hypertension / high blood pressure
Conditions
Interventions
Intervention: One group receives treatment with a breathing device (Resperate©)
and the other group receives treatment with a *control* breathing device. The
latter device does not try to alter the
Sponsors
diabetes kennis centrum
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: Patients are required to meet the following criteria: known T2DM, 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 according to the method described below.
Exclusion criteria
Exclusion criteria: Patients with orthostatic hypotension, known heart failure (NYHA III-IV) and/or patients with pulmonary disease (for example asthma, chronic obstructive pulmonary disease and pulmonary fibrosis) will be excluded. Patients with insufficient knowledge of the Dutch language to understand the requirements of the study will be excluded. Additional criteria were hospitalization in the past 3 months, deafness, blindness and cognitive abilities deemed insufficient for operation of a study device
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main study parameters/endpoints: The effect of the breathing device on SBP is the main study parameter. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary endpoints include diastolic blood pressure (DBP). | — |
Countries
Netherlands
Outcome results
None listed