Moshe H Schein, MD1, Ariela Alter, PhD2, Simon Levine, MD3, Tuvia Baevsky, MD3, Alona Nessing, MD3, and Benjamin Gavish, PhD2. 1Family Medicine, Hadassah – Hebrew University Medical Center, Jerusalem, Israel, 2 InterCure Ltd, Lod, Israel and 3 Clalit Health Services, Tel-Aviv.

Objectives: To assess the efficacy of device-guided breathing in lowering high blood pressure (BP) in diabetics and explore the association between the BP reduction and parameters characterizing the use of the device.

Design and Methods: A randomized controlled study with non-insulin-dependent diabetics with uncontrolled BP (>130/80 mmHg), receiving anti-hypertensive therapy or unmedicated. Both treatment and control groups continued with their regular treatment, however the treatment group used in addition, a device (RESPeRATE, InterCure Ltd, Israel) that interactively guides the user towards slow and regular breathing with prolonged expiration. The device monitors and analyzes the user’s breathing rate and pattern and composes in real time musical tones. The user voluntarily synchronizes his breathing with the music, during 15 minute daily sessions at home for an 8-week period. Data automatically stored in the devices, providing minute-by-minute breathing-pattern details was downloaded and analyzed after termination. The primary outcome was the BP change, measured in the family practice clinic, from baseline to termination.

Results: Baseline characteristics of 66 patients (33 treatment and 33 controls), 41M/25F were: age 62±8 years (mean±SD); BMI 29±5 kg/m2; BP 148±11/81±9 mmHg; 82% received hypertension medication and 67% diabetic medication. BP was reduced in the treatment group, -10.1±1.8/-3.6±1.3 mmHg, mean±SE, (p<0.0001/p<0.01), but not in control +1.6±2.2/-1.0±1.4 mmHg, p>0.4/p>0.4), (p=0.0005/p=0.08 between groups). All patients in the treatment group were able to reduce breathing rate during the session to below10 breaths per minute, from 14.3±0.8 to 8.5±0.6 breaths/min (mean±SE, p<0.0001). There were highly individualized variations during the session (50% increase) in the ratio between inspiration and expiration times. Greater BP reduction, both systolic and diastolic, was observed with increased device usage (p<0.05/p<0.05). BP change of -16.6±2.9/-10.0±1.8 mmHg was observed in the high-usage tertile, who carried out more than 50 sessions during 8 weeks.

Conclusion: Self-treatment at home with interactive device-guided breathing for 8 weeks by non-insulin dependent diabetic patients was associated with a significant reduction in systolic office BP which was enhanced with increased device usage.