Handgrip Therapy for High Blood Pressure
Trial Summary
Will I have to stop taking my current medications?
The trial requires that participants do not take any medications or over-the-counter supplements related to high blood pressure during the study.
How does the Zona Plus Device treatment for high blood pressure differ from other treatments?
What is the purpose of this trial?
The study will be a multi-center, randomized clinical trial to evaluate the safety and efficacy of using the Zona Plus handgrip therapy device compared to the use of an auditory relaxation therapy for treatment of high blood pressure and hypertension in subjects who are not currently taking antihypertensive medications. Half of the study subjects will also be randomized to record blood pressure at home throughout the study.
Eligibility Criteria
This trial is for adults aged 22 or older with high blood pressure (130 to ≤149 mmHg systolic) who haven't taken antihypertensive meds for at least 30 days. Participants must not be on hypertension-related OTC supplements, have good vision, hearing, and hand strength. Pregnant women, those with severe heart issues or recent cardiovascular events, and individuals with unstable blood pressure are excluded.Inclusion Criteria
Exclusion Criteria
Timeline
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants are randomized to either the Zona Plus Device arm for isometric therapy or the control arm for auditory relaxation therapy
Crossover
Control arm participants may crossover to using the Zona Plus device after Study Visit 6
Follow-up
Participants are monitored for safety and effectiveness after treatment
Treatment Details
Interventions
- Zona Plus Device
Find a Clinic Near You
Who Is Running the Clinical Trial?
Zona Health, Inc
Lead Sponsor
Emergent Clinical Consulting, LLC
Industry Sponsor