NCT02650232

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
46

participants targeted

Target at P50-P75 for not_applicable healthy

Timeline
Completed

Started Dec 2015

Longer than P75 for not_applicable healthy

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 1, 2015

Completed
20 days until next milestone

First Submitted

Initial submission to the registry

December 21, 2015

Completed
18 days until next milestone

First Posted

Study publicly available on registry

January 8, 2016

Completed
2.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2018

Completed
Last Updated

January 7, 2020

Status Verified

January 1, 2020

Enrollment Period

3 years

First QC Date

December 21, 2015

Last Update Submit

January 3, 2020

Conditions

HealthyHeart Failure

Keywords

Volunteers

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (3)

  • Coefficient of correlation in baroreflex sensitivity measurements between day one and day two during the orthostatic test

    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

    Day one (24 hours)

  • Difference in the baroreflex sensitivity between Day & Night

    Day one (24 hours)

Study Arms (3)

Young Healthy Volunteers

OTHER

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)Procedure: Orthostatic testDevice: Finapres Nova device (FMS system)

Old Healthy Volunteers

OTHER

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)Procedure: Orthostatic testDevice: Finapres Nova device (FMS system)

Patients with heart failure

OTHER

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)Procedure: Orthostatic testDevice: Finapres Nova device (FMS system)

Interventions

SOMNOtouch device (Somnomedics)DEVICE

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

Old Healthy VolunteersPatients with heart failureYoung Healthy Volunteers
Orthostatic testPROCEDURE

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

Old Healthy VolunteersPatients with heart failureYoung Healthy Volunteers
Finapres Nova device (FMS system)DEVICE
Old Healthy VolunteersPatients with heart failureYoung Healthy Volunteers

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • with chronic disease or treatment
  • under law protection
  • not affiliated to the national health insurance
  • For patients with heart failure
  • clinically sable
  • with sinusal heart rhythm
  • without sign of neuropathy
  • cardiac ejection fraction \< 50%
  • with pace maker
  • under law protection
  • not affiliated to the national health insurance
  • skin lesion or severe allergia

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

CHU d'Angers

Angers, Maine Et Loire, 49000, France

Location

CH de Cholet

Cholet, Maine Et Loire, 49325, France

Location

MeSH Terms

Conditions

Heart Failure

Condition Hierarchy (Ancestors)

Heart DiseasesCardiovascular Diseases

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
BASIC SCIENCE
Intervention Model
PARALLEL
Sponsor Type
OTHER GOV
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 21, 2015

First Posted

January 8, 2016

Study Start

December 1, 2015

Primary Completion

December 1, 2018

Study Completion

December 1, 2018

Last Updated

January 7, 2020

Record last verified: 2020-01

Locations

FR(2)