RecruitingNot ApplicableNCT06843577

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


Sponsor

Zona Health, Inc

Enrollment

160 participants

Start Date

Mar 27, 2025

Study Type

INTERVENTIONAL

Conditions

Summary

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

Min Age: 22 Years

Plain Language Summary

Simplified for easier understanding

This study is testing whether squeezing a device (isometric handgrip therapy) for short periods each day can help lower blood pressure in people with elevated or high blood pressure, without using medication. **You may be eligible if...** - You are 22 years or older - You have elevated blood pressure or been diagnosed with hypertension - You have not taken blood pressure medication in the past 30 days - You have adequate vision, hearing, and hand strength **You may NOT be eligible if...** - You are currently on blood pressure medication - You lack the hand strength to complete the grip exercises - You have conditions that prevent safe participation in the exercise protocol Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

Interested in this trial?

Get notified about updates and connect with the research team.

Interventions

DEVICEZona 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.

OTHERRelaxing 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).


Locations(5)

Bayview Research Group

Valley Village, California, United States

AMR Miami

Coral Gables, Florida, United States

Cedar Crosse Research Center

Chicago, Illinois, United States

Circuit Clinical Grave Gilbert

Bowling Green, Kentucky, United States

AMR Knoxville

Knoxville, Tennessee, United States

View Full Details on ClinicalTrials.gov

For the most up-to-date information, visit the official listing.

Visit

NCT06843577


Related Trials