- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03292523
Work Productivity in Hyperventilation Syndrome (WHY)
April 28, 2022 updated by: University Hospital, Lille
Hyperventilation syndrome is associated with impaired quality of life.
The aim of the study is to assess the relationship between work productivity, including absenteeism and presenteeism, and the severity of hyperventilation syndrome
Study Overview
Study Type
Observational
Enrollment (Actual)
50
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
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Lille, France
- Hôpital Calmette,CHU
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (ADULT, OLDER_ADULT)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Sampling Method
Probability Sample
Study Population
patients with confirmed hyperventilation syndrome, virgin of any treatment.
Description
Inclusion Criteria:
- Holders of employment contracts for at least 8 days
- Diagnosis of hyperventilation syndrome confirmed by:
Compatible symptoms and at least two symptoms reproduced by the hyperventilation challenge test: Nijmegen's score> 23 ; Demonstration of alveolar hyperventilation ( Either on rest blood and / or at rest (PaCO2 at rest <36 mmHg and D (A-a) O2 normal; Either during the HV test (increased recovery time of the basic PETCO2 after voluntary hyperventilation (greater than 5 minutes)
Exclusion Criteria:
- Existence of another chronic pulmonary disease (asthma, bronchial dilation, COPD, diffuse interstitial pneumonia, neuromuscular pathology ...) or cardiac (rhythm disorder, ischemic heart disease ...) which can participate in dyspnea
- Psychiatric illness / psychotropic treatment
- Pregnancy
- Patient already included in a clinical research protocol involving new therapeutics may not be included in this protocol
- Specific physiotherapy or previous training
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
---|---|
Hyperventilation syndrome
|
Work Productivity and Activity Impairment (WPAI) Multidimensional Dyspnea Profile (MDP) Baseline Dyspnea Index (BDI), MOS-SF36, Hospital Anxiety Depression (HAD) Cognitive Failure Questionnaire (CFQ).
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Association between the WPAI score and the Nijmegen score
Time Frame: At the time of diagnosis (Baseline)
|
At the time of diagnosis (Baseline)
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Association between the WPAI score and dyspnea scales
Time Frame: At the time of diagnosis (Baseline)
|
At the time of diagnosis (Baseline)
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Association between the WPAI score and quality of life scores
Time Frame: At the time of diagnosis (Baseline)
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At the time of diagnosis (Baseline)
|
Association between the WPAI score and PaCO2
Time Frame: At the time of diagnosis (Baseline)
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At the time of diagnosis (Baseline)
|
Association between the WPAI score and the Cognitive Failure Questionnaire score
Time Frame: At the time of diagnosis (Baseline)
|
At the time of diagnosis (Baseline)
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Cécile Chenivesse, MD, University Hospital, Lille
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (ACTUAL)
February 6, 2018
Primary Completion (ACTUAL)
February 23, 2021
Study Completion (ACTUAL)
February 23, 2021
Study Registration Dates
First Submitted
September 21, 2017
First Submitted That Met QC Criteria
September 21, 2017
First Posted (ACTUAL)
September 25, 2017
Study Record Updates
Last Update Posted (ACTUAL)
April 29, 2022
Last Update Submitted That Met QC Criteria
April 28, 2022
Last Verified
April 1, 2022
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2016_68
- 2017-A01542-51 (OTHER: ID-RCB number, ANSM)
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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