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Biomarkers in Dyspnea (BIODYSPNEE)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03056547
Recruitment Status : Completed
First Posted : February 17, 2017
Last Update Posted : September 13, 2019
Sponsor:
Information provided by (Responsible Party):
Association pour le Développement et l'Organisation de la Recherche en Pneumologie et sur le Sommeil

Study Description
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Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Healthy Volunteers Other: Induced dyspnea Not Applicable

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 Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 34 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Basic Science
Official Title: Biomarkers in Dyspnea
Actual Study Start Date : November 23, 2017
Actual Primary Completion Date : January 8, 2019
Actual Study Completion Date : January 8, 2019

Resource links provided by the National Library of Medicine


Arms and Interventions
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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").


Outcome Measures
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Primary Outcome Measures :
  1. Biomakers in dyspnea [ Time Frame: 60 minutes ]
    Biomarkers in human model of induced dyspnea


Secondary Outcome Measures :
  1. Correlation with dyspnea intensity [ Time Frame: 60 minutes ]
    Correlation between intensity of dyspnea and biomarkers

  2. Correlation with dyspnea type [ Time Frame: 60 minutes ]
    Correlation between type of dyspnea and biomarkers


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03056547


Locations
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France
Centre d'Investigation Clinique Paris Est - Groupe Hospitalier Pitié-Salpêtrière
Paris, France, 75013
Sponsors and Collaborators
Association pour le Développement et l'Organisation de la Recherche en Pneumologie et sur le Sommeil
More Information
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Responsible Party: Association pour le Développement et l'Organisation de la Recherche en Pneumologie et sur le Sommeil
ClinicalTrials.gov Identifier: NCT03056547    
Other Study ID Numbers: ADOREPS_5
First Posted: February 17, 2017    Key Record Dates
Last Update Posted: September 13, 2019
Last Verified: September 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Dyspnea
Respiration Disorders
Respiratory Tract Diseases
Signs and Symptoms, Respiratory