Development of Tools for Respiration and Circulation Exploration

NCT ID: NCT02114749

Last Updated: 2018-05-18

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

25 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-02-24

Study Completion Date

2017-12-13

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Motor Activity

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

NONE

Study Groups

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volunteers in daily life activities

a set of wearable respiration and cardiac monitoring devices

Group Type EXPERIMENTAL

a set of wearable respiration and cardiac monitoring devices

Intervention Type DEVICE

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

Interventions

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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

Intervention Type DEVICE

Other Intervention Names

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

Eligibility Criteria

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Inclusion Criteria

* healthy, major and socially insured human subjects

Exclusion Criteria

* deprived of liberty, hospitalized and protected human subjects
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Université Joseph Fourier

OTHER

Sponsor Role collaborator

Centre National de la Recherche Scientifique, France

OTHER

Sponsor Role collaborator

University Hospital, Grenoble

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Briot Raphaël, MD

Role: PRINCIPAL_INVESTIGATOR

University Hospital, Grenoble

Locations

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TIMC - pavillon Taillefer - CHU

Grenoble, , France

Site Status

University Hospital

Grenoble, , France

Site Status

Countries

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France

References

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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. doi: 10.1152/ajpregu.00792.2006. Epub 2007 Jan 11.

Reference Type BACKGROUND
PMID: 17218438 (View on PubMed)

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. doi: 10.1152/ajpheart.00655.2003. Epub 2004 Jan 29.

Reference Type BACKGROUND
PMID: 14751864 (View on PubMed)

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. doi: 10.1007/978-1-4615-1375-9_79. No abstract available.

Reference Type BACKGROUND
PMID: 11729931 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 18846561 (View on PubMed)

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

Reference Type BACKGROUND

Related Links

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http://www-timc.imag.fr/

web site laboratory Techniques de l'Ingénierie Médicale et de la Complexité - Informatique, Mathématiques et Applications, Grenoble (TIMC-IMAG)

Other Identifiers

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University Hospital, Grenoble

Identifier Type: -

Identifier Source: org_study_id

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