DESCRIPTION

The RESPeRATE device is a non-invasive, non-drug therapeutic device to perform breathing exercises as an adjunctive treatment for hypertension. It includes a compact-processing unit, headphones, and a respiration sensor on an elastic belt.

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CLINICAL PHYSIOLOGY

Slow and deep breathing is known to acutely modulate both the cardiovascular and nervous systems. 1,2 The greater lung inflation associated with deep and slow breathing stimulates slowly-adapting pulmonary stretch receptors. This stimulation triggers a reflex loop (baroreflex) that leads to blood pressure reduction. 3,4,5 The sustained blood pressure reductions observed after routine exercises with RESPeRATE™ are analogous to the adaptive blood pressure response achieved through routine aerobic exercises or by using CPAP in obstructive sleep apnea. 6,7

The results of three randomized, controlled clinical studies support the use of RESPeRATE™. 8,9 The studies showed that RESPeRATE™ treatment along with prescribed hypertension medications resulted in a typical reduction of 12 mmHg systolic and 8 mmHg diastolic with just six weeks of daily treatment. Pooled trial data, as well as additional trial data, also have shown that this blood pressure reduction increases both with age and with higher initial blood pressure ( Tables 1 & 2 ). 8,9,10 Use of the device has been shown to lower blood pressure for patients who were taking hypertensive medications as well as for those who were not taking medication to control blood pressure. No side effects or adverse reactions were reported.

Table 1: Study population characteristics. *
 
RESPeRATE
Treatment
N=50 		Relaxation
Treatment
N=48
Age (years)
55.6 54.4
% Males
62% 48%
27.9 28.2
78% 69%
Systolic BP (mmHg)
157.7 154.8
Diastolic BP (mmHg)
96.2 93.5
Mean BP (mmHg)
116.7 113.9
Heart Rate (bpm)
74.3 74.5
* Comparison by treatment group gives no significant differences (p>0.05)

Table 2: Significance of blood pressure response to RESPeRATE™ treatment (AVG ± SEM), relative to efficacy criteria and age.
BP Reduction All Patients
(n=50) 		Age>50
(n=33) 		Age>60
(n=20)
Systolic BP (mmHg) 12.4±1.9 15.8±2.0 17.0±2.7
Diastolic BP (mmHg) 7.8±1.1 9.3±1.2 10.9±1.4
p-Value * 0.01 0.002 <0.001
* Obtained by one-sample t-test with respect to each threshold

INDICATIONS AND USAGE

The RESPeRATE device is intended for use as a relaxation treatment for the reduction of stress by leading the user through interactively guided and monitored breathing exercises. The device is indicated for use only as an adjunctive treatment for high blood pressure under the direction of a physician, together with other pharmacological and/or non-pharmacological interventions as prescribed by the physician.

CONTRAINDICATIONS

None known.

PRECAUTIONS

Do not use RESPeRATE when you need to be alert, or to concentrate, or when using heavy equipment. Do not use RESPeRATE while driving. Breathe naturally throughout the exercise. Excessive deep breathing may cause dizziness and palpitations. This device has not been studied in patients with respiratory disease, diabetes, atrial fibrillation, active ischemic heart disease/unstable angina, congestive heart failure, stroke, chronic renal failure, or major organ failure.

DOSAGE AND ADMINISTRATION

Physicians should write a prescription and fax it to the mail order pharmacy @312-421-5082. Patients should call 877-988-9388 for delivery.

REFERENCES

  1. Daly M de B. "Interactions between respiration and circulation." In: Cherniack NS & Widdicombe JG (Eds). Handbook of Physiology. (Bethesda, MD: Am Physiol Soc, 1986): 529-594.
  2. St Croix CM, Satoh M, Morgan BJ, Skatrud JB & Dempsy JA. "Role of respiratory motor output in within-breath modulation of muscle sympathetic nerve activity in human." Circulation Research, 1999; 85: 457-469.
  3. Langhorst P, Schulz G, & Lambertz M. "Integrated control mechanism for cardiorespiratory and somatomotor functions in the reticular formation of the lower brain stem." In: Grossman P, Janssen KHL, & Vaitl D (Eds). Cardiorespiratory and Cardiosmoatic Psychophysiology. (New York: Plenum Press, 1983): 9-37.
  4. Daly M de B. "Aspects of the integration of the respiratory and cardiovascular system." In: Jordan D & Marshal J (Eds). Cardiovascular Regulation. (London: Portland Press, 1995): 15-35.
  5. Pitzalis MV, Mastopasqua F, Massari F et al. "Effect of respiratory rate on the relationship between RR interval and systolic blood pressure fluctuations: a frequency-dependent phenomenon." Cardiovasc Res, 1998; 38: 332-339.
  6. Tanaka H, Reiling MJ, & Seals DR. "Regular walking increases peak limb vasodilatory capacity of older hypertensive humans; implications for arterial function." J Hypertens, 1998; 16: 423-8.
  7. Fletcher EC. "Can the treatment of sleep apnea prevent the cardiovascular consequences?" Sleep 1996; 19: S67-70.
  8. Schein M, Gavish B, Herz M et al. "Treating hyper-tension with a device that slows and regularizes breathing: a randomized double-blind controlled study." J Human Hypertens, 2001; 15(4):271-278.
  9. Grossman E, Grossman A, Schein MH et al. "Breathing control lowers blood pressure." J Human Hypertens, 2001; 15(4):263-269.
  10. Rosenthal T, Alter A, Peleg E, & Gavish B. "Device guided breathing exercises reduce blood pressure-ambulatory and home measurements." Am J Hypertension, 2001; 14:1:74-76.

InterCure, Inc.

214 Carnegie Center Suite 300

Princeton, NJ 08540

Direct Inquiries to:

Phone: 609-799-7599

Fax: 609-799-7690

Sales and Ordering:

Customer Support Center

(877) 988-9388



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