Harnessing the Therapeutic Power of Breathing  To Lower Blood Pressure & Reduce Stress                   April 2006       ...
Agenda Overview Respiratory Pacing & the Physiological Mechanism of  Action Clinical Studies Highlights Professional P...
FDA-Cleared, Hypertension Treatment Device   Clinically proven therapeutic breathing device   Sustained blood pressure r...
RESPeRATE: FDA Indication for Use            RESPeRATE Indications for use (FDA k# 020399 OTC)             RESPeRATE Indic...
World-Renowned Scientific Advisory Board    Henry R. Black, M.D. – Executive Committee, American Heart     Association Co...
RESPeRATE: Featured By Leading Medical &General Publications                                    6
Respiratory Pacing &the Physiological Mechanism of Action
Paced Breathing is Traditionally Used ForMeditation and HealingIts health benefits are taken for granted to be associated ...
Therapeutic Possibilities (from literature)  THERAPEUTIC INTERACTIONS     DISEASE AND AFFECTED SYSTEMS                    ...
Therapeutic Breathing Pattern   Beneficial for Hypertension         Slow & deep breathing (<10 breaths/min)               ...
Principle of Interactively Guided Breathing by theRESPeRATE (RR) DeviceHeadphones – hear tones with which       Computeriz...
Typical RESPeRATE Session (from logged data)                       13 “slow breathing minutes”             15             ...
Interactive Respiratory-Pacing Technology         Headphones                                          RESPeRATE           ...
Accumulated Effects of Paced Breathingon the Cardiovascular System                     1. Breathing rate ↓                ...
Respiratory Pacing Increases Capillary Blood  Flow (Reduces Vasoconstriction) & HRV                                       ...
Clinical Studies Highlights
Clinical Trials Highlights 7 separate published clinical trials1-6 (over 280 patients), of which 4  were randomized, cont...
Patient PopulationTested in Medicated, Elderly & Difficult-to-Control Populations      Number of patients                 ...
Study Designs All included the same 8-week daily treatment with RESPeRATE         Study         Treatment           Contro...
Significant Blood Pressure Reductions                         Treatment                Control                         Sys...
BP Controlled in 46% Patients of Stage 1 & 28% of Stage 2 Who Used RR )Compared to Control: 4% of Stage 2 (p<0.005) and 34...
Benefit Maintained (Month 2 to Month 6) in   Compliant Patients                                                           ...
RR Eliminated Most of the “White Coat Effect”                                       P=0.002                               ...
All-Day Sustained High BP Reductions24h ABPM Monitoring                      Significant 24-hour reduction within 8 weeks ...
Bulk of Reduction Within 3-4 Weeks                                   0%                                                   ...
Dose Response Relationship: Slow Breathing   Time vs. SBP Reduction                   Non              (Change in Systolic...
Response to Treatment Increases With Age                          0                          -5        BP change          ...
Demonstration
What RR Can Tell About Its Use?                Feedback on breathing rate and compliance                                  ...
Client’s Role in “Treatment withRESPeRATE”?    15-min daily session    Quiet room, no other activities    Record displa...
RESPeRATE User Survey (2006)Performed in partnership with Ipsos- Vantis      Good compliance: 90% use on regular basis, 7...
RESPeRATE Professional Programs                       3 Programs to Suit Your Practice Needs: Professional Dispensing Pro...
Questions and Feedback                         33
“He Who Controls Breathing,Controls Health”                   Old Proverb                            34
AdditionalPhysiological overview                     35
Paced Breathing Inhibits Sympathetic Outflow ViaIncreased Lung Inflation* Chemoreflex                              VOLUME ...
RESPeRATE vs. Metronome                 RESPeRATE elicits greater modulation of Heart Rate and pulsatile                 m...
BP Reductions & Vasodilatation via Respiratory-Pacing           Respiratory-Pacing; 15 min daily sessions        Spontaneo...
