Sleep-Disordered Breathing in Children With Cerebral Palsy at Increased Risk of Respiratory Disorders
Condition(s) studied
Investigational drug(s) / intervention(s)
Polysomnography: Sleep studies (polysomnography and polygraphy) will be performed and reported according to current American Academy of Sleep Medicine guidelines
Study summary
Currently, there are few and qualitatively unsatisfactory epidemiological data on the prevalence of sleep-disordered breathing (SDB) in children with cerebral palsy (CP).
The investigators aim to conduct a multicentre retrospective study to assess the presence of SDB in children with CP undergoing sleep studies (polysomnography or polygraphy).
Eligibility
Primary outcome measure(s)
- Number of Participants with obstructive sleep apnea in the study group — The primary outcome measure refers to the first or only sleep study performed by participants in the time interval between January 2020 and December 2023.
According to the American Academy of Sleep Medicine (AASM), pediatric obstructive sleep apnea (OSA) is diagnosed and classified based on the Apnea-Hypopnea Index (AHI) in the sleep study (polysomnography or polygraphy), which quantifies the number of apnea and hypopnea events per hour of sleep. The sleep study is diagnosed: Normal if AHI \< 1 event per hour; Mild OSA if AHI is between 1 and 5 events per hour; Moderate OSA if AHI is between 5 and 10 events per hour and Severe OSA if AHI is greater than 10 events per hour.
Trial sites (9)
| Facility | City | Region | Status |
|---|---|---|---|
| Uoc Hospice Pediatrico - Azienda Ospedale-Universita' Padova | Padova | PD | |
| Uoc Pronto Soccorso Pediatrico Azienda Ospedale-Universita' Padova | Padova | PD | |
| Istituto Serafico Di Assisi | Assisi | PG | |
| Ospedale Pediatrico Bambino Gesu' | Roma | RM | |
| Azienda Sanitario-Universitaria Sant'Andrea | Roma | RM | |
| Ospedale Umberto I | Salerno | SA | |
| Irccs Materno Infantile Burlo Garofolo | Trieste | TS | |
| Universita' Degli Studi Dell'Insubria | Varese | VR | |
| Azienda Sanitario-Universitaria Federico Ii | Naples | Italy |
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
View NCT07077226 on ClinicalTrials.gov ↗ ← All trials in Italy