Primary:1. To determine the effect of a device slowing breathing (Resperate©) on BP in patients with treated hypertension with moderate BP control.Secondary:2. To determine the effect of a device slowing breathing (Resperate©) on Quality of life (…
ID
Source
Brief title
Condition
- Other condition
Synonym
Health condition
Hypertensie
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Changes in office systolic blood pressure in the intervention group compared to
changes in the controlgroup.
Secondary outcome
Changes in office diastolic blood pressure in the intervention group compared
to changes in the controlgroup.
Changes in systolic and diastolic blood pressure as measured by the patient at
home in the intervention group compared to changes in the controlgroup.
Changes in Quality of Life in the intervention group compared to changes in the
controlgroup.
Background summary
It is suggested from results in literature that there is a direct baroreflex
link between breath rate and heart rate and systolic blood pressure
variability. Acute responses to slow and regular breathing are: 1. Increased
baroreflex sensitivity and heart rate variability, reduced blood pressure and
peripheral resistance. Previous studies, often without a (proper) control group
and/or often initiated by the manufacturer of the Resperate, found positive
results. Our previous study could not reproduce these results in patients with
hypertension and diabetes. Baroreflex sensitivity could be impaired as a result
of diabetes itself, and therefore this could be the reason for not finding a
beneficial influence of the Resperate on blood pressure. This, and the
necessity to study this independently from the manufacturer led to the
development of this study in patients with moderately controlled hypertension,
but without diabetes.
Study objective
Primary:
1. To determine the effect of a device slowing breathing (Resperate©) on BP in
patients with treated hypertension with moderate BP control.
Secondary:
2. To determine the effect of a device slowing breathing (Resperate©) on
Quality of life (QoL) in patients with treated hypertension with moderate BP
control.
Study design
randomised single blind.
Intervention
Resperate© is a device that helps to slow down breathing. This device can
measure the breathing patterns through a breathing sensor mounted on the upper
abdomen or chest. Furthermore, music-like sound patterns can be composed
similar to this breathing pattern, which the patient can hear through the
headphones of the Resperate©. By prolonging the expiration, which can be
voluntarily used by the user, the frequency of respiration can be slowed down
and become more stable (aim <10 breathings per minute).
Study burden and risks
The total amount of time needed for the 2 visits at the hospital is 60 minutes.
At home, the patients are requested to measure their blood pressure before and
after the intervention. This will all take about 20 minutes a day. There are no
risks for the patients participating in this study because of the intervention.
Dokter van Heesweg 2
8025 AB Zwolle
Nederland
Dokter van Heesweg 2
8025 AB Zwolle
Nederland
Listed location countries
Age
Inclusion criteria
Patients are required to meet the following criteria: over 18 years old, known hypertension with a systolic BP (SBP) between 130-170 mm Hg at the previous visit to the internal outpatient department and at the last visit to the internist (which is the same day as baseline measurement) and treated with one or more anti-hypertensive drugs, which have not been changed for the preceding three months. At baseline the SBP should be between 140-160 mm Hg, measured by the investigator.
Exclusion criteria
Patients with known diabetes, heart failure (NYHA III-IV) and/or patients with pulmonary disease (for example asthma, chronic obstructive pulmonary disease and pulmonary fibrosis) will be excluded by the discretion of the treating internist. Patients with insufficient knowledge of the Dutch language to understand the requirements of the study will be excluded too.
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| CCMO | NL20147.075.07 |