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Resperation and Stress

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Resperation and Stress

  1. 1. Harnessing the Therapeutic Power of Breathing To Lower Blood Pressure & Reduce Stress April 2006 Judy Chodirker, MHSc Manager, Scientific Affairs
  2. 2. Agenda Overview Respiratory Pacing & the Physiological Mechanism of Action Clinical Studies Highlights Professional Programs Questions? Feedback? 2
  3. 3. FDA-Cleared, Hypertension Treatment Device Clinically proven therapeutic breathing device Sustained blood pressure reductions within 8 weeks No side effects, no drug interactions Seven clinical trials published in peer-reviewed journals Relaxing, pleasant and easy to use“We found that RESPeRATE was very helpful to manyof our patients who experience shallow breathing. Andpatients, some of whom don’t have high bloodpressure, say it simply helps them relax. We use it forpatients to take home as a means of reinforcing ourbiofeedback work with them.” Leonard Schwartzburd, PhD Clinical Psychologist & Director of the Clinical Institute of Behavioral Medicine Berkeley, California 3
  4. 4. RESPeRATE: FDA Indication for Use RESPeRATE Indications for use (FDA k# 020399 OTC) RESPeRATE Indications for use (FDA k# 020399 OTC) The RESPeRATE is intended for use as a relaxation treatment for the The RESPeRATE is intended for use as a relaxation treatment for the reduction of stress by leading the user through interactively guided and reduction of stress by leading the user through interactively guided and monitored breathing exercises. The device is indicated for use only as monitored breathing exercises. The device is indicated for use only as an adjunctive treatment for high blood pressure, together with other an adjunctive treatment for high blood pressure, together with other pharmacological and/or non-pharmacological interventions. pharmacological and/or non-pharmacological interventions. Specifically indicated for adjunctive treatment of hypertension & reduction of stress Can be safely used with pharmacological and/or non-pharmacological interventions Does not require a prescription Any changes in medication should be discussed with the doctor who prescribed them 4
  5. 5. World-Renowned Scientific Advisory Board  Henry R. Black, M.D. – Executive Committee, American Heart Association Council on High Blood Pressure Research  Jay N. Cohn, M.D. – Founder Heart Failure Society of America; Past President, American & International Societies of Hypertension  Joseph L. Izzo, MD. - Vice Chair Research, Department of Medicine, University of Buffalo; Editorial Board, American Journal of Hypertension (AJH) & Journal of Clinical Hypertension (JCH).  Ehud Grossman, M.D. – President, Israeli Society of Hypertension; Editorial board, Journal of Human Hypertension .  Giuseppe Mancia, M.D. - Past President, International & European Society of Hypertension  Thomas Pickering, M.D. – Past President, Society of Behavioral Medicine; Past Secretary, American Society of Hypertension; Author of Joint National Committee on Hypertension (JNC VI).  Michael Weber, M.D. – Immediate Past President, American Society of Hypertension; Past editor of the American Journal of Hypertension. 5
  6. 6. RESPeRATE: Featured By Leading Medical &General Publications 6
  7. 7. Respiratory Pacing &the Physiological Mechanism of Action
