completion of the intervention for HCC, 8-10 weeks after V1 for CCC).
Change in Baroreflex Sensitivity
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 at 1000 Hz, are analyzed using Nevrokard BRS software. Analysis is conducted on the first complete 5-minute epoch. Power spectral densities of systolic blood pressure (SBP) and R-R interval (RRI) oscillations are computed by 512 points Fast Fourier Transform (FFT) and integrated over specified frequency ranges (HF: 0.15-0.4 Hz). The square-root of the ratio of RRI's and SBP powers is computed to calculate HF alpha indices, which reflect BRS. The software scans the RRI and SBP records, identifies sequences, and calculates linear correlation between RRI and SBP for each sequence. A measure of sequence BRS is then calculated as Sequence ALL.
Measured: Baseline to V3 (4-6 weeks following completion of the intervention for HCC, 8-10 weeks after V1 for CCC).
Change in Insomnia Severity Index (ISI)
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.
Measured: Baseline to V3 (4-6 weeks following completion of the intervention for HCC, 8-10 weeks after V1 for CCC).
Change in Pittsburgh Sleep Quality Index (PSQI)
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.
Measured: Baseline to V3 (4-6 weeks following completion of the intervention for HCC, 8-10 weeks after V1 for CCC).
Change in Epworth Sleepiness Score (ESS)
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.
Measured: Baseline to V3 (4-6 weeks following completion of the intervention for HCC, 8-10 weeks after V1 for CCC).
Change in Center for Epidemiologic Studies Depression Scale (CES-D)
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.
Measured: Baseline to V3 (4-6 weeks following completion of the intervention for HCC, 8-10 weeks after V1 for CCC).
Change in Generalized Anxiety Disorder-7 (GAD-7)
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.
Measured: Baseline to V3 (4-6 weeks following completion of the intervention for HCC, 8-10 weeks after V1 for CCC).
Change in PTSD Checklist for Civilians (PCL-C)
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.
Measured: Baseline to V3 (4-6 weeks following completion of the intervention for HCC, 8-10 weeks after V1 for CCC).
Change in Perceived Stress Scale (PSS)
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.
Measured: Baseline to V3 (4-6 weeks following completion of the intervention for HCC, 8-10 weeks after V1 for CCC).
Change in International Physical Activity Questionnaire (IPAQ-SF)
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. For results, categories could not be presented so they were coded as: 1=low, 2=moderate, and 3=high.
Measured: Baseline to V3 (4-6 weeks following completion of the intervention for HCC, 8-10 weeks after V1 for CCC).
Change in HIRREM Physical Activity Satisfaction Questions
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.
Measured: Baseline to V3 (4-6 weeks following completion of the intervention for HCC, 8-10 weeks after V1 for CCC).
Change in Quality of Life Scale (QOLS)
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).
Measured: Baseline to V3 (4-6 weeks following completion of the intervention for HCC, 8-10 weeks after V1 for CCC).
Change in Drop Stick Reaction Time
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.
Measured: Baseline to V3 (4-6 weeks following completion of the intervention for HCC, 8-10 weeks after V1 for CCC).
Change in Grip Strength
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.
Measured: Baseline to V3 (4-6 weeks following completion of the intervention for HCC, 8-10 weeks after V1 for CCC).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Mar 2018
- Study start8 Aug 2018
- Primary completion13 Nov 2020
- Study completion13 Nov 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for HypertensionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Crossover
- 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)
- Enrolment
- 5 participants (actual)
Sponsor and investigators
- Lead sponsor
- Wake Forest University Health Sciences
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Charles Tegeler, MD, Principal investigator, Wake Forest University Health Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03479697
- Sponsor's protocol ID
- IRB00047477
- Acronym
- HIRREM
- Status last verified
- Jul 2022
- First submitted
- 20 Mar 2018
- Last updated
- 20 Apr 2023
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 20 Apr 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- High-Resolution, Relational, Resonance-Based, Electroencephalic Mirroring (HIRREM) for Stage 1 Primary Hypertension
- ClinicalTrials.gov ID
- NCT03479697
- Acronym / sponsor ID
- HIRREM / IRB00047477
- Conditions
- Hypertension, Blood Pressure, Cardiovascular Diseases, Cardiovascular Risk Factor, Autonomic Nervous System Imbalance
- Keywords
- HIRREM, Neurotechnology, Closed-Loop, Allostasis, Stress, Autonomic Dysregulation, Hyperarousal, Brain Electrical Activity
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 5 participants (actual)
- Lead sponsor
- Wake Forest University Health SciencesUniversity, hospital or other
- Study start
- 8 Aug 2018 (actual)
- Primary completion
- 13 Nov 2020 (actual)
- Study completion
- 13 Nov 2020 (actual)
- First posted
- 27 Mar 2018 (actual)
- Results
- Posted 20 Apr 2023
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
- 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.
