MORE ON RESPERATE TECHNOLOGY
   CLINICAL INTRODUCTION
   CLINICAL TRIALS
   STUDY DESIGN
   RECENT PAPERS & PRESENTATIONS
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Clinical Trial Findings

Six separate clinical studies performed in 12 outpatient and family clinics in the US, Italy and Israel: four double-blinded, randomized, controlled [1-2,5]; one non-randomized controlled[4]; one open design [3].

The results of these trials, submitted and cleared by the FDA are as follows:

• Sustained blood pressure reductions achieved within the first 8 weeks of 15-minute daily treatment.
• No side effects.
• Greater reductions for older patients and patients with higher baseline blood pressure.
• Consistent results measured at the clinic, at home and with 24-hour ambulatory blood pressure monitoring.
• Dose-response relationship between the accumulated amount of RESPeRATE exercise and the resulting blood pressure reduction: 15 minutes of RESPeRATE exercise 3-4 times per week delivered significant reductions; additional minutes of exercise resulted in larger reductions.
  

Pooled Characteristics of Patient Population on Enrollment*

Number of patients		268
% Males		60%
Age (years):		57±11
Patients’ Age	<40	25%
	40-60	38%
	>60	37%
% Medicated		77%
# of meds	1 med	38%
	2 meds	38%
	>3 meds	24%
Systolic BP (mmHg)		150±14
Diastolic BP (mmHg)		90±9

* After excluding 21 drop outs and 46 patients who did not use the device as directed

• Patients’ ability to operate the RESPeRATE device without prior training and to comply with routine use were established objectively using the device’s internal memory.
• Pooled Characteristics of Patient Population on Enrollment*
  

Table 2 - Pooled Results of Clinical Studies

* Control group: Relaxation treatment by alternative device (Walkman with relaxing music) [1-2], placebo intervention by home blood pressure monitor [5,6] and both [3].