  8. 8. Paced Breathing is Traditionally Used ForMeditation and HealingIts health benefits are taken for granted to be associated witheliciting the “relaxation response” Slow & deep Relaxation breathing response Health Yoga, TM… benefits Evidence shows a direct effect 8
  9. 9. Therapeutic Possibilities (from literature) THERAPEUTIC INTERACTIONS DISEASE AND AFFECTED SYSTEMS Cardio CNS Pulmonary Vascular CNS Heart Failure Sleep Apnea Paced Hypertension Breathing Migraine COPDCardiovascular Pulmonary Asthma Insomnia Paced breathing modifies multi-system disorders Panic Disorders mainly via neural pathways Stress 9
  10. 10. Therapeutic Breathing Pattern Beneficial for Hypertension Slow & deep breathing (<10 breaths/min) Long exhalation Without effort On exhaling • Sympathetic Outflow ↓ • Vagal Outflow ↑ • Baroreflex sensitivity ↑ • Chemoreflex sensitivity ↓ 10
  11. 11. Principle of Interactively Guided Breathing by theRESPeRATE (RR) DeviceHeadphones – hear tones with which Computerized unit – detects inspiration &user SYNCHRONIZES breathing expiration times and generates guiding tones with slightly longer duration Breathing pattern modification 2 INhale EXhale 3 Breathing IN & EX 1 Pacing tonesRespiration sensor – detects breathingpattern via changes in belt tension 11
  12. 12. Typical RESPeRATE Session (from logged data) 13 “slow breathing minutes” 15 Longer exhalation Respiration rate Effortless breathing ((breaths/min 10 Compliance & performance Expiration automatically stored ( time (sec 5 Inspiration ( time (sec Compliance = Total min. spent in slow breathing Performance = Measures 0 0 5 10 15 for quality of use“Slow breathing” Minutes of exercise (< 10 /min) 12
  13. 13. Interactive Respiratory-Pacing Technology Headphones RESPeRATE 15 minutes analyzed your Few times a week breathing and composes prolonged inhale & exhale tones RESPeRATE computerized unit Respiration SensorYou synchronize yourbreathing toRESPeRATEguiding tones * Lowers BP up to 36/20 mmHg (top 10% reductions) 13 Average reductions for high BP 14/8 mmHg
  14. 14. Accumulated Effects of Paced Breathingon the Cardiovascular System 1. Breathing rate ↓ 2. Pulmonary stretch receptors activation ↑ 3. Sympathetic outflow ↓ 4. Microvascular tone ↓ 5. Total peripheral resistance ↓ 6. Blood Pressure ↓ 14
  15. 15. Respiratory Pacing Increases Capillary Blood Flow (Reduces Vasoconstriction) & HRV SPONTANEOUS GUIDEDRespiration rate 16-17 /min 5-6 /min Respiration signal PP Increased (mmHg) Heart Rate Variability HR (bpm) Increased Capillary Capillary Flow Blood Flow Time (sec) Time (sec)Parati G, Gavish B, Izzo JL, Hypertension Primer (2003) 15
  16. 16. Clinical Studies Highlights
  17. 17. Clinical Trials Highlights 7 separate published clinical trials1-6 (over 280 patients), of which 4 were randomized, controlled 1,2,5 Significant & sustained 14/8 mmHg average reduction for high blood pressure, independent of both gender and medication status Greater reductions for older patients (18/8 mmHg for age>65) Found effective for Refractory Hypertension6 and Isolated Systolic Hypertension5 Significant and consistent results measured at the clinic 1-6, at home2-6 and with a 24-hour ambulatory blood pressure monitor3 No observed side effects [1] Schein M et al, J Human Hyperten 2001; 15(4): 271 – 278 (Data pooled from first two studies) [2] Grossman E et al, J Human Hyperten 2001; 15(4): 263 - 269. [3] Rosenthal T et al, Am J Hyperten 2001; 14(1): 74 - 76. [4] Meles E et al, Am J Hyperten 2004; 17:370-74. [5] Elliott et al J clinical Hypertension 2004; 6(10): 553-559. [6] Reuven Viskoper et al, Am J 2003; Vol 16:484-487 [7] Parati et al, Hypertension Primer, 3rd edition, pp 118 17
