Assessing sleep-disordered breathing and cognitive function in children and young adults
Sleep-Disordered Breathing and Neurocognitive Assessment in Children and Young Adults
This study is trying to see if better tests for sleep problems in kids and young adults can help us understand how those problems affect their thinking and learning.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 1200 (estimated) |
| Ages | 1 Year to 20 Years |
| Sex | All |
| Sponsor | Assistance Publique - Hôpitaux de Paris Academic / other |
| Locations | 1 site (Paris) |
| Trial ID | NCT04971850 on ClinicalTrials.gov |
What this trial studies
This study aims to improve the screening and management of sleep-disordered breathing (SDB) in children and young adults by correlating psychological and neuropsychological test scores with results from polysomnography (PSG). Patients scheduled for a diagnostic PSG will undergo additional assessments and questionnaires to gather comprehensive data on their condition. The goal is to enhance the detection of SDB and understand its clinical impact on neurocognitive development. By validating simplified tools, the study seeks to optimize the identification of SDB in this population.
Who should consider this trial
Good fit: Ideal candidates are children and young adults aged 1 to 20 years who are suspected of having sleep-disordered breathing and are hospitalized for a sleep study.
Not a fit: Patients with significant psychomotor retardation, severe agitation, or acute conditions that may interfere with PSG results may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to better detection and management of sleep-disordered breathing, ultimately improving cognitive and developmental outcomes for affected children and young adults.
How similar studies have performed: While the approach of correlating psychological assessments with PSG results is innovative, similar studies have shown promise in enhancing the understanding of sleep disorders in pediatric populations.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Paris
- Hôpital Necker-Enfants Malades — Paris, France (Recruiting)
Study contacts
- Principal investigator: Brigitte Fauroux, MD, PhD — Assistance Publique - Hôpitaux de Paris
- Study coordinator: Brigitte Fauroux, MD, PhD
- Email: brigitte.fauroux@aphp.fr
- Phone: 1 71 19 60 92
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.