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NCT04624815 Clinical Trial

Factors Issued From Functional Exploration Associated to SAHOS in Asthmatic Children

Asthma Clinical Trial

— SASTHMA  

Official title:
Factors Issued From Functional Exploration Associated to SAHOS in Asthmatic Children

Clinical Trial Details — Status: Terminated

Administrative data
NCT number NCT04624815
Other study ID # APHP190828
Secondary ID IDRCB: 2019-A019
Status Terminated
Phase
First received
Last updated
Start date November 20, 2020
Est. completion date November 9, 2021

Study information
Verified date October 2020
Source Assistance Publique - Hôpitaux de Paris
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

There is an increase in the prevalence of obstructive apnea-hypopnea syndrome (OSA) in children for which the pathophysiological explanation is unknown. The main objective is to compare pharyngeal collapsibility in asthmatic children with SHS score > 2.75 or ≤ 2.75 (OSA prediction score validated in French). Secondary objectives: Compare pharyngeal size, tracheal size, loop gain and its components (controller, plant), lung volumes and expired and nasal NO in asthmatic children with SHS score > 2.75 or ≤ 2.75. The bias due to the possible existence of an alveolar hyperventilation syndrome associated with asthma will be taken into account.

Description:

Detailed measurements and questionnaires: Measurement of pharyngeal volume by acoustic pharyngometry in sitting and lying position with calculation of pharyngeal compliance. Measurement of ventilation (15 minutes) and transcutaneous PCO2 measurement, three apnea tests at the end of the test, hyperventilation test. PFT with spirometry and static volume measurement. Multiple flow measurement of exhaled NO with calculation of bronchial flow and alveolar fraction of NO. Nasal NO measurement. Questionnaires for OSA: the Pediatric Sleep Questionnaire (PSQ) and the SCR (Sleep Clinical Record). Questionnaires for functional respiratory disorder: French hyperventilation questionnaire SHAPE and the Nijmegen score

Recruitment information / eligibility
Status Terminated
Enrollment 6
Est. completion date November 9, 2021
Est. primary completion date November 9, 2021
Accepts healthy volunteers
Gender All
Age group 6 Years to 12 Years
Eligibility Inclusion Criteria: - Confirmed asthma established on the notion of typical respiratory functional signs and the notion of reversibility of a bronchial obstruction on previous PFT and/or asthma exacerbation diagnosed by the physician in an emergency room. Ongoing asthma treatment (including SABA on demand) Exclusion Criteria: - not asthmatic children

Study Design

Related Conditions & MeSH terms

Locations
Country Name City State
France Robert Debre Hospital Paris

Sponsors (1)
Lead Sponsor Collaborator
Assistance Publique - Hôpitaux de Paris

Country where clinical trial is conducted

France, 

Outcome
Type Measure Description Time frame Safety issue
Primary pharyngeal collapsibility pharyngeal collapsibility pharyngeal collapsibility Pharyngeal compliance will be measured using acoustic pharyngometry 1 year
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