NCT04971850 Sleep-disordered Breathing and Neurocognitive Assessment in Children and Young Adults
| NCT ID | NCT04971850 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Assistance Publique - Hôpitaux de Paris |
| Condition | Sleep-disordered Breathing (SDB) |
| Study Type | INTERVENTIONAL |
| Enrollment | 1,200 participants |
| Start Date | 2022-02-02 |
| Primary Completion | 2028-02 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 1,200 participants in total. It began in 2022-02-02 with a primary completion date of 2028-02.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
One of main problems in the management of sleep-disordered breathing (SDB) in children and young adults is their screening, and the absence or the weak correlation between clinical symptoms and polysomnography (PSG). It may be useful to use additional measures together with PSG to improve the detection and characterization of respiratory events during sleep and/or correlation with clinical signs of SDB. The primary objective of the study is to determine whether psychological and neuropsychological test scores correlate with diagnostic PSG results.
Eligibility Criteria
Inclusion Criteria: * Patients aged 1 to 20 years with a suspicion of SDB or a high-risk of SDB due to their pathology and hospitalized at Necker Hospital for a sleep study * Written informed consent Exclusion Criteria: * No social insurance * 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
Contact & Investigator
Brigitte Fauroux, MD, PhD
PRINCIPAL INVESTIGATOR
Assistance Publique - Hôpitaux de Paris
Frequently Asked Questions
Who can join the NCT04971850 clinical trial?
This trial is open to participants of all sexes, aged 1 Year or older, up to 20 Years, studying Sleep-disordered Breathing (SDB). Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT04971850 currently recruiting?
Yes, NCT04971850 is actively recruiting participants. Contact the research team at brigitte.fauroux@aphp.fr for enrollment information.
Where is the NCT04971850 trial being conducted?
This trial is being conducted at Paris, France.
Who is sponsoring the NCT04971850 clinical trial?
NCT04971850 is sponsored by Assistance Publique - Hôpitaux de Paris. The principal investigator is Brigitte Fauroux, MD, PhD at Assistance Publique - Hôpitaux de Paris. The trial plans to enroll 1,200 participants.