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Autonomic Nervous System and Sickle Cell Disease (DrepaSympa)

A

Assistance Publique - Hôpitaux de Paris

Status

Completed

Conditions

Heart Rate Variability (ANS Function)

Study type

Observational

Funder types

Other

Identifiers

NCT04062409
K170302

Details and patient eligibility

About

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.

Full 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

Enrollment

90 patients

Sex

All

Ages

6 to 16 years old

Volunteers

No Healthy Volunteers

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

Trial design

90 participants in 2 patient groups

Sickle cell patients
Asmathic patients

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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