Condition category
Mental and Behavioural Disorders
Date applied
23/03/2018
Date assigned
09/04/2018
Last edited
05/04/2018
Prospective/Retrospective
Prospectively registered
Overall trial status
Ongoing
Recruitment status
Recruiting

Plain English Summary

Background and study aims
Dyspnea (shortness of breath) is an unpleasant defining symptom in various diseases including respiratory, cardiac, cancer-related, neuromuscular and psychological disorders, and is highly common in the general population. It is frequently associated with low mood, severe suffering, limited quality of life, high socioeconomic costs and even increased mortality risk. The physical pathways of dyspnea are partly unknown. Inducing dyspnea in healthy subjects in a controlled, laboratory situation (experimental dyspnea) is a common approach to understand the mechanisms of dyspnea and to describe its impact on various bodily functions. Little attention has been paid to the possible unwanted psychological impact of experimental dyspnea in subjects participating in experiments. It is possible that subjects exposed to experimental dyspnea could experience acute suffering that would be out of proportion with the value of the scientific information sought for by the study (therefore questioning the ethical balance of the research). This risk does not seem to have been specifically assessed previously.
The present study aims to test whether healthy volunteers could develop psychological changes related to post-traumatic stress. If this is true, the study also aims to find out whether this situation can be predicted through certain personal characteristics.

Who can participate?
Healthy adult volunteers who already take part in a laboratory-induced dyspnea experiment.

What does the study involve?
Participants will fill in questionnaires just before, and just after the laboratory-induced dyspnea experiment, as well as an online questionnaire 4 weeks after the experiment to assess the presence of post-traumatic stress syndrome.

What are the possible benefits and risks of participating?
The protocol is based on the free participation of healthy subjects. The procedure used has no risk to physical health, and the purpose of this study is to determine whether there are possible psychological consequences.

Where is the study run from?
The study will be conducted at the physiopathology respiratory laboratory of the hospital Pitié-Salpêtrière (Paris, France)

When is the study starting and how long is it expected to run for?
Start date : 01/05/2018 for 3 years

Who is funding the study?
There is no funding for this study

Who is the main contact?
Sophie Lavault, PhD
sophie.lavault@aphp.fr

Trial website

Contact information

Type

Public

Primary contact

Miss Sophie Lavault

ORCID ID

Contact details

Service de Pneumologie et Réanimation médicale
GH Pitié-Salpêtrière
Paris
75013
France

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

PSYCHOPNEA

Study information

Scientific title

Psychological impact of experimental dyspnea in healthy subjects and its determinants

Acronym

PSYCHOPNEA

Study hypothesis

Healthy volunteers could develop a post-traumatic stress disorder after experimental dyspnea.

Ethics approval

Evaluation ongoing at the CPP Sud-Est III (France), submitted 21/03/2018

Study design

Longitudinal cohort study

Primary study design

Observational

Secondary study design

Cohort study

Trial setting

Hospitals

Trial type

Other

Patient information sheet

Not available in web format, please use the contact details below to request a patient information sheet.

Condition

Post-traumatic stress disorder induced by dyspnea

Intervention

Experimental induced dyspnea and questionnaires (mood and psychological aspects)
Observational study :
- duration of participation for a subject : 1 month
- duration of the study : 3 years
- each participant will experiment 2 types of induced dyspnea (2 visits are necessary).
Healthy volunteers who are participating in other studies involving experimental dyspnea (ethical approval already obtained) will complete some questionnaires before and after the experimental dyspnea to assess the psychological dimension of this kind of experimentation.

Intervention type

Other

Phase

Drug names

Primary outcome measure

Presence of post-traumatic stress disorder, assessed with the validated French version of the PCL-5 questionnaire (score >38), 4 weeks after the experiment.

Secondary outcome measures

1. Change in "state anxiety" (STAI A questionnaire) compared with baseline (online, 1 week and 4 weeks after the experiment)
2. Correlation between score using Peritraumatic Distress Inventory (PDI) and score using PCL-5, 4 weeks after the experiment

Overall trial start date

01/03/2018

Overall trial end date

14/04/2021

Reason abandoned (if study stopped)

Eligibility

Participant inclusion criteria

Aged 18 years or over

Participant type

Healthy volunteer

Age group

Adult

Gender

Both

Target number of participants

100

Participant exclusion criteria

1. Pregnant
2. Protected adult
3. Person deprived of liberty
4. Existing respiratory pathology
5. Existence of any chronic pathology identified and subject to treatment, including psychiatric disorders
6. Absence of affiliation to social security
7. Vulnerable

Recruitment start date

01/05/2018

Recruitment end date

14/03/2021

Locations

Countries of recruitment

France

Trial participating centre

Service de Pneumologie et Réanimation médicale, Hôpital Pitié-Salpêtrière
47-83, boulevard de l'hôpital
Paris
75013
France

Sponsor information

Organisation

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

Sponsor details

ADOREPS
Service de Pneumologie et Réanimation médicale
Bâtiment Montyon
2ème étage
GH Pitié-Salpêtrière
47-83
boulevard de l'hôpital
Paris
75013
France

Sponsor type

Other

Website

Funders

Funder type

Not defined

Funder name

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

Alternative name(s)

ADOREPS

Funding Body Type

private sector organisation

Funding Body Subtype

professional associations and societies

Location

France

Results and Publications

Publication and dissemination plan

Planned publication in a high-impact peer reviewed journal.

IPD sharing statement
The data sharing plans for the current study are unknown and will be made available at a later date.

Intention to publish date

14/04/2022

Participant level data

Not expected to be available

Basic results (scientific)

Publication list

Publication citations

Additional files

Editorial Notes