NCT03056547

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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
34

participants targeted

Target at P25-P50 for not_applicable healthy-volunteers

Timeline
Completed

Started Nov 2017

Typical duration for not_applicable healthy-volunteers

Geographic Reach
1 country

1 active site

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

First Submitted

Initial submission to the registry

February 15, 2017

Completed
2 days until next milestone

First Posted

Study publicly available on registry

February 17, 2017

Completed
9 months until next milestone

Study Start

First participant enrolled

November 23, 2017

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 8, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 8, 2019

Completed
Last Updated

September 13, 2019

Status Verified

September 1, 2019

Enrollment Period

1.1 years

First QC Date

February 15, 2017

Last Update Submit

September 12, 2019

Conditions

Healthy Volunteers

Outcome Measures

Primary Outcomes (1)

  • Biomakers in dyspnea

    Biomarkers in human model of induced dyspnea

    60 minutes

Secondary Outcomes (2)

  • Correlation with dyspnea intensity

    60 minutes

  • Correlation with dyspnea type

    60 minutes

Study Arms (1)

Induced dyspnea

EXPERIMENTAL
Other: Induced dyspnea

Interventions

Induced dyspneaOTHER

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

Induced dyspnea

Eligibility Criteria

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

You may qualify if:

  • healthy volunteers

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

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

Paris, 75013, France

Location

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

February 15, 2017

First Posted

February 17, 2017

Study Start

November 23, 2017

Primary Completion

January 8, 2019

Study Completion

January 8, 2019

Last Updated

September 13, 2019

Record last verified: 2019-09

Locations

FR(1)