NCT04971850

Sleep-disordered Breathing and Neurocognitive Assessment in Children and Young Adults

Sleep-Disordered Breathing and Neurocognitive Assessment in Children and Young Adults

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 1,200 (estimated)
• Sponsor: Assistance Publique - Hôpitaux de Paris · Academic / Other
• Sex: All
• Age: 1 Year – 20 Years
• Healthy volunteers: Not accepted

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.

Detailed description

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. 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

• Sleep-disordered Breathing (SDB)

Interventions

Type	Name	Description
OTHER	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.

Timeline

• Start date: 2022-02-02
• Primary completion: 2028-02-01
• Completion: 2028-02-01
• First posted: 2021-07-22
• Last updated: 2026-04-03

Locations

1 site across 1 country: France