A Pivotal Study to Evaluate the Effectiveness of Isometric Handgrip Therapy in Elevated Blood Pressure and Hypertensive Subjects

Conditions

• Elevated Blood Pressure
• Hypertension

Eligibility Criteria

Sex

ALL

Age

22 Years - N/A

Healthy Volunteers

Not accepted

Interventions

• Zona Plus Device — DEVICE
  Use of the Zona Plus device involves performing isometric handgrip exercise therapy. Isometric exercise is the type of exercise in which you tense or tighten your muscle without seeing it change in length.
• Relaxing Music App — OTHER
  Relaxing music will be made available through a mobile app that users access via their smart phone or tablet. Subjects will have the option to listen to 5 different music genres that support relaxation (Classical, Nature, Movie Soundtracks, Jazz, Reggae).

Study Details

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.

Key Dates

First listed

Feb 25, 2025

Start date

Mar 27, 2025

Status verified

Jul 2026

Primary completion

Sep 30, 2027

Completion

Feb 29, 2028

Study Design

Enrollment

160 participants (estimated)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Arms

• Experimental: Investigational
  Zona Plus Device
• Active Comparator: Control
  Relaxing music

Primary Outcome Measure

Compare the change from baseline in mean seated cuff systolic blood pressure (SBP) after 10 weeks of treatment between patients randomized to the Zona Plus device and the patients in the control group. [ Time Frame: 10 weeks ]

Central Contacts

• Brandi Caughman
  610-454-7200
  [email protected]
• Mark Young
  (888) 804 7993
  [email protected]

Locations (10)

Find similar trials in Valley Village, CA

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