Healthy, Heart Failure
Conditions
Keywords
Volunteers
Brief summary
To measure the spontaneous baroreflex sensitivity in ambulatory patient, a device made for measuring blood pressure beat by beat and continuously, the SOMNOtouch system, could be a useful tool. The SOMNOtouch system has never been used to assess the sensitivity of the baroreflex. A good correlation for measuring the baroreflex sensitivity between the system SOMNOtouch and digital photoplethysmography as a reference method is expected but should be evaluated. The main purpuse is to evaluate the SOMNOtouch system to quantify the spontaneous baroreflex sensitivity in healthy young subjects, in elderly healthy subjects and in subjects with heart failure. We will also evaluate the feasibility of measuring the baroreflex sensitivity in ambulatory conditions for 24 hours, the variations in sensitivity of the baroreflex sensitivity between day and night, the reproducibility of orthostatic tolerance test.
Interventions
DEVICESOMNOtouch device (Somnomedics)
In each arm, we will evaluate the capacity of SOMNOtouch to measure the baroreflex sensitivity compared to Finapre Nova (reference)
PROCEDUREOrthostatic test
For each arm we will proceed to an orthostatic test day one and day two with : * 10 minutes in supine position * 10 minutes in sitting position * 5 minutes in standing position * 5 minutes in supine position
DEVICEFinapres Nova device (FMS system)
Sponsors
LivaNova
SomnoMedics
University Hospital, Angers
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
BASIC_SCIENCE
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
Yes
Inclusion criteria
For healthy volunteers Inclusion Criteria: * good health * normal ECG * cardiac ejection fraction \> 50%
Exclusion criteria
* with chronic disease or treatment * under law protection * not affiliated to the national health insurance For patients with heart failure Inclusion Criteria: * clinically sable * with sinusal heart rhythm * without sign of neuropathy * cardiac ejection fraction \< 50%
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Coefficient of correlation in baroreflex sensitivity measurements between SOMNOTOUCH and FINAPRES nova during the orthostatic test | Day one | baroreflex sensitivity is measured by comparison of the variations in heart rate and in blood pressure (baroreflexe slope method & fransfer function method). We will compare this baroreflex sensitivity obtained from SOMNOTOUCH measurement and from Finapres nova measurements (coefficient of correlation) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Coefficient of correlation in baroreflex sensitivity measurements between day one and day two during the orthostatic test | Day two vs Day one | baroreflex sensitivity is measured by comparison of the variations in heart rate and in blood pressure (baroreflex slope method & fransfer function method). We will compare this baroreflex sensitivity between the two active orthostatic tests (coefficient of correlation). |
| Duration of recordings in hours over 24 hours that allows the measurement of the spontaneous baroreflex sensitivity with the SOMNOTOUCH system | Day one (24 hours) | We will mesure over 24 hours the duration in hours when the measurement of the baroreflex sensitivity is possible taken in account the quality of the physiological signals. |
| Difference in the baroreflex sensitivity between Day & Night | Day one (24 hours) | We will compare the baroreflex sensitivity between day and night in each group and between groups. |
Countries
France
Outcome results
None listed