Clinical information download area

	Click to Download
Clinical Information Pack (Cover letter, Product Brochure, Clinical Overview)
Clinical Slide Kit for your practice
Clinical Slide kit with narration
Clinical Slide kit with notes
RESPeRATE Full Publication Index
RESPeRATE photos (high resolution)

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

As of February 1^st, 2012 RESPeRATE is available as part of UK drug tariff. A prescription can be filled by any licensed pharmacy and directly via this prescription

Yes, either directly on www.resperate.co.uk or at most Boots pharmacies.

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.

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

Yes. Information about performance and compliance is stored automatically by the device and can be displayed. Patients can record this information for review using a provided Logbook. To maximize patients compliance and to relieve you of any technical issues each prescription also provides a 90-days complementary access to RESPeRATE Cares Personalized Coaching program. See details.

• It's not as easy as it sounds.
• RESPeRATE harnesses the centuries of wisdom that certain breathing exercise if performed correctly can reduce neural sympathetic activity.
• To lower your blood pressure, patients will need to pace the breathing without conscious effort. Yet even the simplest unaided breathing exercises, such as counting, reciting a mantra or consciously observing your breathing, require conscious effort which frequently lead to sympathetic activation and is counterproductive.
• RESPeRATE patented technology guide patients to prolong the exhalation without a conscious effort on their part leading to reduced neural sympathetic activity and lower blood pressure.

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.

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".

Ten studies in hypertension have been completed including double-blind, randomized, controlled studies. See results>>

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 14/8 in the treatment group compared to 7/4 for the walkman group. This effect is greater than relaxation alone.

The longest formal clinical study was 6 months. As long as patients continue the treatment, using the device routinely, the benefits in lowering blood pressure are maintained. In addition, close to 100 testimonials of patients using RESPeRATE for one to ten years have been documented and analyzed. To review the analysis click here

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

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.

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

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.

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

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.

The clinical situations in which RESPeRATE appears particularly useful are:

• Patients aged 65+ with uncontrolled blood pressure in spite of medication
• Diabetic patients with hypertension
• Isolated systolic hypertension
• Hypertensive patients resistant to anti-hypertensive drugs
• Patients with uncontrolled blood pressure, who suffer side effects or refuse medication

If the condition does not allow them to perform deep breathing exercises, they cannot use RESPeRATE, However, a number of CHF studies using a modified RESPeRATE show improvement in clinical parameters and in patient ability to perform daily activities. At present the device is indicated and cleared only for hypertension and stress management.

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

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.

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.

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.

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.

Our product specialists are available toll-free to provide unlimited phone support. 97% of patients say RESPeRATE is easy to use. It comes with an embedded tutorial,a Quick Guide and User Manual. For those who need additional support, we are here.

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.

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.

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 and a CE Mark as an adjunctive treatment for hypertension (together with other pharmacological and/or non-pharmacological interventions). As of February 1^st, 2012 it's included on UK drug tariff after considering the available clinical data as well as potential cost-effectiveness of this novel treatment.

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.

Over 200,000 use the device globally prior to the inclusion of UK drug tariff.

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