A Pivotal Study to Evaluate the Effectiveness of Isometric Handgrip Therapy in Elevated Blood Pressure and Hypertensive Subjects

July 7, 2025 updated by: Zona Health, Inc
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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

Study subjects randomized to the Zona Plus Device arm will perform isometric therapy with the device with subject compliance monitored through a downloadable electronic memory function built into the device. Study subjects randomized to the control arm will be asked to listen to relaxing music via a mobile app and asked to document their compliance via a patient diary. Subjects in the control arm may be able to crossover to using the Zona Plus device after completion of Study Visit 6. Subjects who have systolic blood pressure between 140mmHG and 149mmHG at baseline will complete three additional study visits for further monitoring. Subjects can expect participation in the study to last between 3 and 8 months.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
160

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

Study Locations

  • United States
    • California
      • Valley Village, California, United States, 91607
    • Florida
      • Coral Gables, Florida, United States, 33134
    • Illinois
      • Chicago, Illinois, United States, 60607
        • Recruiting
        • Cedar Crosse Research Center
        • Contact:
    • Kentucky
      • Bowling Green, Kentucky, United States, 42101
    • Tennessee
      • Knoxville, Tennessee, United States, 37909

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  1. Subject is male or female age 22 or older
  2. Diagnosed with elevated blood pressure or hypertension and verified during Visit #1 by standardized seated cuff SBP
  3. Have not taken antihypertensive medication for ≥30 days prior to the SEPV
  4. Subject is expected to have sufficient vision, hearing, and hand strength (hand strength is demonstrated by a maximum voluntary contraction (MVC) equaling 35 units of force in both hands measured by a dynamometer
  5. Subject has baseline BP measurements collected and completes study device training during Baseline Assessment (Visit #1);
  6. Subject agrees to maintain non-use of medications and over-the-counter (OTC) supplement regimen related to hypertension throughout the treatment phase;
  7. Patient can comply with and agrees to complete all required study procedures, study clinic visits, and associated activities;
  8. Patient must be able to understand and give written informed consent in the language provided;
  9. Subject must have SBP of 130 to ≤149 mmHg, if subjects present with SBP reading of ≥140mmHg they will receive heightened monitoring throughout the first month of the study

Exclusion Criteria:

  1. Subject is a female of childbearing potential (e.g., not postmenopausal for at least one year or has not had a hysterectomy or tubal ligation) not using medically effective birth control (e.g., hormonal methods in use at least 30 days prior to screening or barrier methods such as condom and spermicide in use at least 14 days prior to visit 1) or is pregnant, lactating, or plans to become pregnant during the study).
  2. BP ≥150 mmHg (systolic) and/or >90 mmHg (diastolic)
  3. A history of heart failure with current New York Heart Association (NYHA) class III- IV functional classification
  4. Currently has, or has had a history, of atrial fibrillation, in accordance with 2007 Heart Rhythm Society (HRS)/European Heart Rhythm Association (EHRA)/European Cardiac Arrhythmia Society (ECAS) guidelines
  5. Patient has experienced hospitalization due to a hypertensive emergency, with impending or progressive target organ dysfunction (i.e., renal dysfunction, left ventricular hypertrophy or CNS involvement) within the past six (6) months
  6. A >10 mmHg difference in seated cuff SBP between the right and left arms collected during the SEPV;
  7. Unstable BP, defined as >5 mmHg variance between any two (2) consecutive weekly readings (with a maximum of four (4) attempts) to determine a baseline BP measurement ;
  8. Arm circumference greater than 45 cm;
  9. Acute illness, infection, or inflammation
  10. Presence of any unstable cardiovascular disorder, such as MI, unstable angina, significant arrhythmia, stroke, or TIA; within the last six (6) months, or other serious comorbidity that would be likely to impact life expectancy to less than one (1) year or limit patient cooperation or study compliance;
  11. A history of rest or exertional angina pectoris in the previous six (6) months;
  12. History of solid organ transplant
  13. Any secondary form of hypertension (HTN) etiology, including but not limited to primary aldosteronism, chronic steroid therapy and Cushing syndrome, pheochromocytoma, aorta coarctation or untreated thyroid or parathyroid disease;
  14. Concurrent participation in an investigational clinical study that has not completed the follow-up period or planned participation in another study within the next six (6) months;
  15. Patient has any other condition or personal circumstance that, in the judgment of the investigator, might interfere with the collection of complete, good quality data or the completion of the research study;
  16. Patients who currently own or have owned another Zona Plus device and are, or have been, voluntarily performing the isometric handgrip activities.
  17. Subject plans for greater than 10% of body weight loss/gain (10% of body weight over a 6-month period) during the study

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Investigational
Zona Plus Device
Device: Zona Plus Device
Use of the Zona Plus device involves performing isometric handgrip exercise therapy. Isometric exercise is the type of exercise in which you tense or tighten your muscle without seeing it change in length.
Active Comparator: Control
Relaxing music
Other: Relaxing Music App
Relaxing music will be made available through a mobile app that users access via their smart phone or tablet. Subjects will have the option to listen to 5 different music genres that support relaxation (Classical, Nature, Movie Soundtracks, Jazz, Reggae).

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Time Frame
Compare the change from baseline in mean seated cuff systolic blood pressure (SBP) after 10 weeks of treatment between patients randomized to the Zona Plus device and the patients in the control group.
Time Frame: 10 weeks
10 weeks

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Time Frame
To compare the change from baseline in seated cuff diastolic blood pressure ("DBP") after 10 weeks of treatment between patients randomized to the Zona Plus device and the patients in the control group.
Time Frame: 10 weeks
10 weeks
The percentage of patients randomized to the Zona Plus device who achieve a clinically significant SBP reduction (defined as ≥5 mmHg) at Week 10 compared to control.
Time Frame: 10 weeks
10 weeks
The percentage of patients randomized to the Zona Plus device who achieve a clinically significant DBP reduction (defined as ≥3 mmHg) at Week 10 compared to control.
Time Frame: 10 weeks
10 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Zona Health, Inc

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Emergent Clinical Consulting, LLC

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
March 27, 2025

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
May 1, 2027

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
May 1, 2027

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
February 20, 2025

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 20, 2025

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
February 25, 2025

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
July 10, 2025

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 7, 2025

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
July 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • Zona-002

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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