Autonomic Nervous System and Sickle Cell Disease

Completed

• Conditions: Heart Rate Variability (ANS Function)

• Registration Number: NCT04062409
• Lead Sponsor: Assistance Publique - Hôpitaux de Paris

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.

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 Timeline

• Study Start: 2018-01-05
• Primary Completion: 2019-04-15
• Study Completion: 2019-05-31
• Status Verified: 2019-08
• Study First Submitted: 2019-08-19
• Study First Submitted QC: 2019-08-19
• Study First Posted: 2019-08-20
• Last Update Submitted: 2023-02-01
• Last Update Posted: 2023-02-03

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 90

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
To assess the effect of salbutamol administration on ANS in these SCD children (with and without asthma) and in control asthmatics (without SCD)	cross-sectional, one hour	heart rate variability after salbutamol administration

Secondary Outcome Measures

Name	Time	Method
To assess ANS functions in patients with SCD receiving asthma treatment or not, as compared to asthmatic children without SCD matched for ethnicity	cross-sectional, one hour	baseline heart rate variability

Trial Locations

Locations (1)

Robert Debre Hospital; 🇫🇷 Paris, France