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

Healthy Clinical Trial

— 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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02650232
• Other study ID #: 15-A01215-44
• Status: Completed
• Phase: N/A
• Start date: December 2015
• Est. completion date: December 2018

Study information

• Verified date: January 2020
• Source: University Hospital, Angers
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 46
• Est. completion date: December 2018
• Est. primary completion date: December 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Healthy
• Heart Failure

Intervention

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)

Locations

Country	Name	City	State
France	CHU d'Angers	Angers	Maine Et Loire
France	CH de Cholet	Cholet	Maine Et Loire

Sponsors (3)

Lead Sponsor	Collaborator
University Hospital, Angers	LivaNova, SomnoMedics

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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)
Secondary	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)