Clinical trial NCT03332043: HIRREM for Pre-Hypertension
Official title: High-resolution, Relational, Resonance-based, Electroencephalic Mirroring (HIRREM) for Pre-Hypertension: A Randomized, Controlled Clinical Trial
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Prehypertension
Blood Pressure
Autonomic Nervous System Imbalance
Cardiovascular Risk Factor
Cardiovascular Diseases
Brain Diseases
Keywords: HIRREM
Neurotechnology
Closed-loop
Acoustic stimulation
Allostatic
Heart rate variability
Baroreflex sensitivity
Blood pressure management
Autocalibration
Neural oscillations
Relaxation
Electroencephalic
Lead sponsor: Wake Forest University Health Sciences
Sponsor class: OTHER
First posted: 2017-11-06
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This randomized, controlled clinical pilot trial will evaluate the effects associated with in-office use of closed-loop, acoustic stimulation neurotechnology (High-resolution, relational, resonance-based, electroencephalic mirroring; HIRREM), compared with acoustic stimulation not linked to brainwaves (ambient nature sounds), for participants with pre-hypertension. Data collection will occur at baseline, and at intervals after completion of the intervention. Outcomes include blood pressure, measures of autonomic cardiovascular regulation, behavioral symptom outcomes, quality of life, alcohol use, and functional performance measures. The primary outcome will be change in blood pressure from baseline to 4-6 weeks after intervention.

Detailed description: This will be a randomized, single site, controlled, pilot clinical trial, to evaluate the effects of in-office use of a closed-loop, allostatic, acoustic stimulation neurotechnology (High-resolution, relational, resonance-based, electroencephalic mirroring; HIRREM), compared with acoustic stimulation not linked to brainwaves (ambient nature sounds). Assuming a potential drop-out rate of 20%, up to 24 subjects will be enrolled to achieve a goal of having at least 20 subjects (10 per group) complete the study, per protocol. Patients who have blood pressures between 120-139 mm/Hg systolic, and/or 80-89 mm/Hg diastolic, as documented by their health care providers on two separate occasions, and no other exclusions, will be randomly assigned to receive either 8-16 sessions of either acoustic stimulation linked to brainwave activity (HCC), or acoustic stimulation not linked to brainwave activity (NCC), over a maximum of 4 weeks, with both groups continuing their current care throughout. There will be pre- and post-intervention data collection to include systolic and diastolic BP, and many secondary outcome measures including measures of autonomic cardiovascular regulation (continuous recording of BP and HR for calculation of measure of HRV and BRS), behavioral symptom outcomes (ISI, PSQI, ESS, CES-D, GAD-7, PCL-C, PSS), quality of life measure (QOLS), alcohol use (Audit C), and function performance measures (drop stick reaction testing, and grip strength). All measures will be collected at an enrollment visit (V1), and the intervention will begin 1-14 days later. BP and HR recordings will also be repeated prior to the start of the 7th session. Post-intervention data collections will be obtained at 1-7 days (V2), 4-6 weeks (V3, primary outcome), and 12-14 weeks (V4) following completion of the intervention. The primary outcome will be differential change in the systolic and diastolic BP from V1 to V3. Additional follow up (V4) will evaluate durability of effects. Following V4, those in the NCC group will be offered the opportunity to cross over to receive a course of HCC, and will continue to be followed for data collections at 1-7 days (V5), 4-6 weeks (V6), and 12-14 weeks (V7) after completing their crossover HCC sessions. Linear mixed models (LMMs) will be used to contrast longitudinal changes in systolic and diastolic blood pressure between the HCC and NCC groups. Mean contrasts will be used to compare the changes in blood pressures between groups from V1 to V3, our primary test of efficacy. Additional mean contrasts will be constructed to evaluate the consistency of any benefit of HIRREM through subsequent visits beyond V3. Comparisons of changes in all secondary outcomes will be assessed in a similar fashion.

Eligibility criteria: Inclusion Criteria:

* Men and women, ≥ 18 years of age, with pre-hypertension, who have systolic BP ranging from 120-139 mm/Hg, or who have diastolic BP ranging from 80-89 mm/Hg.

