Pilot Study to Evaluate the Somnotouch Device to Quantify Spontaneous Baroreflex Sensitivity (SOMNO-BRS)
Primary Purpose
Healthy, Heart Failure
Status
Completed
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
SOMNOtouch device (Somnomedics)
Orthostatic test
Finapres Nova device (FMS system)
Sponsored by
About this trial
This is an interventional basic science trial for Healthy focused on measuring Volunteers
Eligibility 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
Sites / Locations
- CHU d'Angers
- CH de Cholet
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Other
Other
Other
Arm Label
Young Healthy Volunteers
Old Healthy Volunteers
Patients with heart failure
Arm Description
We will evaluate in this group (18 - 40 y) the use of the SOMNOtouch system to quantify the spontaneous baroreflex sensitivity
We will evaluate in this group (50 - 80 y) the use of the SOMNOtouch system to quantify the spontaneous baroreflex sensitivity
We will evaluate in this group (50 - 80 y + Heart failure) the use of the SOMNOtouch system to quantify the spontaneous baroreflex sensitivity
Outcomes
Primary Outcome Measures
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)
Secondary Outcome Measures
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).
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.
Difference in the baroreflex sensitivity between Day & Night
We will compare the baroreflex sensitivity between day and night in each group and between groups.
Full Information
NCT ID
NCT02650232
First Posted
December 21, 2015
Last Updated
January 3, 2020
Sponsor
University Hospital, Angers
Collaborators
LivaNova, SomnoMedics
1. Study Identification
Unique Protocol Identification Number
NCT02650232
Brief Title
Pilot Study to Evaluate the Somnotouch Device to Quantify Spontaneous Baroreflex Sensitivity
Acronym
SOMNO-BRS
Official Title
Pilot Study to Evaluate the Somnotouch Device to Quantify Spontaneous Baroreflex Sensitivity in Healthy Subjects and in Patients With Heart Failure
Study Type
Interventional
2. Study Status
Record Verification Date
January 2020
Overall Recruitment Status
Completed
Study Start Date
December 2015 (undefined)
Primary Completion Date
December 2018 (Actual)
Study Completion Date
December 2018 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University Hospital, Angers
Collaborators
LivaNova, SomnoMedics
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Healthy, Heart Failure
Keywords
Volunteers
7. Study Design
Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
46 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Young Healthy Volunteers
Arm Type
Other
Arm Description
We will evaluate in this group (18 - 40 y) the use of the SOMNOtouch system to quantify the spontaneous baroreflex sensitivity
Arm Title
Old Healthy Volunteers
Arm Type
Other
Arm Description
We will evaluate in this group (50 - 80 y) the use of the SOMNOtouch system to quantify the spontaneous baroreflex sensitivity
Arm Title
Patients with heart failure
Arm Type
Other
Arm Description
We will evaluate in this group (50 - 80 y + Heart failure) the use of the SOMNOtouch system to quantify the spontaneous baroreflex sensitivity
Intervention Type
Device
Intervention Name(s)
SOMNOtouch device (Somnomedics)
Intervention Description
In each arm, we will evaluate the capacity of SOMNOtouch to measure the baroreflex sensitivity compared to Finapre Nova (reference)
Intervention Type
Procedure
Intervention Name(s)
Orthostatic test
Intervention Description
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
Device
Intervention Name(s)
Finapres Nova device (FMS system)
Primary Outcome Measure Information:
Title
Coefficient of correlation in baroreflex sensitivity measurements between SOMNOTOUCH and FINAPRES nova during the orthostatic test
Description
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)
Time Frame
Day one
Secondary Outcome Measure Information:
Title
Coefficient of correlation in baroreflex sensitivity measurements between day one and day two during the orthostatic test
Description
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).
Time Frame
Day two vs Day one
Title
Duration of recordings in hours over 24 hours that allows the measurement of the spontaneous baroreflex sensitivity with the SOMNOTOUCH system
Description
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.
Time Frame
Day one (24 hours)
Title
Difference in the baroreflex sensitivity between Day & Night
Description
We will compare the baroreflex sensitivity between day and night in each group and between groups.
Time Frame
Day one (24 hours)
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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
Facility Information:
Facility Name
CHU d'Angers
City
Angers
State/Province
Maine Et Loire
ZIP/Postal Code
49000
Country
France
Facility Name
CH de Cholet
City
Cholet
State/Province
Maine Et Loire
ZIP/Postal Code
49325
Country
France
12. IPD Sharing Statement
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Pilot Study to Evaluate the Somnotouch Device to Quantify Spontaneous Baroreflex Sensitivity
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