Actively Recruiting
A Pivotal Study to Evaluate the Effectiveness of Isometric Handgrip Therapy in Elevated Blood Pressure and Hypertensive Subjects
Led by Zona Health, Inc · Updated on 2025-07-10
160
Participants Needed
5
Research Sites
109 weeks
Total Duration
On this page
Sponsors
Z
Zona Health, Inc
Lead Sponsor
E
Emergent Clinical Consulting, LLC
Collaborating Sponsor
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
A Pivotal Study to Evaluate the Effectiveness of Isometric Handgrip Therapy in Elevated Blood Pressure and Hypertensive Subjects
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 22 years or older
- Diagnosed with elevated blood pressure or hypertension confirmed by seated cuff systolic blood pressure
- No antihypertensive medication use for at least 30 days before screening
- Sufficient vision, hearing, and hand strength (minimum 35 units of force in both hands)
- Baseline blood pressure measurements collected and completed device training
- Agreement to avoid blood pressure medications and related supplements during treatment
- Ability to comply with all study procedures and visits
- Able to understand and provide written informed consent
- Systolic blood pressure between 130 and 149 mmHg, with heightened monitoring for 140 mmHg or above
You will not qualify if you...
- Female of childbearing potential not using effective birth control, pregnant, lactating, or planning pregnancy
- Blood pressure of 150 mmHg or higher systolic or over 90 mmHg diastolic
- History of severe heart failure (NYHA class III-IV)
- History or current atrial fibrillation
- Hospitalization for hypertensive emergency with organ dysfunction in past 6 months
- More than 10 mmHg systolic blood pressure difference between arms
- Unstable blood pressure with high variance in weekly readings
- Arm circumference over 45 cm
- Acute illness, infection, or inflammation
- Unstable cardiovascular conditions in past 6 months (e.g., heart attack, stroke)
- History of angina in past 6 months
- History of solid organ transplant
- Secondary hypertension causes (e.g., aldosteronism, Cushing syndrome)
- Participation in another investigational study or planned participation within 6 months
- Any condition that could interfere with study participation or data quality
- Current or prior use of Zona Plus device and handgrip activities
- Plans for more than 10% body weight change during study period
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 5 locations
1
Bayview Research Group
Valley Village, California, United States, 91607
Actively Recruiting
2
AMR Miami
Coral Gables, Florida, United States, 33134
Actively Recruiting
3
Cedar Crosse Research Center
Chicago, Illinois, United States, 60607
Actively Recruiting
4
Circuit Clinical Grave Gilbert
Bowling Green, Kentucky, United States, 42101
Actively Recruiting
5
AMR Knoxville
Knoxville, Tennessee, United States, 37909
Actively Recruiting
Research Team
M
Martyna Stankute
CONTACT
M
Mark Young
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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