Frequently Asked Questions

Physician Experience

Patient Experience

Clinical Trials

Usage Guidelines and Administration

RESPeRATE Miscellaneous


Physician Experience

Q:Can I keep RESPeRATE in my clinic and have patients use it?


A: Yes, we have a Professional Dispensing program that enables you to provide RESPeRATE to your clients -- directly from your clinic. You can choose to loan or rent RESPeRATE to your clients or sell it to them. At the same time, the program fairly compensates you for your time. Please note that the best way for a patient to lower their blood pressure (BP) and sustain that blood pressure is to use it routinely at home.

Q:Will I be able to follow my patients' compliance?


A: Yes. Information about performance and compliance is stored automatically by the device and can be displayed. Patients can record this information for review.

Patient Experience

Q:Can a patient's spouse use the device as well?


A: Yes, a second person can use the device, with the DUO model that has two separate memories to help two people track their progress.

Q:Is RESPeRATE covered by insurance?


A: In the US, at present RESPeRATE is generally not covered by health insurance.

Q:Can patients pay in installments?


A: Yes, in the US and in some other countries, installments are available.

Q:How long should it take a patient to lower their breathing to 10 breaths per minute (BPM)?


A: There is no set amount of time that it should take. The important point is that patients follow the guiding tones as well as possible and the device will automatically adjust to gradually guide to a breathing rate that is comfortable for the user. An experienced user reaches 10 BPM or less within 5 minutes of use.

Q:Can patients call if they are having problems with the device?


A: Yes, InterCure provides unlimited phone support to all patients. A user forum is also available online.

Clinical Trials

Q:By how much will my patients' blood pressure decrease?


A: The average reduction from the pooled results of six clinical trials for hypertensive patients with high BP (>140/90 mmHg) is 14/8 mmHg. However, a number of factors affect the expected reduction: the greater the baseline BP, the older the patient and the more slow breathing time accumulated per week, the greater the reduction.

Q:What is the physiological basis for how the device works?


A: It is primarily a reduction in sympathetic outflow which reduces total peripheral resistance. Please refer to the chapter," Respiration and Blood Pressure" in the American Heart Association's textbook, "Hypertension Primer."

Q:How many clinical trials have been done?


A: Nine studies in hypertension have been completed including double-blind, randomized, controlled studies. See results.

Q:How is RESPeRATE different than a Walkman?


A: RESPeRATE is an interactive device that actively guides a patient in a therapeutic breathing exercise, while a walkman is non-interactive, providing static sound/music. When the use of RESPeRATE was compared to listening to a Walkman in double blind controlled trials, the blood pressure lowering was an average of 14/9 in the treatment group compared to 7/4 for the walkman group. This effect is greater than relaxation alone.

Q:Is there a long-term effect? How long were patients in the trials studied?


A: The longest study was 6 months. As long as patients continue the treatment, using the device routinely, the benefits in lowering blood pressure are maintained. There are people who have been using RESPeRATE for over five years and continue to maintain normal BP.

Q:Is the device safe?


A: No side effects were observed in the clinical trials. See indication for use.

Q:A reduction in blood pressure is obvious if BP is measured right after relaxation therapy


A: In all clinical trials, blood pressure values were measured as next morning results and not directly after the intervention. A sustained, all-day reduction has been showed in a 24-hours ambulatory study.

Q:What types of patients were studied in your clinical trials?


A: Please click here for the pooled characteristics of the patient population.

Q:What percent of the patients in your clinical trials were on medication? Couldn't the results be due to that medication?


A: Two out of three patients were on medication but each patient's regimen was not changed before or during the study, including the control groups, so the reductions demonstrated after treatment with RESPeRATE are in addition to medication.. Statistical analyses of the clinical trial results showed that BP reductions were independent of medication status.

Q:How long does it take to see the blood pressure lowering effect?


A: In our clinical studies, the bulk of the results were seen within 3 to 4 weeks of routine use of the device.

Q:Does RESPeRATE work for all patients?


A: Our studies show that 75% of patients were able to significantly lower their blood pressure. The higher the baseline blood pressure, the older the patient and the more the device is used, the greater the expected reduction in blood pressure.

Usage Guidelines and Administration

Q:What patient populations are most likely to benefit from RESPeRATE?


