Handgrip Therapy for High Blood Pressure

Recruiting at 8 trial locations

Overseen By Mark Young

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Zona Health, Inc

Must not be taking: Antihypertensives

Disqualifiers: Pregnancy, Heart failure, Atrial fibrillation, Hypertensive emergency, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 6

Duration: 3-8 months

160 Participants Needed

What You Need to Know Before You Apply

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.

Will I have to stop taking my current medications?

The trial requires that participants do not take any medications or over-the-counter supplements related to high blood pressure during the study.

How does the Zona Plus Device treatment for high blood pressure differ from other treatments?

The Zona Plus Device is unique because it uses handgrip therapy, which involves squeezing a device to help lower blood pressure. This method is different from traditional treatments like medication, as it focuses on physical exercise to improve cardiovascular health. ^{1 2 3 4 5}

Are You a Good Fit for This Trial?

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

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.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants are randomized to either the Zona Plus Device arm for isometric therapy or the control arm for auditory relaxation therapy

3-8 months

6 visits (in-person)

Crossover

Control arm participants may crossover to using the Zona Plus device after Study Visit 6

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Zona Plus Device

Trial Overview The 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.

How Is the Trial Designed?

Group I: Investigational Experimental Treatment 1 Intervention

Zona Plus Device

Group II: Control Active Control 1 Intervention

Relaxing music

Who Is Running the Clinical Trial?

Zona Health, Inc

Lead Sponsor

Trials

2

Recruited

310+

Emergent Clinical Consulting, LLC

Industry Sponsor

Trials

6

Recruited

2,900+

Citations

1. England pubmed.ncbi.nlm.nih.gov

Accuracy of the HoMedics Walgreens Deluxe Arm Blood Pressure device (WGNBPA-540) compared with auscultation in 85 individuals. [2019]

2. England pubmed.ncbi.nlm.nih.gov

Validation of the fully automated Pangao PG-800B68 upper-arm device according to the European Society of Hypertension International Protocol revision 2010. [2019]

3. United States pubmed.ncbi.nlm.nih.gov

A preoperative modified Allen test result may be associated with long term mortality after hemodialysis access construction. [2022]

4. France pubmed.ncbi.nlm.nih.gov

[Measurement of blood pressure in obese patients: reliability and value of finger measurement (Finapres)]. [2009]

5. United States pubmed.ncbi.nlm.nih.gov

Physiological influences on continuous finger and simultaneous intra-arterial blood pressure. [2019]