Status:
WITHDRAWN
HIRREM for Pre-Hypertension
Lead Sponsor:
Wake Forest University Health Sciences
Conditions:
Prehypertension
Blood Pressure
Eligibility:
All Genders
18+ years
Phase:
NA
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-ba...
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, ...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
March 1 2018
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 1 2019
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT03332043
Start Date
March 1 2018
End Date
October 1 2019
Last Update
March 7 2018
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