Scientific Rigor

Well-controlled clinical trials before and after FDA approval have validated RESPeRATE's blood pressure lowering claim. Anticipating initial skepticism regarding the efficacy of device-guided paced breathing, special attention was given to study design and understanding of the physiological mechanisms.

Study Design & Population

• The studies compared those who used RESPeRATE for 15 minutes a day for 8 weeks to a control group, using a walkman with relaxing music¹, home blood pressure monitoring ^2,3 or both.⁴
• Clinical studies design included five randomized, controlled studies^1,3,4,8, one controlled study² and four open-label studies.^5,6,9,14
• There were 507 participants, average age of 58.
• 78% of participants were already taking blood pressure medications, a third of whom were taking 3 or more medications.
• The average initial office blood pressure was 150/90 mmHg despite other therapies; diet, exercise and/or medications.

More about the study design

Summary of Clinical Findings

• RESPeRATE users with uncontrolled blood pressure (BP) experienced a significant decrease in office blood pressure with average reduction of 14/8 mmHg.
• Control treatment reduction was 9/4 mmHg, significantly less than with RESPeRATE (p = 0.008 and p = 0.002, respectively for systolic and diastolic blood pressures).
• The results were similar across gender, race and medication status.
• No side effects observed in any of the 10 clinical trials. With more than 100,000 devices in market, InterCure has not received any reportable or major adverse reaction reports.
• Correlation was found between the decline in BP and the aggregate duration of slow breathing; greater use of RESPeRATE (and accumulation of slow breathing time) led to better BP reductions.
• A clinically significant, sustained reduction in blood pressure typically occurred in 3 to 4 weeks.
• Greater reductions in office blood pressure occurred in older individuals and those with higher baseline blood pressures, whether taking antihypertensive medication or not.
• Home blood pressure measurements (for up to 6 months of use⁷) and 24-hours ambulatory blood pressure monitoring^5,15 have verified an all-day, lasting blood pressure lowering effect.
  
• Patients' ability to operate the RESPeRATE device with self-training alone, and to use it routinely and over time, was established objectively using the device's internal memory and verified by market surveys among users.
• In order to maintain reduced blood pressure over time, patient is required to continue using the device on a regular basis (at least 3-4 times per week to attain at least 40 minutes of slow breathing).

Consistent Results in 10 Independent Clinical Trials

Box-and-whiskers plot of change in systolic blood pressure to 8-week daily use of the RESPeRATE in 10 independent clinical studies (in US, Israel, Italy, Korea and Turkey) for patients which operated the device appropriately.

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