| Arm | Type | Receives |
|---|---|---|
| HIRREM | Active comparator | Device: HIRREM, Other: Continued Current CareHigh-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. |
| Continued Current Care | Other | Device: HIRREM, Other: Continued Current CareParticipants will continue their current care. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Adults, age 18 and above
- Systolic BP ranging from 130-139mmHg and/or diastolic BP ranging from 80-89mmHg
Key exclusion criteria (15 listed)
- 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/)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| HIRREMAlso: High-resolution, relational, resonance-based, electroencephalic mirroring, Brainwave OptimizationTechnology | Device | Continued Current Care, HIRREM |
| Continued Current CareContinue their current clinical care. | Other | Continued Current Care, HIRREM |
Primary outcome
Change From Baseline in Blood Pressure, as Measured by an Automated Oscillometric Blood Pressure Device.
Time frame: Baseline to V3 (4-6 weeks following completion of the intervention for HCC, 8-10 weeks after V1 for CCC).
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. Primary outcome will be at V3 (4-6 weeks post final session).
14 secondary outcomes
Change in Heart Rate Variability (SDNN)
Time frame: Baseline to V3 (4-6 weeks following completion of the intervention for HCC, 8-10 weeks after V1 for CCC).
Change in Baroreflex Sensitivity
Time frame: Baseline to V3 (4-6 weeks following completion of the intervention for HCC, 8-10 weeks after V1 for CCC).
Change in Insomnia Severity Index (ISI)
Time frame: Baseline to V3 (4-6 weeks following completion of the intervention for HCC, 8-10 weeks after V1 for CCC).
Change in Pittsburgh Sleep Quality Index (PSQI)
Time frame: Baseline to V3 (4-6 weeks following completion of the intervention for HCC, 8-10 weeks after V1 for CCC).
Change in Epworth Sleepiness Score (ESS)
Time frame: Baseline to V3 (4-6 weeks following completion of the intervention for HCC, 8-10 weeks after V1 for CCC).
Change in Center for Epidemiologic Studies Depression Scale (CES-D)
Time frame: Baseline to V3 (4-6 weeks following completion of the intervention for HCC, 8-10 weeks after V1 for CCC).
Change in Generalized Anxiety Disorder-7 (GAD-7)
Time frame: Baseline to V3 (4-6 weeks following completion of the intervention for HCC, 8-10 weeks after V1 for CCC).
Change in PTSD Checklist for Civilians (PCL-C)
Time frame: Baseline to V3 (4-6 weeks following completion of the intervention for HCC, 8-10 weeks after V1 for CCC).
Change in Perceived Stress Scale (PSS)
Time frame: Baseline to V3 (4-6 weeks following completion of the intervention for HCC, 8-10 weeks after V1 for CCC).
Change in International Physical Activity Questionnaire (IPAQ-SF)
Time frame: Baseline to V3 (4-6 weeks following completion of the intervention for HCC, 8-10 weeks after V1 for CCC).
Change in HIRREM Physical Activity Satisfaction Questions
Time frame: Baseline to V3 (4-6 weeks following completion of the intervention for HCC, 8-10 weeks after V1 for CCC).
Change in Quality of Life Scale (QOLS)
Time frame: Baseline to V3 (4-6 weeks following completion of the intervention for HCC, 8-10 weeks after V1 for CCC).
Change in Drop Stick Reaction Time
Time frame: Baseline to V3 (4-6 weeks following completion of the intervention for HCC, 8-10 weeks after V1 for CCC).
Change in Grip Strength
Time frame: Baseline to V3 (4-6 weeks following completion of the intervention for HCC, 8-10 weeks after V1 for CCC).
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Apr 2023.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Charles Tegeler, MD principal investigator
Wake Forest University Health Sciences
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing HIRREM and Continued Current Care in people with Hypertension and Blood Pressure, run by Wake Forest University Health Sciences at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 20 Apr 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 20 Apr 2023). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change From Baseline in Blood Pressure, as Measured by an Automated Oscillometric Blood Pressure Device. (time frame: Baseline to V3 (4-6 weeks following completion of the intervention for HCC, 8-10 weeks after V1 for CCC).). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Apr 2023.