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Autonomic Nervous System and Sickle Cell Disease (DrepaSympa)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04062409
Recruitment Status : Completed
First Posted : August 20, 2019
Last Update Posted : February 3, 2023
Sponsor:
Information provided by (Responsible Party):
Assistance Publique - Hôpitaux de Paris

Study Description
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Brief Summary:
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.

Condition or disease
Heart Rate Variability (ANS Function)

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 Design
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Study Type : Observational
Actual Enrollment : 90 participants
Observational Model: Case-Control
Time Perspective: Prospective
Official Title: Effect of Salbutamol on Autonomic Nervous System Dysfunction of Children With Sickle Cell Disease
Actual Study Start Date : January 5, 2018
Actual Primary Completion Date : April 15, 2019
Actual Study Completion Date : May 31, 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Asthma

Groups and Cohorts
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Group/Cohort
Sickle cell patients
Asmathic patients


Outcome Measures
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Primary Outcome Measures :
  1. 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 ]
    heart rate variability after salbutamol administration


Secondary Outcome Measures :
  1. 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


Eligibility Criteria
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Ages Eligible for Study:   6 Years to 16 Years   (Child)
Sexes 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
Criteria

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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04062409


Locations
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France
Robert Debre Hospital
Paris, France, 75019
Sponsors and Collaborators
Assistance Publique - Hôpitaux de Paris
Investigators
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Principal Investigator: Christophe Delclaux, MD PhD APHP
More Information
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Publications of Results:

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Responsible Party: Assistance Publique - Hôpitaux de Paris
ClinicalTrials.gov Identifier: NCT04062409    
Other Study ID Numbers: K170302
First Posted: August 20, 2019    Key Record Dates
Last Update Posted: February 3, 2023
Last Verified: August 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Assistance Publique - Hôpitaux de Paris:
sickle cell disease; asthma; beta-agonist; hear rate variability
Additional relevant MeSH terms:
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Anemia, Sickle Cell
Anemia, Hemolytic, Congenital
Anemia, Hemolytic
Anemia
 Hematologic Diseases
Hemoglobinopathies
Genetic Diseases, Inborn