Clinical Proof

Proven Efficacy in Hypertension

RESPeRATE safety and efficacy were demonstrated in 16 separate clinical studies published in peer-reviewed medical journals. It has been used by over 300,000 patients and doctors in the past 15 years with great success and no reports of adverse reactions.

The American Heart Association who reviewed all non-drug methods for lowering blood pressure ranked RESPeRATE clinical evidence as #1 after diet and exercise and recommends it explicitly. [1]

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The overall evidence from clinical trials and meta-analyses suggests that device-guided slow breathing [RESPeRATE] can significantly lower blood pressure. There are no known contraindications to the use of the device, and no adverse effects have been noted.”

American Heart Association Scientific Statement: Beyond Medications and Diet [1]

Clinical Studies Summary:

The clinical studies demonstrated that using RESPeRATE as directed resulted in:

• Significant and sustained reduction in blood pressure (BP) within 8 weeks demonstrated when measured at the office [2-18], at home [3-7, 9, 12-13, 17] and with 24-hour ABPM [4, 10, 19].

• 10/5 mmHg (weighted average) sustained office BP reduction in adults both with controlled and uncontrolled BP (weighted average from the 16 studies (chart 1) [2-18]. Patients population ranged from controlled patients to refractory hypertensives [5], included comorbidities as diabetes [9, 11, 17, 19,] and obstructive sleep apnea [14], in the US, Europe, Middle East, and the Far East.

• Data available from 10 studies [2-8,10-11] show greater BP reductions for:
• Older patients: 16/7 mmHg for >age 65
• Higher initial BP: 17/7 for systolic BP>160 mmHg
• More time spent in slow breathing (<10 breaths/min) [chart 3].
• BP reductions were independent of gender and medications

Charts showing significantly lower blood pressure

 

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Why RESPeRATE Works

RESPeRATE BP lowering effect is rationalized by an acute reduction of the sympathetic neural activity [18, 20, 21] and a sustained decrease in peripheral resistance and arterial stiffness  [15] (see scheme above [22]).

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Benefits beyond blood pressure

Independent researchers around the world have been using RESPeRATE to harness the cardiovascular and neurological benefits of slow breathing with prolonged exhalation.

Beyond the 16 clinical studies in hypertension, RESPeRATE was clinically demonstrated to beneficial in the following conditions:

• Lower neural sympathetic activity. 4 studies [3,4,20,33]

• Benefit heart-failure patients. 5 studies [4,22-24,32].

• Benefit COPD patients [25]

• Benefit PTSD patients.  [26, 33]

• Reduce, chronic stress [27]

• Reduce anxiety [28]

• Improve Insomnia [31]

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References:

[1] Brook RC et al. A Scientific Statement From the American Heart Association Beyond Medications and Diet: Alternative Approaches to Lowering Blood Pressure. Hypertension. 2013;61(6):1360-1383

[2] Cernes R, Zimlichman R. RESPeRATE: the role of paced breathing in hypertension treatment. J Am Soc Hypertens. 2015;9:38-47.

[3] Oneda B, Ortega KC, Gusmão JL, Araújo TG, Mion D Jr. Sympathetic nerve activity is decreased during device-guided slow breathing. Hypertens Res. 2010 Jul;33(7):708-712.

[4] Harada D, Asanoi H, Takagawa J, Ishise H, Ueno H, Oda Y et al. Slow and deep respiration suppresses steady-state sympathetic nerve activity in patients with chronic heart failure: from modeling to clinical application. American Journal of Physiology-Heart and Circulatory Physiology. 2014;307(8):H1159-H68

[5] Schein MH, Gavish B, Herz M, Rosner-Kahana D, Naveh P, Knishkowy B, Zlotnikov E, Ben-Zvi N, Melmed RN. Treating hypertension with a device that slows and regularises breathing: a randomised, double-blind controlled study. J Hum Hypertens. 2001;15:271-278.

[6] Grossman E, Grossman A, Schein MH, Zimlichman R, Gavish B. Breathing-control lowers blood pressure. J Hum Hypertens 2001;15:263–9.

[7] Rosenthal T, Alter A, Peleg E, Gavish B. Device guided breathing exercises reduce blood pressure: ambulatory and home measurements. Am J Hypertens 2001;14:74–76.

[8] Viskoper R, Shapira I, Priluck R, Mindlin R, Chornia L, Laszt A, et al. Nonpharmacologic treatment of resistant hypertensives by device-guided slow breathing exercises. Am J Hypertens 2003;16:484–487.

[9] Elliott WJ, Izzo JL Jr, White WB, Rosing DR, Snyder CS, Alter A, et al. Graded blood pressure reduction in hypertensive outpatients associated with use of a device to assist with slow breathing. J Clin Hypertens (Greenwich) 2004;6:553–559.

[10] Meles E, Giannattasio C, Failla M, Gentile G, Capra A, Mancia G. Nonpharmacologic treatment of hypertension by respiratory exercise in the home setting. Am J Hypertens 2004;17:370–4.

[11] Bae JH, Kim JH, Choe KH, Hong SP, Kim KS, Kim CH, Ko JK, Kim CH, Kim KS. Blood pressure change following 8-week, 15-minute daily treatment with paced breathing guided by a device: a Korean multi-center study. J Clin Hypertens 2006;8:79 [Korean with abstract in English in Korean Hyperten J 2006;1:19-23]

[12] Logtenberg SJ, Kleefstra N, Houweling ST, Groenier KH, Bilo HJ. Effect of device-guided breathing exercises on blood pressure in hypertensive patients with type 2 diabetes mellitus: a randomized controlled trial. J Hypertens 2007;25:241–6.

