The initial substantiation for RESPeRATE’s ability to lower blood pressure safely and effectively and the first FDA clearance was achieved by designing and conducting three controlled, double-blind and randomized studies.^1,4 To evaluate the net-effect of RESPeRATE over relaxation techniques, patients received either the RESPeRATE device or an alternative “therapeutic” control device—a standard walkman—which was substantially similar in appearance and operation to RESPeRATE. These trials demonstrated a significant and sustained reduction in blood pressure using RESPeRATE. Blood pressure reductions in the control group did not achieve the predetermined clinical threshold of 10 mmHg systolic or 5 mmHg diastolic.

InterCure conducted the Elliott study³, employing a protocol designed in consultation with the FDA, to gain its second FDA clearance as an OTC product. In this study, patients received either RESPeRATE and a blood pressure monitor (treatment) or only a blood pressure monitor (control) at their home by courier. This multi-center, double-blind, randomized, controlled trial, was carried out in five centers in the US. The trial demonstrated the efficacy of RESPeRATE without any prior training by a physician. It also demonstrated a clear dose-response relationship between the amount of RESPeRATE exercise (slow breathing time, <10 breaths per minute) and the resulting blood pressure response. The blood pressure reductions were greater as more slow breathing exercise was performed. Appropriate and routine use of the device for 30 minutes a week resulted in significant blood pressure reductions.

To further validate that RESPeRATE provides sustained all-day blood pressure reduction, the Rosenthal and Aydin studies^5,15 used the 24-hour ambulatory blood pressure monitors (ABPM), measuring blood pressure every 20 minutes for 24 hours before and after the 8-week study period. Given that ABPM is considered the most rigorous method for assessing hypertension therapies, such studies are relatively small and are of “pre-post” design—BP reduction at the end of the period compared with baseline. The study results demonstrated similar BP reductions to the initial studies.

The Meles study², performed in one of Italy's premier hypertension clinics in Monza, was designed to further assess the kinetics of blood pressure lowering effect in a home setting, specifically how long it takes to see a significant difference between treatment and control group. The study demonstrated excellent patient compliance and significant reduction in both home and office blood pressure, and ruled out the placebo effect even in highly medicated patients.

The Viskoper study⁶ focused on assessing the RESPeRATE effect in drug-resistant hypertensive patients who had uncontrolled hypertension despite receiving maximum doses of three or more antihypertensive drugs.. It demonstrated that RESPeRATE delivers significant blood pressure reductions, even in these hard-to-treat patients.

The latest two studies, Bae and Schein^8,9 evaluated the safety and efficacy of RESPeRATE in Asians and in the diabetic-hypertensive population respectively. The multi-center study from Korea validates that the therapeutic effect of RESPeRATE is not race dependent. The Schein study, a double-blind, randomized, controlled trial demonstrates RESPeRATE's beneficial effects in Type II diabetics with uncontrolled blood pressure. The study also provided preliminary validation for the reduction of stress with the use of RESPeRATE. Results of the QSD-R survey found a reduction in the total stress score, primarily due to diminished anxiety and fewer physical complains, at the end of the 8 week treatment period.¹⁰

Aside from studies in hypertension, various mechanism of action studies have been performed. They have demonstrated an increase in baroreflex sensitivity, a reduction in sympathetic activity, an increase in arterial compliance and reduction in peripheral resistance.^{11,12,13 ,14}

To inquire about completed and ongoing studies outside of the current hypertension indication, please contact our clinical and regulatory department.