NCT06843577

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

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 160 (estimated)
• Sponsor: Zona Health, Inc · Industry
• Sex: All
• Age: 22 Years
• Healthy volunteers: Not accepted

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.

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.

Conditions

• Elevated Blood Pressure
• Hypertension

Interventions

Type	Name	Description
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.
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).

Timeline

• Start date: 2025-03-27
• Primary completion: 2027-05-01
• Completion: 2027-05-01
• First posted: 2025-02-25
• Last updated: 2025-07-10

Locations

5 sites across 1 country: United States

Regulatory

• FDA-regulated device study