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

Not Applicable

Completed

• Conditions: Heart Failure; Healthy
• Interventions: Device: SOMNOtouch device (Somnomedics); Procedure: Orthostatic test; Device: Finapres Nova device (FMS system)

• Registration Number: NCT02650232
• Lead Sponsor: University Hospital, Angers

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2015-12
• Study First Submitted: 2015-12-21
• Study First Submitted QC: 2016-01-07
• Study First Posted: 2016-01-08
• Primary Completion: 2018-12
• Study Completion: 2018-12
• Status Verified: 2020-01
• Last Update Submitted: 2020-01-03
• Last Update Posted: 2020-01-07

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 46

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Young Healthy Volunteers	Orthostatic test	We will evaluate in this group (18 - 40 y) the use of the SOMNOtouch system to quantify the spontaneous baroreflex sensitivity
Young Healthy Volunteers	Finapres Nova device (FMS system)	We will evaluate in this group (18 - 40 y) the use of the SOMNOtouch system to quantify the spontaneous baroreflex sensitivity
Patients with heart failure	SOMNOtouch device (Somnomedics)	We will evaluate in this group (50 - 80 y + Heart failure) the use of the SOMNOtouch system to quantify the spontaneous baroreflex sensitivity
Patients with heart failure	Orthostatic test	We will evaluate in this group (50 - 80 y + Heart failure) the use of the SOMNOtouch system to quantify the spontaneous baroreflex sensitivity
Old Healthy Volunteers	SOMNOtouch device (Somnomedics)	We will evaluate in this group (50 - 80 y) the use of the SOMNOtouch system to quantify the spontaneous baroreflex sensitivity
Young Healthy Volunteers	SOMNOtouch device (Somnomedics)	We will evaluate in this group (18 - 40 y) the use of the SOMNOtouch system to quantify the spontaneous baroreflex sensitivity
Old Healthy Volunteers	Orthostatic test	We will evaluate in this group (50 - 80 y) the use of the SOMNOtouch system to quantify the spontaneous baroreflex sensitivity
Old Healthy Volunteers	Finapres Nova device (FMS system)	We will evaluate in this group (50 - 80 y) the use of the SOMNOtouch system to quantify the spontaneous baroreflex sensitivity
Patients with heart failure	Finapres Nova device (FMS system)	We will evaluate in this group (50 - 80 y + Heart failure) the use of the SOMNOtouch system to quantify the spontaneous baroreflex sensitivity

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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.
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).
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.

Trial Locations

Locations (2)

CHU d'Angers; 🇫🇷 Angers, Maine Et Loire, France

CH de Cholet; 🇫🇷 Cholet, Maine Et Loire, France