NCT02650232

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

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 46 (actual)
• Sponsor: University Hospital, Angers · Other Government
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Accepted

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.

Conditions

• Healthy
• Heart Failure

Interventions

Type	Name	Description
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)

Timeline

• Start date: 2015-12-01
• Primary completion: 2018-12-01
• Completion: 2018-12-01
• First posted: 2016-01-08
• Last updated: 2020-01-07

Locations

2 sites across 1 country: France