NCT02114749

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
25

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Feb 2014

Longer than P75 for not_applicable

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 24, 2014

Completed
18 days until next milestone

First Submitted

Initial submission to the registry

March 14, 2014

Completed
1 month until next milestone

First Posted

Study publicly available on registry

April 15, 2014

Completed
3.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 13, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 13, 2017

Completed
Last Updated

May 18, 2018

Status Verified

May 1, 2018

Enrollment Period

3.8 years

First QC Date

March 14, 2014

Last Update Submit

May 15, 2018

Conditions

Motor Activity

Keywords

Healthy volunteersPhysiological variables : respiration and circulation

Outcome Measures

Primary Outcomes (1)

  • 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

Study Arms (1)

volunteers in daily life activities

EXPERIMENTAL

a set of wearable respiration and cardiac monitoring devices

Device: a set of wearable respiration and cardiac monitoring devices

Interventions

a set of wearable respiration and cardiac monitoring devicesDEVICE

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

Also known as: Equivital® from Hidalgo Ltd UK,, VISURESP from RBI Instrumentation France,, Finometer® from Finapres Medical Systems NL
volunteers in daily life activities

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • healthy, major and socially insured human subjects

You may not qualify if:

  • deprived of liberty, hospitalized and protected human subjects

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

TIMC - pavillon Taillefer - CHU

Grenoble, 38043, France

Location

University Hospital

Grenoble, 38043, France

Location

Related Publications (5)

  • 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.

    PMID: 17218438BACKGROUND

  • 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.

    PMID: 14751864BACKGROUND

  • 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.

    PMID: 11729931BACKGROUND

  • 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.

    PMID: 18846561BACKGROUND

  • 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

    BACKGROUND

Related Links

MeSH Terms

Conditions

Motor Activity

Condition Hierarchy (Ancestors)

Behavior

Study Officials

  • Briot Raphaël, MD

    University Hospital, Grenoble

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
BASIC SCIENCE
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 14, 2014

First Posted

April 15, 2014

Study Start

February 24, 2014

Primary Completion

December 13, 2017

Study Completion

December 13, 2017

Last Updated

May 18, 2018

Record last verified: 2018-05

Locations

FR(2)