PrehypertensionNCT03332043
HIRREM for Pre-Hypertension
A study testing HIRREM and Ambient Nature Sounds in people with Prehypertension and Blood Pressure, run by Wake Forest University Health Sciences.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Prehypertension, Blood Pressure, Autonomic Nervous System Imbalance
- What is being tested?
- HIRREM and Ambient Nature Sounds
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- Mar 2018to Oct 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
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
- 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.
Who cannot join
- 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.
Show all 12Show fewer
- 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.
About this study
Official title: High-resolution, Relational, Resonance-based, Electroencephalic Mirroring (HIRREM) for Pre-Hypertension: A Randomized, Controlled Clinical Trial
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.
Read the 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.
- Conditions
- Prehypertension, Blood Pressure, Autonomic Nervous System Imbalance, Cardiovascular Risk Factor, Cardiovascular Diseases, Brain Diseases
- Being tested
- HIRREM, Ambient Nature Sounds
- Keywords
- HIRREM, Neurotechnology, Closed-loop, Acoustic stimulation, Allostatic, Heart rate variability, Baroreflex sensitivity, Blood pressure management, Autocalibration, Neural oscillations, Relaxation, Electroencephalic
- Medical subject headings
- Prehypertension, Cardiovascular Diseases, Brain Diseases
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
HIRREM (Brain State Technologies, Scottsdale, AZ) is a closed-loop, allostatic, acoustic stimulation neurotechnology that uses software-guided algorithmic analysis to identify and translate selected brain frequencies into audible tones of varying pitch and timing, to support real-time self-optimization of brain activity.
Ambient Nature SoundsOther
Also called Wave Aid
Digitally recordings of various ambient nature sounds such as a stream, waterfall, ocean waves, or rainfall, are provided via ear buds.
| Study group | Role | What they receive |
|---|---|---|
| HIRREM | Experimental | Subjects in the experimental arm will receive an in-office, open-label course of acoustic stimulation linked to brain activity (High-resolution, relational, resonance-based, electroencephalic mirroring, HIRREM). Receives: Device: HIRREM |
| Ambient Nature Sounds | Active comparator | Subjects in the active comparator arm will receive an in-office, open-label course of acoustic stimulation not linked to brain activity (ambient natures sounds). Receives: Other: Ambient Nature Sounds |
What is being measured
The primary outcome is the main question the study is designed to answer.
Blood Pressure
Change in systolic and diastolic blood pressure
Measured: 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 (11)
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.
Measured: 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
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: 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
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.
Measured: 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
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.
Measured: 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
Generalized Anxiety Disorder-7 (GAD-7)
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.
Measured: 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
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 related to military service. 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: 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
Perceived Stress Scale (PSS)
The Perceived Stress Scale (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. Items were designed to tap how unpredictable, uncontrollable, and overloaded respondents find their lives. The scale, with answers rated from 0-4, also includes a number of direct queries about current levels of experienced stress.
Measured: 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
Quality of Life Scale (QOLS)
The Quality of Life Scale (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: 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
AUDIT-C
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 3 or more in women and a score of four or more in men is suggestive of hazardous drinking or active alcohol use disorders. This form is modified from the longer, 10-item AUDIT instrument.
Measured: 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
Reaction Testing
Reaction testing will be evaluated by a drop-stick, clinical reaction time apparatus. It is constructed from a meter stick covered in friction tape with gradations. The modified meter stick is fixed to a weighted rubber cylinder. 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, subjects perform eight trials, and a mean distance value is used for analysis. 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.
Measured: 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
Grip Strength
Grip strength will be evaluated using a hydraulic hand dynamometer (Baseline Hydraulic Hand Dynamometer). The greatest force generated during three trials will be used for analysis.
