Biomarkers in Dyspnea

Healthy Volunteers Clinical Trial

— BIODYSPNEE  

Official title:

Biomarkers in Dyspnea

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03056547
• Other study ID #: ADOREPS_5
• Status: Completed
• Phase: N/A
• Start date: November 23, 2017
• Est. completion date: January 8, 2019

Study information

• Verified date: September 2019
• Source: Association pour le Développement et l'Organisation de la Recherche en Pneumologie et sur le Sommeil
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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)

Recruitment information / eligibility

• Status: Completed
• Enrollment: 34
• Est. completion date: January 8, 2019
• Est. primary completion date: January 8, 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Dyspnea
• Healthy Volunteers

Intervention

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

Locations

Country	Name	City	State
France	Centre d'Investigation Clinique Paris Est - Groupe Hospitalier Pitié-Salpêtrière	Paris

Sponsors (1)

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

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Biomakers in dyspnea	Biomarkers in human model of induced dyspnea	60 minutes
Secondary	Correlation with dyspnea intensity	Correlation between intensity of dyspnea and biomarkers	60 minutes
Secondary	Correlation with dyspnea type	Correlation between type of dyspnea and biomarkers	60 minutes