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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

46 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-12-31

Study Completion Date

2018-12-31

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.

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Detailed Description

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Conditions

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Healthy Heart Failure

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

NONE

Study Groups

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Young Healthy Volunteers

We will evaluate in this group (18 - 40 y) the use of the SOMNOtouch system to quantify the spontaneous baroreflex sensitivity

Group Type OTHER

SOMNOtouch device (Somnomedics)

Intervention Type DEVICE

In each arm, we will evaluate the capacity of SOMNOtouch to measure the baroreflex sensitivity compared to Finapre Nova (reference)

Orthostatic test

Intervention Type PROCEDURE

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

Finapres Nova device (FMS system)

Intervention Type DEVICE

Old Healthy Volunteers

We will evaluate in this group (50 - 80 y) the use of the SOMNOtouch system to quantify the spontaneous baroreflex sensitivity

Group Type OTHER

SOMNOtouch device (Somnomedics)

Intervention Type DEVICE

In each arm, we will evaluate the capacity of SOMNOtouch to measure the baroreflex sensitivity compared to Finapre Nova (reference)

Orthostatic test

Intervention Type PROCEDURE

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

Finapres Nova device (FMS system)

Intervention Type DEVICE

Patients with heart failure

We will evaluate in this group (50 - 80 y + Heart failure) the use of the SOMNOtouch system to quantify the spontaneous baroreflex sensitivity

Group Type OTHER

SOMNOtouch device (Somnomedics)

Intervention Type DEVICE

In each arm, we will evaluate the capacity of SOMNOtouch to measure the baroreflex sensitivity compared to Finapre Nova (reference)

Orthostatic test

Intervention Type PROCEDURE

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

Finapres Nova device (FMS system)

Intervention Type DEVICE

Interventions

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SOMNOtouch device (Somnomedics)

In each arm, we will evaluate the capacity of SOMNOtouch to measure the baroreflex sensitivity compared to Finapre Nova (reference)

Intervention Type DEVICE

Orthostatic 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

Intervention Type PROCEDURE

Finapres Nova device (FMS system)

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

* good health
* normal ECG
* cardiac ejection fraction \> 50%

* clinically sable
* with sinusal heart rhythm
* without sign of neuropathy
* 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

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

Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes