Factors Issued From Functional Exploration Associated to SAHOS in Asthmatic Children

Terminated

• Conditions: Asthma; Obstructive Sleep Apnea Syndrome

• Registration Number: NCT04624815
• Lead Sponsor: Assistance Publique - Hôpitaux de Paris

Brief 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.

Detailed 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

Study Timeline

• Status Verified: 2020-10
• Study First Submitted: 2020-10-15
• Study First Submitted QC: 2020-11-05
• Study First Posted: 2020-11-12
• Study Start: 2020-11-20
• Primary Completion: 2021-11-09
• Study Completion: 2021-11-09
• Last Update Submitted: 2022-04-15
• Last Update Posted: 2022-04-25

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 6

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

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
pharyngeal collapsibility pharyngeal collapsibility pharyngeal collapsibility	1 year	Pharyngeal compliance will be measured using acoustic pharyngometry

Trial Locations

Locations (1)

Robert Debre Hospital; 🇫🇷 Paris, France