Development of Tools for Respiration and Circulation Exploration

Motor Activity Clinical Trial

— MAPO-RCVQ  

Official title:

Development of Tools for Respiration and Circulation Studies and Exploration, Their Mutual Interactions and the Functions Involved in the Daily Life in Healthy Volunteers

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02114749
• Other study ID #: University Hospital, Grenoble
• Status: Completed
• Phase: N/A
• Start date: February 24, 2014
• Est. completion date: December 13, 2017

Study information

• Verified date: May 2018
• Source: University Hospital, Grenoble
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This study is aimed to develop analysis methods and measurements tools for physiological variables : respiration, circulation and their mutual interactions and with the functions involved in the daily life in healthy volunteers (drinking, eating, sleeping, coughing...). The devices that are used are non invasive. The development of these tools needs to be validated on physiological signals obtained in healthy volunteers.

Description:

The analysis and interpretation of a record consist, for example, to measure the amplitude of the respiratory modulation of the cardiac period, a witness of the level of the subject's sympathetic activity.

To do this, a mathematical model of this oscillation is adjusted on the experimental data, and its characteristics (amplitude, phase, non-linearity...) are considered indexes of the interaction to be compared with the same characteristics in other conditions.

The transition to clinical applications requires validation of the developed tools on physiological signals recorded on healthy volunteers in a non-clinical environment, avoiding extra psychological stress in the Protocol followed.

Whether it is for the development of tools or their validation, it is essential that the sensors used are non-invasive.

Recorded situations are those of everyday life, such as working (only sedentary work are envisaged), eat, talk, rest and move from one place of life to another one.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 25
• Est. completion date: December 13, 2017
• Est. primary completion date: December 13, 2017
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• healthy, major and socially insured human subjects

Exclusion Criteria:

• deprived of liberty, hospitalized and protected human subjects

Related Conditions & MeSH terms

• Motor Activity

Intervention

Device:
• a set of wearable respiration and cardiac monitoring devices
feasibility of methods for detecting physiological state changes from a set of wearable respiration and cardiac monitoring devices

Locations

Country	Name	City	State
France	University Hospital	Grenoble
France	TIMC - pavillon Taillefer - CHU	GRENOBLE cedex 9

Sponsors (3)

Lead Sponsor	Collaborator
University Hospital, Grenoble	Centre National de la Recherche Scientifique, France, Université Joseph Fourier

Country where clinical trial is conducted

France, 

References & Publications (5)

Ben Lamine S, Calabrese P, Perrault H, Dinh TP, Eberhard A, Benchetrit G. Individual differences in respiratory sinus arrhythmia. Am J Physiol Heart Circ Physiol. 2004 Jun;286(6):H2305-12. Epub 2004 Jan 29. — View Citation

Eberhard A, Calabrese P, Baconnier P, Benchetrit G. Comparison between the respiratory inductance plethysmography signal derivative and the airflow signal. Adv Exp Med Biol. 2001;499:489-94. — View Citation

Emeriaud G, Eberhard A, Benchetrit G, Debillon T, Baconnier P. Calibration of respiratory inductance plethysmograph in preterm infants with different respiratory conditions. Pediatr Pulmonol. 2008 Nov;43(11):1135-1141. doi: 10.1002/ppul.20923. — View Citation

Fiamma MN, Straus C, Thibault S, Wysocki M, Baconnier P, Similowski T. Effects of hypercapnia and hypocapnia on ventilatory variability and the chaotic dynamics of ventilatory flow in humans. Am J Physiol Regul Integr Comp Physiol. 2007 May;292(5):R1985-93. Epub 2007 Jan 11. — View Citation

Fontecave-Jallon, Gumery P-Y, Calabrese P, Briot R, Baconnier P. A wearable technology revisited for cardio-respiratory functional exploration : Stroke volume estimation form respiratory inductive plethysmography. International journal of eHealth and Medical Communications, 4, 2013

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Feasibility and use of developed methods and tools in clinical or fundamental research protocols or in systems for physiological monitoring in humans	The new tools for identification and monitoring of the physiological state of a subject will be developed from a set of non-invasive measures at rest. Resulting physiological state identification will then be validated on registrations on the same subjects in different daily life circumstances.	up to 24 months

External Links

•   web site Centre d'Investigations Cliniques de Grenoble (CIC)
•   web site laboratory Techniques de l'Ingénierie Médicale et de la Complexité - Informatique, Mathématiques et Applications, Grenoble (TIMC-IMAG)