  18. 18. Patient PopulationTested in Medicated, Elderly & Difficult-to-Control Populations Number of patients 286 % Males 55% Age (average) 58±11 <40 3% Age in Years (%) 40-60 57% >60 40% % Medicated 78% 1 med 34% # of meds 2 med 36% >3 meds 30% Systolic BP (mmHg) 150±13 Diastolic BP (mmHg) 90±9 18
  19. 19. Study Designs All included the same 8-week daily treatment with RESPeRATE Study Treatment Control Comments 1 RR Walkman +6 m no treat 2 RR Walkman +6 m no treat 3 RR +BPM Walkman +BPM  POOLED 4 RR + BPM - 24ABPM DATA 5 RR + BPM BPM +6 m with treat 6 RR +BPM BPM   7 RR +BPM -   8 RR -   Korean study 9 RR +usual care ** Usual care**   Hyp. Diabetics Double blind and randomized 19
  20. 20. Significant Blood Pressure Reductions Treatment  Control Sys Dia Sys Dia 0  Pooled from 7 studies - 13.7 -8.4 - 8.9 - 4.1 -4  Significant BP reduction BP vs. control.change(mmHg) -8  Independent of gender or medication -12 P=0.002  Greater response P=0.008 in patients age >65 y -16 -18/-8 vs -8/-3 mmHg  No side effectsElliott et al ESH 2004Uncontrolled: Sys >140, n=129; Dia >90, n=83 20
  21. 21. BP Controlled in 46% Patients of Stage 1 & 28% of Stage 2 Who Used RR )Compared to Control: 4% of Stage 2 (p<0.005) and 34% of Stage 1 (p<0.05 Before After 8 weeks 180 180 Stage 2 Stage 2 (Systolic BP (mmHg (Systolic BP (mmHg 160 160 Stage 1 Stage 1 140 140 Pre-HTN Pre-HTN 120 120 Normal Normal 100 100 50 60 70 80 90 100 110 50 60 70 80 90 100 110 (Diastolic BP (mmHg (Diastolic BP (mmHg)Each point represents an individual RR patient (n= 211 21
  22. 22. Benefit Maintained (Month 2 to Month 6) in Compliant Patients Slow breathing Office BP in mmHg minutes per week 150 95 80SBP DBP Requested 45 or more 60 140 90 40 130 85 20 120 80 0 0 2 4 6 2 4 6 # months Treatment monthN=13, mean ± SEMeles E et al. Data on file 22
  23. 23. RR Eliminated Most of the “White Coat Effect” P=0.002 P=0.02 30 Treatment  Control 20 Treatment  Control 15 ( g H mm 20% ↓ 40% ↓ ( 20 81%↓ 75%↓ ( g H mm ( 10 10 5 P B cil ot s∆i D P Bcil ot∆ y S a s 0 0 Base End Base End Base End Base End For office SBP>140 mmHg and home SBP<135 mmHg For office DBP> 90 mmHg and home DBP< 85 mmHg 23Elliott et al. Am J Hyperten, 2005, 18(5): 211A.           Baseline & end home BP are averaged over 10
  24. 24. All-Day Sustained High BP Reductions24h ABPM Monitoring Significant 24-hour reduction within 8 weeks of 15 min. RESPeRATE daily treatment 150 145 Before treatment 140Systolic 135 BP 130(mmHg) 125 120 After 8 wks 15 min 115 daily treatment 110 0 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23N=14; p<0.001 Hour* Am J Hyperten 2001; 14(1): 74 – 76 24
  25. 25. Bulk of Reduction Within 3-4 Weeks 0% Control 25% Home Systolic BP change 50% (% of 8 wk reduction) 75% 100% 0 1 2 3 4 5 6 7 8 N=66; p<0.001 Treatment week* Meles E et al, Am J Hyperten 2004; 17:370-74.  25
  26. 26. Dose Response Relationship: Slow Breathing Time vs. SBP Reduction Non (Change in Systolic BP (mmHg 0 Extensive use N=121 use Minimum p<0.01 3.8 - requested 16.8 - 5- 45 min/wk mmHg mmHg p<0.001 10- 15- 20- 0 25 50 75 100 125 (Average Slow Breathing time per week (minute* Elliott et al  J clinical Hypertension   June 2004 26
  27. 27. Response to Treatment Increases With Age 0 -5 BP change -2.2 (mmHg) -5.0 -10 -6.6 - 8.5 -11.4 -15 P<0.02 SBP for SBP -16.1 DBP -20 35-50 51-65 66-80 AGE (year)Elliott et al ESH 2004 27
