A Pivotal Study to Evaluate the Effectiveness of Isometric Handgrip Therapy in Elevated Blood Pressure and Hypertensive Subjects
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.
• Subject is male or female age 22 or older
• Diagnosed with elevated blood pressure or hypertension and verified during Visit #1 by standardized seated cuff SBP
• Have not taken antihypertensive medication for ≥30 days prior to the SEPV
• 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
• Subject has baseline BP measurements collected and completes study device training during Baseline Assessment (Visit #1);
• Subject agrees to maintain non-use of medications and over-the-counter (OTC) supplement regimen related to hypertension throughout the treatment phase;
• Patient can comply with and agrees to complete all required study procedures, study clinic visits, and associated activities;
• Patient must be able to understand and give written informed consent in the language provided;
• 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