Biomarkers in Dyspnea (BIODYSPNEE)

September 12, 2019 updated by: Association pour le Développement et l'Organisation de la Recherche en Pneumologie et sur le Sommeil
To explore biological mechanisms in human model of induced dyspnea, in order to remove the source of dyspnoea, to modify cerebral impact and to allow the development of targeted therapies.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

The aim of the study will be to identify a specific biology and immunology associated with dyspnoea. It will open therapeutic possibilities through a better understanding of the mechanisms of dyspnea.

Healthy volunteers will underwent two types of dyspnea. The subjects will be first familiar with both types of dyspnea and dyspnea measurement scales. Different components of dyspnea will be measured.

Blood tests will be performed at different times (before dyspnea, during dyspnea, 60 and 90 min after dyspnea)

Study Type

Interventional

Enrollment (Actual)

34

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Paris, France, 75013
        • Centre d'Investigation Clinique Paris Est - Groupe Hospitalier Pitié-Salpêtrière

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • healthy volunteers

Exclusion Criteria:

  • pregnancy
  • ongoing pain
  • respiratory disease
  • high levels of depression, panic disorder, or other significant mental health problems
  • not fluent in french

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Basic Science
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Induced dyspnea
Other: Induced dyspnea
Biological samples will be assessed during and after breathing discomfort induced by laboratory models of dyspnea ("work/effort", "air hunger").

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Biomakers in dyspnea
Time Frame: 60 minutes
Biomarkers in human model of induced dyspnea
60 minutes

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Correlation with dyspnea intensity
Time Frame: 60 minutes
Correlation between intensity of dyspnea and biomarkers
60 minutes
Correlation with dyspnea type
Time Frame: 60 minutes
Correlation between type of dyspnea and biomarkers
60 minutes

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Association pour le Développement et l'Organisation de la Recherche en Pneumologie et sur le Sommeil

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 23, 2017

Primary Completion (Actual)

January 8, 2019

Study Completion (Actual)

January 8, 2019

Study Registration Dates

First Submitted

February 15, 2017

First Submitted That Met QC Criteria

February 16, 2017

First Posted (Actual)

February 17, 2017

Study Record Updates

Last Update Posted (Actual)

September 13, 2019

Last Update Submitted That Met QC Criteria

September 12, 2019

Last Verified

September 1, 2019

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ADOREPS_5

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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