  28. 28. Demonstration
  29. 29. What RR Can Tell About Its Use? Feedback on breathing rate and compliance To user Displays compliance upon turning ON # slow breathing minutes done in last 7 days Displayscompliance &performance - Goal: atPress STAT least 45 min. 29
  30. 30. Client’s Role in “Treatment withRESPeRATE”?  15-min daily session  Quiet room, no other activities  Record displayed “compliance” in a diary * (optional)  Monitor morning BP and record in a diary (optional)  Follow-up visits with healthcare professional as requested * The displayed compliance is very important for motivating the patient and to give a feeling of control/ self-empowerment. 30
  31. 31. RESPeRATE User Survey (2006)Performed in partnership with Ipsos- Vantis  Good compliance: 90% use on regular basis, 73% >2x/week (8-12 weeks from purchase)  Improved BP: 85% reported RESPeRATE improved their BP  Improved Sense of Well-being: 85% reported RESPeRATE had a positive impact on their general well being  Easy to Use: 95% reported RESPeRATE was easy to use or took just a few sessions to learn 31
  32. 32. RESPeRATE Professional Programs 3 Programs to Suit Your Practice Needs: Professional Dispensing Program  Take Control Sample Program  Value-added service for your clients.  Provides you with free* Sample  Enables you to dispense RR directly from your Certificates to enable your patients to clinic. experience RESPeRATE first-hand.  Use RR in your clinic, loan or sell to clients.  8-week trial period for enrolled patient  Fair compensation for your time – fully with option to purchase at end of trial controlled by you.  All shipping, billing and handling is looked  Recover initial cost of device within 2-3 clients after directly by InterCure (the developer  of RESPeRATE). RR accessories available to facilitate sharing of device * Not including shipping & handling charge of  Professional Coupon Program (NEW!) $39.95 – pass on a $50 discount to your patients 32
  33. 33. Questions and Feedback 33
  34. 34. “He Who Controls Breathing,Controls Health” Old Proverb 34
  35. 35. AdditionalPhysiological overview 35
  36. 36. Paced Breathing Inhibits Sympathetic Outflow ViaIncreased Lung Inflation* Chemoreflex VOLUME SIGNAL excluded CNS Cardiac Cardiac Stretch Output PHASIC Receptors Brain Stem Sympath. BLOOD LUNG Signal nervous PRESSURE VOLUME Processor Outflow Pulmonary Systemic CHANGE Stretch Vascular Receptors Resistance Sensory Arterial PRESSURE SIGNAL Inputs BaroreflexModified from Parati G, Gavish B, Izzo JL, Hypertension Primer (2003) 36
  37. 37. RESPeRATE vs. Metronome RESPeRATE elicits greater modulation of Heart Rate and pulsatile microvessel blood volume during exercise + vasodilatation effect post exercise Baseline ( Slow Breathing (6bpm Post Exercise 110 ( HR (bpm RESPeRATE 90 70 Metronome 50 Increased HR ) % ( ChangeBlood VolumeSkin Pulsatile 225 modulation RESPeRATE 175 Metronome 125 Metronome 75 RESPeRATE Increased 25 Vasodilatation 0 0.2 0.4 0.6 0.8 1 6.8 7.3 7.8 8.3 8.8 13 13.5 14 14.5 15 ( Exercise Time (min 37
  38. 38. BP Reductions & Vasodilatation via Respiratory-Pacing Respiratory-Pacing; 15 min daily sessions Spontaneous Respiration Paced Respiration Decreases Sympathetic Outflow Decreased TPR & Improved Baroreceptors SensitivityRegular 15 min. Conditioning Leads to Sustained BP Reductions 38

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