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 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).
BP ≥150 mmHg (systolic) and/or >90 mmHg (diastolic)
A history of heart failure with current New York Heart Association (NYHA) class III- IV functional classification
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
Zona Health, Inc
Lead sponsor
Emergent Clinical Consulting, LLC
Collaborator