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

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

      • Paris, France, 75019
        • Robert Debre Hospital

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
Sickle cell patients
Asmathic patients

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
heart rate variability after salbutamol administration
cross-sectional, one hour

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

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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