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Design and Results
RESPeRATE has been
studied as an adjunctive treatment for hypertension in
six separate clinical trials [1-5] with over 250
patients. The results of all six clinical trials have
repeatedly demonstrated that the therapeutic breathing
exercises performed with RESPeRATE
provides a sustained blood pressure reduction, that is
both clinically meaningful and statistically
significant. Importantly, these reductions are in
addition to any reductions already achieved from the
patients’ medications.
The RESPeRATE clinical
studies were double-blinded, randomized, controlled
trials. In order to evaluate the net-effect of RESPeRATE
over relaxation techniques, patients in the control
group of the first three trials [1-2] received a Walkman
with relaxation cassettes. These trials demonstrated a
significant and sustained reduction in blood pressure
using RESPeRATE . Blood
pressure reductions in the control group did not achieve
the predetermined clinical threshold of 10 mmHg systolic
or 5 mmHg diastolic.
To further enhance the clinical credibility of RESPeRATE
,a fourth trial [3] using 24-hour ambulatory blood
pressure monitoring and a data-storing home blood
pressure monitor, was conducted and demonstrated similar
reductions. The fifth clinical trial, performed in one
of Italy's premier hypertension clinics in Monza [4],
demonstrated excellent patient compliance and
significant reduction in both home and office blood
pressure even in highly medicated patients.
RESPeRATE's most recent
study, a multi-center, double-blind, randomized,
controlled trial, was carried out in five centers in the
US [5]. The trial demonstrated the efficacy of RESPeRATE
without any prior training by a physician. The trial
also demonstrated a clear dose-response relationship
between the amount of RESPeRATE
exercise and the resulting blood pressure response. The
blood pressure reductions where greater as more exercise
was performed - appropriate and routine use of the
device for just 30 minutes a week resulted in
significant blood pressure reductions.
Trials of additional patient sub-populations, such as
diabetic hypertensives and patients resistant to
medication, are currently in progress.
The following additional documents are available for
download (information provided by manufacturer):
| Document Name
|
PDF Version |
|
| Clinical Information Brochure (5
pages) |
|
|
| Patient Education Brochure (6
pages) |
|
|
| White Paper on Treating
Hypertension (7 pages) |
|
|
References:
| [1] |
Schein M, Gavish B, Herz M
et al. "Treating hypertension with a device that
slows and regularizes breathing: a randomized
double-blind controlled study." J Human Hyperten
2001; 15(4): 271 - 278. |
| [2] |
Grossman E, Grossman A,
Schein MH, Zimlichman R, Gavish B "Breathing-control
lowers blood pressure." J Human Hyperten 2001;
15(4): 263 - 269. |
| [3] |
Rosenthal T, Alter A,
Peleg E, Gavish B. "Device-guided breathing
exercises reduce blood pressure and ambulatory and
home measurement." Am J Hyperten 2001; 14(1): 74 -
76. |
| [4] |
Giannattasio C, Failla M,
Meles E, Gentile G, Grappiolo A and Mancia G
“Efficacy of self treatment of hypertension at home
with device-guided breathing.” Am J Hyperten 2002;
15(4,2)186A. |
| [5] |
Elliott W, Izzo J, Rosing
D, Snyder C, White W, Alter A, Gavish B, and Black B
“Hypertension reduction by device-guided breathing
shows a dose-response relationship.” Am J Hyperten
2002; 15(4,2)186A. |
|
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