Pilot Study to Evaluate the Somnotouch Device to Quantify Spontaneous Baroreflex Sensitivity (SOMNO-BRS)

University Hospital, Angers

Status: Completed

Conditions: Healthy; Heart Failure

Treatments: Device: Finapres Nova device (FMS system); Procedure: Orthostatic test; Device: SOMNOtouch device (Somnomedics)

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT02650232

15-A01215-44

Details and patient eligibility

About

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.

Enrollment: 46 patients

Sex: All

Ages: 18 to 80 years old

Volunteers: Accepts Healthy Volunteers

Inclusion and exclusion 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%

Exclusion Criteria:

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

Trial design

Primary purpose: Basic Science

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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46 participants in 3 patient groups

Young Healthy Volunteers

Other group

Description:

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

Treatment:

Procedure: Orthostatic test

Device: SOMNOtouch device (Somnomedics)

Device: Finapres Nova device (FMS system)

Old Healthy Volunteers

Other group

Description:

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

Treatment:

Procedure: Orthostatic test

Device: SOMNOtouch device (Somnomedics)

Device: Finapres Nova device (FMS system)

Patients with heart failure

Other group

Description:

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

Treatment:

Procedure: Orthostatic test

Device: SOMNOtouch device (Somnomedics)

Device: Finapres Nova device (FMS system)