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Biomarkers in Dyspnea (BIODYSPNEE)

Primary Purpose

Healthy Volunteers

Status
Completed
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Induced dyspnea
Sponsored by
Association pour le Développement et l'Organisation de la Recherche en Pneumologie et sur le Sommeil
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional basic science trial for Healthy Volunteers

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

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

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Induced dyspnea

Arm Description

Outcomes

Primary Outcome Measures

Biomakers in dyspnea
Biomarkers in human model of induced dyspnea

Secondary Outcome Measures

Correlation with dyspnea intensity
Correlation between intensity of dyspnea and biomarkers
Correlation with dyspnea type
Correlation between type of dyspnea and biomarkers

Full Information

First Posted
February 15, 2017
Last Updated
September 12, 2019
Sponsor
Association pour le Développement et l'Organisation de la Recherche en Pneumologie et sur le Sommeil
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1. Study Identification

Unique Protocol Identification Number
NCT03056547
Brief Title
Biomarkers in Dyspnea
Acronym
BIODYSPNEE
Official Title
Biomarkers in Dyspnea
Study Type
Interventional

2. Study Status

Record Verification Date
September 2019
Overall Recruitment Status
Completed
Study Start Date
November 23, 2017 (Actual)
Primary Completion Date
January 8, 2019 (Actual)
Study Completion Date
January 8, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Association pour le Développement et l'Organisation de la Recherche en Pneumologie et sur le Sommeil

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

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.
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)

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Healthy Volunteers

7. Study Design

Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
34 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Induced dyspnea
Arm Type
Experimental
Intervention Type
Other
Intervention Name(s)
Induced dyspnea
Intervention Description
Biological samples will be assessed during and after breathing discomfort induced by laboratory models of dyspnea ("work/effort", "air hunger").
Primary Outcome Measure Information:
Title
Biomakers in dyspnea
Description
Biomarkers in human model of induced dyspnea
Time Frame
60 minutes
Secondary Outcome Measure Information:
Title
Correlation with dyspnea intensity
Description
Correlation between intensity of dyspnea and biomarkers
Time Frame
60 minutes
Title
Correlation with dyspnea type
Description
Correlation between type of dyspnea and biomarkers
Time Frame
60 minutes

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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
Facility Information:
Facility Name
Centre d'Investigation Clinique Paris Est - Groupe Hospitalier Pitié-Salpêtrière
City
Paris
ZIP/Postal Code
75013
Country
France

12. IPD Sharing Statement

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Biomarkers in Dyspnea

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