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Behavioural Intervention

Zona Plus Device for High Blood Pressure

N/A
Waitlist Available
Research Sponsored by Zona Health, Inc
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up change from baseline to day 160 ± 4 days
Awards & highlights

Summary

This is a double-blind, sham-controlled clinical trial assessing the effectiveness of personalized isometric handgrip device therapy. Approximately 230 patients who present with a Systolic Blood Pressure reading of ≤ 149mmHg and who have not taken any antihypertensive medication for more than 30 days will be enrolled.

Eligible Conditions
  • High Blood Pressure

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~change from baseline to day 160 ± 4 days
This trial's timeline: 3 weeks for screening, Varies for treatment, and change from baseline to day 160 ± 4 days for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Change from Baseline in Systolic Blood Pressure to Day 70 ± 2 Days
Secondary outcome measures
Change from Baseline in Diastolic Blood Pressure to Day 70 ± 2 Days
Comparison of Heart Rate between Zona Plus nominal device and Placebo controlled device
Percentage change from Baseline in Diastolic Blood Pressure reduction at Day 70 ± 2 Days
+3 more

Trial Design

2Treatment groups
Experimental Treatment
Placebo Group
Group I: Zona Plus - Active - "Normal Grip"Experimental Treatment1 Intervention
Using the Zona Plus Device, the patient will perform a twelve-minute isometric handgrip therapy session at approximately the same time each day . After an initial handgrip strength assessment (the session calibration), a two-minute isometric routine is performed four times, two sessions per hand, with a one-minute non-grip, or rest session between each isometric routine.
Group II: Control Device - Sham - "Weaker Grip"Placebo Group1 Intervention
Using the Zona Sham Control Device the patient will perform a twelve-minute isometric handgrip therapy session at approximately the same time each day. After an initial handgrip strength assessment (the calibration), a two-minute isometric routine is performed four times, two sessions per hand, with a one-minute non-grip, or rest session between each isometric routine.

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Who is running the clinical trial?

Zona Health, IncLead Sponsor
Research & Development Concierge CompanyUNKNOWN
Glenn Loomis, MDStudy DirectorResearch & Development Concierge
~28 spots leftby Sep 2025
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