Exclusion Criteria:

* Blood pressure values that are outside of the range for prehypertension at the enrollment visit.
* 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.
* Prior diagnosis of hypertension.
* Ongoing need for medical treatment for hypertension, or for the use of medications commonly used for treatment of hypertension.
* Known cardiovascular disease.
* Known seizure disorder.
* Known or anticipated pregnancy (females of childbearing age will be tested for pregnancy prior to randomization).
* 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.

Primary outcomes:
measure: Blood Pressure
timeFrame: Data used for analysis of primary outcome is collected at the enrollment visit, 1-7 days after the intervention is completed, 4-6 weeks after the intervention is completed, and 12-14 weeks after completion of the intervention
Secondary outcomes:
measure: Insomnia Severity Index (ISI)
timeFrame: Data used for analysis of secondary outcome is collected at the enrollment visit, 1-7 days after the intervention is completed, 4-6 weeks after the intervention is completed, and 12-14 weeks after completion of the intervention
measure: Pittsburgh Sleep Quality Index (PSQI)
timeFrame: Data used for analysis of secondary outcome is collected at the enrollment visit, 1-7 days after the intervention is completed, 4-6 weeks after the intervention is completed, and 12-14 weeks after completion of the intervention
measure: Epworth Sleepiness Score (ESS)
timeFrame: Data used for analysis of secondary outcome is collected at the enrollment visit, 1-7 days after the intervention is completed, 4-6 weeks after the intervention is completed, and 12-14 weeks after completion of the intervention
measure: Center for Epidemiologic Studies Depression Scale (CES-D)
timeFrame: Data used for analysis of secondary outcome is collected at the enrollment visit, 1-7 days after the intervention is completed, 4-6 weeks after the intervention is completed, and 12-14 weeks after completion of the intervention
measure: Generalized Anxiety Disorder-7 (GAD-7)
timeFrame: Data used for analysis of secondary outcome is collected at the enrollment visit, 1-7 days after the intervention is completed, 4-6 weeks after the intervention is completed, and 12-14 weeks after completion of the intervention
measure: PTSD Checklist for Civilians (PCL-C)
timeFrame: Data used for analysis of secondary outcome is collected at the enrollment visit, 1-7 days after the intervention is completed, 4-6 weeks after the intervention is completed, and 12-14 weeks after completion of the intervention
measure: Perceived Stress Scale (PSS)
timeFrame: Data used for analysis of secondary outcome is collected at the enrollment visit, 1-7 days after the intervention is completed, 4-6 weeks after the intervention is completed, and 12-14 weeks after completion of the intervention
measure: Quality of Life Scale (QOLS)
timeFrame: Data used for analysis of secondary outcome is collected at the enrollment visit, 1-7 days after the intervention is completed, 4-6 weeks after the intervention is completed, and 12-14 weeks after completion of the intervention
measure: AUDIT-C
timeFrame: Data used for analysis of secondary outcome is collected at the enrollment visit, 1-7 days after the intervention is completed, 4-6 weeks after the intervention is completed, and 12-14 weeks after completion of the intervention
measure: Reaction Testing
timeFrame: Data used for analysis of secondary outcome is collected at the enrollment visit, 1-7 days after the intervention is completed, 4-6 weeks after the intervention is completed, and 12-14 weeks after completion of the intervention
measure: Grip Strength
timeFrame: Data used for analysis of secondary outcome is collected at the enrollment visit, 1-7 days after the intervention is completed, 4-6 weeks after the intervention is completed, and 12-14 weeks after completion of the intervention
Other outcomes:
Locations:
Study officials:
affiliation: Wake Forest University Health Sciences
name: Charles H Tegeler, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Gerdes L, Gerdes P, Lee SW, H Tegeler C. HIRREM: a noninvasive, allostatic methodology for relaxation and auto-calibration of neural oscillations. Brain Behav. 2013 Mar;3(2):193-205. doi: 10.1002/brb3.116. Epub 2013 Jan 14.