- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04062409
Autonomic Nervous System and Sickle Cell Disease (DrepaSympa)
November 15, 2019 updated by: Assistance Publique - Hôpitaux de Paris
Effect of Salbutamol on Autonomic Nervous System Dysfunction of Children With Sickle Cell Disease
Sickle cell disease (SCD) children and adults with asthma have an increased rate of vaso-occlusive crisis, acute chest syndrome episodes, and premature mortality when compared to those without asthma.
We hypothesised that either asthma diagnosis and/or bronchodilator treatment may aggravate SCD via their modulating effect on autonomic nervous system.
Study Overview
Status
Completed
Conditions
Detailed Description
Heart rate variability during pulmonary function tests (spirometry, static volumes, DLCO/DLNO, exhaled NO at multiple flow rates) including salbutamol administration will be evaluated in patients with SCD (n=60) receiving asthma treatment or not, as compared to asthmatic children without SCD (n=30) matched for ethnicity
Study Type
Observational
Enrollment (Actual)
90
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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Paris, France, 75019
- Robert Debre Hospital
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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
6 years to 16 years (Child)
Accepts Healthy Volunteers
N/A
Genders Eligible for Study
All
Sampling Method
Non-Probability Sample
Study Population
Subjects of African or Caribbean ethnicity who were 8 to 16 years of age and were referred to the Pulmonary function Testing unit for the follow-up of their disease : SCD or asthma
Description
Inclusion Criteria:
- age from 8 to 16 years (≥ 8 years and < 16 years) (spirometry and DLCO study feasible)
- Sub-Saharan African or Caribbean ethnic origin.
- child with sickle cell disease referred for monitoring of respiratory function in the framework of its sickle cell disease and whether or not it presents a possible disease asthmatic (asthma treatment prescribed in the past year)
- or asthmatic child (typical functional signs + history of exacerbation severe hospitalized or reversible obstructive pulmonary disorder) not sickle cell
- addressed for respiratory function monitoring
Exclusion Criteria:
- Refusal to participate (lack of consent)
- Sickle cell child of North African origin
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
- Observational Models: Case-Control
- Time Perspectives: Prospective
Cohorts and Interventions
Group / Cohort |
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Sickle cell patients
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Asmathic patients
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
To assess the effect of salbutamol administration on ANS in these SCD children (with and without asthma) and in control asthmatics (without SCD)
Time Frame: cross-sectional, one hour
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heart rate variability after salbutamol administration
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cross-sectional, one hour
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
To assess ANS functions in patients with SCD receiving asthma treatment or not, as compared to asthmatic children without SCD matched for ethnicity
Time Frame: cross-sectional, one hour
|
baseline heart rate variability
|
cross-sectional, one hour
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Principal Investigator: Christophe Delclaux, MD PhD, APHP
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
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)
January 5, 2018
Primary Completion (Actual)
April 15, 2019
Study Completion (Actual)
May 31, 2019
Study Registration Dates
First Submitted
August 19, 2019
First Submitted That Met QC Criteria
August 19, 2019
First Posted (Actual)
August 20, 2019
Study Record Updates
Last Update Posted (Actual)
November 18, 2019
Last Update Submitted That Met QC Criteria
November 15, 2019
Last Verified
August 1, 2019
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- K170302
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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