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

Study Overview
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Brief Summary
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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.

Official Title
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Pilot Study to Evaluate the Somnotouch Device to Quantify Spontaneous Baroreflex Sensitivity in Healthy Subjects and in Patients With Heart Failure

Conditions
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Healthy, Heart Failure

Intervention / Treatment
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* Device: SOMNOtouch device (Somnomedics)
* Procedure: Orthostatic test
* Device: Finapres Nova device (FMS system)


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Basic Science
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Young Healthy Volunteers<br>We will evaluate in this group (18 - 40 y) the use of the SOMNOtouch system to quantify the spontaneous baroreflex sensitivity | Device: SOMNOtouch device (Somnomedics)<br>* In each arm, we will evaluate the capacity of SOMNOtouch to measure the baroreflex sensitivity compared to Finapre Nova (reference)<br>Procedure: Orthostatic test<br>* 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<br>Device: Finapres Nova device (FMS system)<br> <br> |
| Other: Old Healthy Volunteers<br>We will evaluate in this group (50 - 80 y) the use of the SOMNOtouch system to quantify the spontaneous baroreflex sensitivity | Device: SOMNOtouch device (Somnomedics)<br>* In each arm, we will evaluate the capacity of SOMNOtouch to measure the baroreflex sensitivity compared to Finapre Nova (reference)<br>Procedure: Orthostatic test<br>* 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<br>Device: Finapres Nova device (FMS system)<br> <br> |
| Other: Patients with heart failure<br>We will evaluate in this group (50 - 80 y + Heart failure) the use of the SOMNOtouch system to quantify the spontaneous baroreflex sensitivity | Device: SOMNOtouch device (Somnomedics)<br>* In each arm, we will evaluate the capacity of SOMNOtouch to measure the baroreflex sensitivity compared to Finapre Nova (reference)<br>Procedure: Orthostatic test<br>* 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<br>Device: Finapres Nova device (FMS system)<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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) | Day one | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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). | 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. | 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. | Day one (24 hours) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Volunteers