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Factors Issued From Functional Exploration Associated to SAHOS in Asthmatic Children

Factors Issued From Functional Exploration Associated to SAHOS in Asthmatic Children

Status
Terminated
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT04624815
Acronym
SASTHMA
Enrollment
6
Registered
2020-11-12
Start date
2020-11-20
Completion date
2021-11-09
Last updated
2022-04-25

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Asthma, Obstructive Sleep Apnea Syndrome

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

Interventions

None listed

Sponsors

Assistance Publique - Hôpitaux de Paris
Lead SponsorOTHER

Study design

Observational model
CASE_ONLY
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
6 Years to 12 Years

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

Design outcomes

Primary

MeasureTime frameDescription
pharyngeal collapsibility pharyngeal collapsibility pharyngeal collapsibility1 yearPharyngeal compliance will be measured using acoustic pharyngometry

Countries

France

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026