[13] Aydin L  et al, J Hyperten 2008; 26 (suppl 2): S371-S372.

[14] Schein MH, Gavish B, Baevsky T, Kaufman M, Levine S, Nessing A, et al. Treating hypertension in type II diabetic patients with device-guided breathing: a randomized controlled trial. J Hum Hypertens 2009; 23:325–331.

[15] Altena MR, Kleefstra N, Logtenberg SJ, Groenier KH, Houweling ST, Bilo HJ. Effect of device-guided breathing exercises on blood pressure in patients with hypertension: a randomized controlled trial. Blood Press 2009;18:273–9.

[16] Anderson DE, McNeely JD, Windham BG. Regular slow-breathing exercise effects on blood pressure and breathing patterns at rest. J Hum Hypertens 2010;24:807–813.

[17] Bertisch SM, Schomer A, Kelly EE, Baloa LA, Hueser LE, Pittman SD, et al. Device-guided paced respiration as an adjunctive therapy for hypertension in obstructive sleep apnea: a pilot feasibility study. Appl Psychophysiol Biofeedback 2011;36:173–179.

[18] Kim JH, Yoo BS, Lee SH, Yoon J, Choe KH, The Changes of Noninvasive Hemodynamic Parameters after Device-Guided Slow Breathing Exercise in Hypertensive Patients.  J Korean Soc Hypertens 2013;19:55-62

[19] KLandman GW, Drion I, van Hateren KJ, van Dijk PR, Logtenberg SJ, Lambert J, et al. Device-guided breathing as treatment for hypertension in type 2 diabetes mellitus: a randomized, double-blind, sham-controlled trial. JAMA Intern Med 2013;173:1346–1350.

[20] Hering D, Kucharska W, Kara T, Somers VK, Parati G, Narkiewicz K. Effects of acute and long-term slow breathing exercise on muscle sympathetic nerve activity in untreated male patients with hypertension. J Hypertens. 2013;31:739-746.

[21] Howorka K, Pumprla J, Tamm J, Schabmann A, Klomfar S, Kostineak E, et al. Effects of guided breathing on blood pressure and heart rate variability in hypertensive diabetic patients. Auton Neurosci 2013;179:131–137.

[22] Parati G, Malfatto G, Boarin S, Branzi G, Caldara G, Giglio A, Bilo G, Ongaro G, Alter A, Gavish B, Mancia G. Device-Guided Paced Breathing in the Home Setting. on Exercise Capacity, Pulmonary and Ventricular Function in Patients With Chronic Heart Failure: A Pilot Study. Circulation: Heart Failure. 2008;1:178-183

[23] Ekman I, Kjellström B, Falk K, Norman J, Swedberg K. Impact of device-guided slow breathing on symptoms of chronic heart failure: a randomized, controlled feasibility study. Eur J Heart Fail. 2011;13:1000-1005.

[24] Debicka-Dabrowska D, Lisi E, Drozdz T, Styczkiewicz K, Malfatto G, Salerno S, Bednarek A, Olszanecka A, Kielbasa G, Bilo G, Czarnecka, D, Kawecka-Jaszcz K, Parati G. Usefulness of slow breathing training in chronic heart failure. Study design and intermediate results. Journal of Hypertens 2015:33 e-Supplement1; e 462

[25] Borge CR, Mengshoel AM, Omenaas E, Mourn E,  Ekman I, Lein MP,  Mack U, Wahl AK,: Effects of guided deep breathing on breathlessness and the breathing pattern in chronic obstructive pulmonary disease: A double-blind randomized control study; Patient Education and Counseling 2015 ;98:182-190.

[26] de Jong MC, Boersma CH. Device-guided breathing as a possible tool to improve the outcome of exposure therapy.Mental Illness 2010;2:e6 [pp.25-27]

[27] Ouseph R, Calvin Croy C,Natvig C, Simoneau T, Laudenslager ML. Decreased mental health care utilization following a psychosocial intervention in caregivers of hematopoietic stem cell transplant patients. Mental Illness 2014; 6:5120 [pp. 9-13]

[28] Morarend QA, Spector ML, Dawson DV, Clark SH, Holmes DC. The use of a respiratory rate biofeedback device to reduce dental anxiety: an exploratory investigation. Appl Psychophysiol Biofeedback. 2011 Jun;36(2):63-70

[29] Morgenthaler T, Practice parameters for the psychological and behavioral treatment of insomnia: an update. An american academy of sleep medicine report. Sleep 2006;29:1415-9

[30] Bertisch SM, Use of relaxation techniques and complementary and alternative medicine by American adults with insomnia symptoms: results from a national survey. Journal of Clinical Sleep Medicine, Vol. 8, No. 6, 2012

[31] Huang AJ1, Phillips S, Schembri M, Vittinghoff E, Grady D. Device-guided slow-paced respiration for menopausal hot flushes: a randomized controlled trial. Obstet Gynecol. 2015;125:1130-1138

[32] Lachowska, K., Bellwon, J., Narkiewicz, K. et al. Long-term effects of device-guided slow breathing in stable heart failure patients with reduced ejection fraction. Clin Res Cardiol (2018)

[33] Ida T. Fonkoue, Acute effects of device-guided slow breathing on sympathetic nerve activity and baroreflex sensitivity in posttraumatic stress disorder. American Journal of Physiology Heart and Circulatory Physiology 315: H141–H149, 201

site updated by 2019/06/24
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