Development of Tools for Respiration and Circulation Exploration

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.

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Key information

Conditions

Motor Activity Behavior

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

TIMC - pavillon Taillefer - CHU, Grenoble, France

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

healthy, major and socially insured human subjects

Exclusion criteria

deprived of liberty, hospitalized and protected human subjects

Treatment and study plan

a set of wearable respiration and cardiac monitoring devices

Device

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

Other names: Equivital® from Hidalgo Ltd UK,, VISURESP from RBI Instrumentation France,, Finometer® from Finapres Medical Systems NL

Primary outcomes

Feasibility and use of developed methods and tools in clinical or fundamental research protocols or in systems for physiological monitoring in humans

Time frame: up to 24 months

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.

Sponsors and collaborators

Lead sponsor

University Hospital, Grenoble

Other

Collaborators

Centre National de la Recherche Scientifique, France
Université Joseph Fourier

Registry information

Official study 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

Acronym: MAPO-RCVQ

Important dates

Study start: 2014
Primary completion: 2017
Study completion: 2017
First posted: Apr 15, 2014
Registry last updated: May 18, 2018

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.

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Completed