A: The clinical situations in which RESPeRATE appears particularly useful are: 1) pre-hypertensives and white-coat or labile hypertensives who might benefit from reducing stress and sympathetic activity; 2) patients with isolated systolic hypertension; and 3) resistant hypertensive patients (uncontrolled BP despite use of a diuretic and at least 2 other medications at maximum dosage).

Q:Can patients with respiratory problems use this device as well?


A: If the condition does not allow them to perform deep breathing exercises, they cannot use RESPeRATE, However, CHF pilot studies show improvement in clinical parameters and in patient ability to perform daily activities following these types of exercises, modified to optimize the benefit for CHF patients. At present the device is indicated and cleared only for hypertension and stress management.

Q:Are there any contraindications for using RESPeRATE?


A: None are known. However, there are a number of conditions that require consultation with a physician, Please refer to indications for use.

Q:Is there a preferred time of day to use RESPeRATE?


A: In our clinical studies, patients were instructed to use RESPeRATE in the evening, however there is no reason to believe that any particular time of the day is preferable. It's most important that RESPeRATE is used at a time that is convenient for the patient.

Q:Is there any risk of hypotension?


A: No, our studies have found that BP is not further reduced in patients with normal BP. Clinical trial results show a correlation between baseline BP value and BP reductions.

Q:What is the recommended usage?


A: In order for the treatment to be effective patients need to accumulate at least 40 minutes a week of "slow breathing in the Therapeutic Zone" -the amount of time spent breathing at 10 breaths per minute or less. Larger BP reductions were found to correlate with more intensive use. It is generally recommended that patients attain a goal of 10 minutes of therapeutic breathing per session.

Q:Can a patient accumulate the total 40 minutes a week in other ways, other than using the device daily?


A: Yes. Whatever schedule of use fits best into patients' schedules as long as they achieve a total of at least 40 minutes a week of Therapeutic Breathing time. It's best however, to spread the use out evenly.

Q:What if I (physician) do not have time to explain the product to my patients?


A: The FDA cleared the device for over-the-counter use after accepted clinical data demonstrated that patients successfully operated the device after reading the User Manual without any help or recommendations from physicians. A Quick Guide and User Manual are included with the device and a flash demo and further information is available on the RESPeRATE website. For those who need additional support, our product specialists are available toll-free to provide unlimited phone support.

Q:Will this device encourage my patient to lower or change his medication?


A: You may reconsider a patient's overall hypertension treatment with regards to the BP reductions achieved by the device. As clinical trials show that a sustained BP reduction is attained with 3-4 weeks, it is recommended to reevaluate treatment after that time.

Q:My patients don't even take their medication - how can I get them to comply with RESPeRATE?


A: Generally device-guided treatment is pleasant and relaxing, and most users enjoy using RESPeRATE. Our studies show that compliance is high and it may encourage patients to also be more compliant with their medication.

RESPeRATE Miscellaneous

Q:Is RESPeRATE considered alternative medicine?


A: Although the device represents a new class of treatment, it is not an alternative medicine treatment. Hypertension is a mainstream disorder and RESPeRATE has received clearance from the FDA as an adjunctive treatment for hypertension (together with other pharmacological and/or non-pharmacological interventions.) The device is also validated by numerous published peer reviewed studies and a renowned Scientific Advisory Board.

Q:Is RESPeRATE a biofeedback device?


A: Although RESPeRATE includes elements of biofeedback, it does not represent traditional biofeedback, that typically monitors a physiological parameter that one must then be trained to control. RESPeRATE is interactive, and actually guides and paces the user to effortlessly lower the breathing rate to the "therapeutic zone" (less than 10 breaths per minute). This physical breathing exercise significantly lowers blood pressure by relaxing the muscles surrounding constricted blood vessels.

Q:How many patients are using the device? In the US? Elsewhere? In clinical trials?


A: Over 50,000 use the device globally since receiving clearance for marketing, More than 500 patients have participated in clinical trials in the US, Israel , Italy and Korea. The pooled results of 9 studies are consistent and include more than 300 treated patients.

Q:Do you have FDA approval?*


A: Yes, see indications. RESPeRATE has also been approved by regulatory boards in Europe, Korea, Canada, Thailand, China, Australia, and Israel.

Please note: RESPeRATE should be used as part of your overall health program for achieving goal blood pressure, as recommended by your doctor. RESPeRATE can be safely used in conjunction with medication and lifestyle modifications such as diet and exercise