Skip to main content
OpenTrials
Completed

NCT Number: NCT02650232

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

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Healthy Cardiovascular Diseases Heart Diseases Heart Failure

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

CHU d'Angers, Angers, Maine Et Loire, France

Loading trial locations.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

SOMNOtouch device (Somnomedics)

Device

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

Orthostatic test

Procedure

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

Finapres Nova device (FMS system)

Device

Primary outcomes

  1. Coefficient of correlation in baroreflex sensitivity measurements between SOMNOTOUCH and FINAPRES nova during the orthostatic test

    Time frame: 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 outcomes

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

    Time frame: 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).

  2. Duration of recordings in hours over 24 hours that allows the measurement of the spontaneous baroreflex sensitivity with the SOMNOTOUCH system

    Time frame: 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.

  3. Difference in the baroreflex sensitivity between Day & Night

    Time frame: Day one (24 hours)

    We will compare the baroreflex sensitivity between day and night in each group and between groups.

Sponsors and collaborators

Lead sponsor

University Hospital, Angers

Other Gov

Collaborators

  • LivaNova
  • SomnoMedics

Registry information

Official study title

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

Acronym: SOMNO-BRS

Important dates

Study start
2015
Primary completion
2018
Study completion
2018
First posted
Jan 8, 2016
Registry last updated
Jan 7, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.