Measured: 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
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Nov 2017
- Study startMar 2018 (estimated)
- Primary completionOct 2018 (estimated)
- Study completionOct 2019 (estimated)
Why it stopped: Pre-hypertension no longer exists
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for PrehypertensionStudies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Wake Forest University Health Sciences
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Charles H Tegeler, MD, Principal investigator, Wake Forest University Health Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03332043
- Sponsor's protocol ID
- IRB00044598
- Status last verified
- Mar 2018
- First submitted
- 1 Nov 2017
- Last updated
- 7 Mar 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No: Data will be shared in publications and presentations. No plan to formally make individual participant data available for this study.
Publications
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.
PubMed 23532171
Study at a glance
From the registry record, last updated by the sponsor on 7 Mar 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- High-resolution, Relational, Resonance-based, Electroencephalic Mirroring (HIRREM) for Pre-Hypertension: A Randomized, Controlled Clinical Trial
- ClinicalTrials.gov ID
- NCT03332043
- Acronym / sponsor ID
- IRB00044598
- 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
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Pre-hypertension no longer exists
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Wake Forest University Health SciencesUniversity, hospital or other
- Study start
- Mar 2018 (estimated)
- Primary completion
- Oct 2018 (estimated)
- Study completion
- Oct 2019 (estimated)
- First posted
- 6 Nov 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| HIRREM | Experimental | Device: HIRREMSubjects in the experimental arm will receive an in-office, open-label course of acoustic stimulation linked to brain activity (High-resolution, relational, resonance-based, electroencephalic mirroring, HIRREM). |
| Ambient Nature Sounds | Active comparator | Other: Ambient Nature SoundsSubjects in the active comparator arm will receive an in-office, open-label course of acoustic stimulation not linked to brain activity (ambient natures sounds). |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- 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.
Key exclusion criteria (12 listed)
- 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.
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 mirroringHIRREM (Brain State Technologies, Scottsdale, AZ) is a closed-loop, allostatic, acoustic stimulation neurotechnology that uses software-guided algorithmic analysis to identify and translate selected brain frequencies into audible tones of varying pitch and timing, to support real-time self-optimization of brain activity. | Device | HIRREM |
| Ambient Nature SoundsAlso: Wave AidDigitally recordings of various ambient nature sounds such as a stream, waterfall, ocean waves, or rainfall, are provided via ear buds. | Other | Ambient Nature Sounds |
Primary outcome
Blood Pressure
Time frame: 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
Change in systolic and diastolic blood pressure
11 secondary outcomes
Insomnia Severity Index (ISI)
Time frame: 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
Pittsburgh Sleep Quality Index (PSQI)
Time frame: 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
Epworth Sleepiness Score (ESS)
Time frame: 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
Center for Epidemiologic Studies Depression Scale (CES-D)
Time frame: 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
Generalized Anxiety Disorder-7 (GAD-7)
Time frame: 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
PTSD Checklist for Civilians (PCL-C)
Time frame: 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
Perceived Stress Scale (PSS)
Time frame: 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
Quality of Life Scale (QOLS)
Time frame: 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
AUDIT-C
Time frame: 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
Reaction Testing
Time frame: 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
Grip Strength
Time frame: 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
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Mar 2018.
- Background: PubMed 23532171Gerdes 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.
- HIRREM research webpageLink provided by the sponsor.
- Individual participant dataSharing planned: No. Data will be shared in publications and presentations. No plan to formally make individual participant data available for this study.
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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 H Tegeler, MD principal investigator
Wake Forest University Health Sciences
Questions about this trial
What is this clinical trial studying?
A study testing HIRREM and Ambient Nature Sounds in people with Prehypertension and Blood Pressure, run by Wake Forest University Health Sciences.
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 1 inclusion and 12 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: withdrawn, as of the sponsor's last update on 7 Mar 2018. Status can change between updates, so confirm with the study contact before making plans.
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?
The study was withdrawn before enrolling participants, so there are no results.
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?
Blood Pressure (time frame: 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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03332043, which also lists 1 linked publication.
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 7 Mar 2018.