Sleep-disordered Breathing and Neurocognitive Assessment in Children and Young Adults
NCT ID: NCT04971850
Last Updated: 2025-09-15
Study Results
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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RECRUITING
NA
1200 participants
INTERVENTIONAL
2022-02-02
2028-02-29
Brief Summary
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The primary objective of the study is to determine whether psychological and neuropsychological test scores correlate with diagnostic PSG results.
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Detailed Description
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In addition, the clinical impact of SDB and the benefit of treatment are still not clear in children and young adults, including neurocognitive and developmental perspective.
Finally, the validation of simplified tools could optimize and simplify the detection of SDB in children and young adults.
Patients scheduled to perform a diagnostic PSG for routine clinical care will have additional recordings and questionnaires as part of the study.
The primary objective of the study is to determine whether psychological and neuropsychological test scores correlate with diagnostic PSG results.
Conditions
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Study Design
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NA
SINGLE_GROUP
DIAGNOSTIC
NONE
Study Groups
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Sleep-disordered breathing (SDB)
Patients aged 1 to 20 years old with a suspicion of SDB or a high-risk of SDB due to their pathology and hospitalized at Necker Hospital for a sleep study for their clinical care.
Sleep study
Procedures added by research during PSG :
* SDB screening questionnaires
* Electromyography (EMG) of accessory and abdominal muscles
* Cerebral oxygenation
* Mandibular movements
* Sleep headband (pre-teens and teens) or other connected device
* Automatic PSG analyzes
* Psychological and neuropsychological assessment The recordings of the study will be repeated at one year if the patient needs a treatment (surgery or noninvasive ventilation) following the results of the PSG.
Interventions
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Sleep study
Procedures added by research during PSG :
* SDB screening questionnaires
* Electromyography (EMG) of accessory and abdominal muscles
* Cerebral oxygenation
* Mandibular movements
* Sleep headband (pre-teens and teens) or other connected device
* Automatic PSG analyzes
* Psychological and neuropsychological assessment The recordings of the study will be repeated at one year if the patient needs a treatment (surgery or noninvasive ventilation) following the results of the PSG.
Eligibility Criteria
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Inclusion Criteria
* Written informed consent
Exclusion Criteria
* Significant psychomotor retardation
* Cooperation not possible
* Significant agitation
* Acute condition and/or temporary drug treatments that may interfere with the results of PSG (upper or lower airway infection)
* Patient under guardianship/curatorship
1 Year
20 Years
ALL
No
Sponsors
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URC-CIC Paris Descartes Necker Cochin
OTHER
Assistance Publique - Hôpitaux de Paris
OTHER
Responsible Party
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Principal Investigators
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Brigitte Fauroux, MD, PhD
Role: PRINCIPAL_INVESTIGATOR
Assistance Publique - Hôpitaux de Paris
Sonia Khirani, PhD
Role: STUDY_DIRECTOR
Assistance Publique - Hôpitaux de Paris
Locations
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Hôpital Necker-Enfants Malades
Paris, , France
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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2020-A03083-36
Identifier Type: OTHER
Identifier Source: secondary_id
APHP210042
Identifier Type: -
Identifier Source: org_study_id
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