Handgrip Therapy for High Blood Pressure

Recruiting in Palo Alto (17 mi)

+8 other locations

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Academic

Waitlist Available

Sponsor: Zona Health, Inc

No Placebo Group

Trial Summary

What is the purpose of this trial?

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.

Research Team

Eligibility Criteria

This trial is for adults aged 22 or older with high blood pressure (130 to ≤149 mmHg systolic) who haven't taken antihypertensive meds for at least 30 days. Participants must not be on hypertension-related OTC supplements, have good vision, hearing, and hand strength. Pregnant women, those with severe heart issues or recent cardiovascular events, and individuals with unstable blood pressure are excluded.

Inclusion Criteria

I have been diagnosed with high blood pressure.

Subject has baseline BP measurements collected and completes study device training during Baseline Assessment (Visit #1)

Patient must be able to understand and give written informed consent in the language provided

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Exclusion Criteria

BP ≥150 mmHg (systolic) and/or >90 mmHg (diastolic)

I am a woman who could become pregnant and am not using or plan to use effective birth control during the study.

I have severe heart failure.

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Treatment Details

Interventions

Zona Plus Device (Behavioural Intervention)

Trial OverviewThe study tests the Zona Plus handgrip therapy device against an auditory relaxation app in managing high blood pressure without medication. Half of the participants will also monitor their blood pressure at home. It's a randomized trial across multiple centers to assess safety and effectiveness.

Participant Groups

2Treatment groups

Experimental Treatment

Active Control

Group I: InvestigationalExperimental Treatment1 Intervention

Zona Plus Device

Group II: ControlActive Control1 Intervention

Relaxing music