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OpenTrials
Completed

NCT Number: NCT04062409

Autonomic Nervous System and 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.

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Key information

Conditions

Heart Rate Variability (ANS Function) Anemia Anemia, Hemolytic Anemia, Hemolytic, Congenital Anemia, Sickle Cell Asthma Bronchial Diseases Congenital, Hereditary, and Neonatal Diseases and Abnormalities Genetic Diseases, Inborn Hematologic Diseases Hemic and Lymphatic Diseases Hemoglobinopathies Hypersensitivity Hypersensitivity, Immediate Immune System Diseases Lung Diseases Lung Diseases, Obstructive Respiratory Hypersensitivity Respiratory Tract Diseases

Age range

6 year–16 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Robert Debre Hospital

Paris, 75019, France

About this study

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

Who can participate

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

Assistance Publique - Hôpitaux de Paris

Other

Registry information

Official study title

Effect of Salbutamol on Autonomic Nervous System Dysfunction of Children With Sickle Cell Disease

Acronym: DrepaSympa

Important dates

Study start
2018
Primary completion
2019
Study completion
2019
First posted
Aug 20, 2019
Registry last updated
Feb 3, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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