Factors Issued From Functional Exploration Associated to SAHOS in Asthmatic Children

NCT ID: NCT04624815

Last Updated: 2022-04-25

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Total Enrollment

6 participants

Study Classification

OBSERVATIONAL

Study Start Date

2020-11-20

Study Completion Date

2021-11-09

Brief Summary

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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

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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

Conditions

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Asthma Obstructive Sleep Apnea Syndrome

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

PROSPECTIVE

Eligibility Criteria

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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
Minimum Eligible Age

6 Years

Maximum Eligible Age

12 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Assistance Publique - Hôpitaux de Paris

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Christophe DELCLAUX, MD-PhD

Role: PRINCIPAL_INVESTIGATOR

Assistance Public Hôpitaux de Paris

Locations

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Robert Debre Hospital

Paris, , France

Site Status

Countries

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France

Other Identifiers

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IDRCB: 2019-A01976-51

Identifier Type: REGISTRY

Identifier Source: secondary_id

APHP190828

Identifier Type: -

Identifier Source: org_study_id

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