Pilot Study to Evaluate the Somnotouch Device to Quantify Spontaneous Baroreflex Sensitivity

University Hospital, Angers46 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

NON_RANDOMIZED

Purpose

BASIC_SCIENCE

Masking

NONE

Enrollment

Conditions

Healthy Heart Failure

Interventions

Eligibility

Sex: ALLMin age: 18 YearsMax age: 80 YearsHealthy volunteers:

Medical Language ↔ Plain English

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% Exclusion Criteria: * with pace maker * under law protection * not affiliated to the national health insurance * skin lesion or severe allergia

Outcomes

Primary Outcomes

Coefficient of correlation in baroreflex sensitivity measurements between SOMNOTOUCH and FINAPRES nova during the orthostatic test

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)

Time frame: Day one

Secondary Outcomes

Coefficient of correlation in baroreflex sensitivity measurements between day one and day two during the orthostatic test

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).

Time frame: Day two vs Day one

Duration of recordings in hours over 24 hours that allows the measurement of the spontaneous baroreflex sensitivity with the SOMNOTOUCH system

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.

Time frame: Day one (24 hours)

Difference in the baroreflex sensitivity between Day & Night

We will compare the baroreflex sensitivity between day and night in each group and between groups.