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

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

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 Overview

• Status: Completed
• Conditions: Heart Failure; Healthy
• Intervention / Treatment: Device: SOMNOtouch device (Somnomedics); Procedure: Orthostatic test; Device: Finapres Nova device (FMS system)

• Study Type: Interventional
• Enrollment (Actual): 46
• Phase: Not Applicable

Contacts and Locations

Study Locations

• France
  • Maine Et Loire
    • Angers, Maine Et Loire, France, 49000
      • CHU d'Angers
    • Cholet, Maine Et Loire, France, 49325
      • CH de Cholet

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

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

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: Young Healthy Volunteers; 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); In each arm, we will evaluate the capacity of SOMNOtouch to measure the baroreflex sensitivity compared to Finapre Nova (reference); Procedure: 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; Device: Finapres Nova device (FMS system)
Other: Old Healthy Volunteers; 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); In each arm, we will evaluate the capacity of SOMNOtouch to measure the baroreflex sensitivity compared to Finapre Nova (reference); Procedure: 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; Device: Finapres Nova device (FMS system)
Other: 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	Device: SOMNOtouch device (Somnomedics); In each arm, we will evaluate the capacity of SOMNOtouch to measure the baroreflex sensitivity compared to Finapre Nova (reference); Procedure: 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; Device: Finapres Nova device (FMS system)

What is the study measuring?

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)

Collaborators and Investigators

• Sponsor: University Hospital, Angers
• Collaborators: LivaNova; SomnoMedics

Study record dates

Study Major Dates

• Study Start: December 1, 2015
• Primary Completion (Actual): December 1, 2018
• Study Completion (Actual): December 1, 2018

Study Registration Dates

• First Submitted: December 21, 2015
• First Submitted That Met QC Criteria: January 7, 2016
• First Posted (Estimate): January 8, 2016

Study Record Updates

• Last Update Posted (Actual): January 7, 2020
• Last Update Submitted That Met QC Criteria: January 3, 2020
• Last Verified: January 1, 2020

More Information

Terms related to this study

• Keywords: Volunteers
• Additional Relevant MeSH Terms: Heart Diseases; Cardiovascular Diseases; Heart Failure
• Other Study ID Numbers: 15-A01215-44