About this trial
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 criteria
This trial does not accept healthy volunteersQualifiers
Aged less than 18 at the time of the sleep study
A diagnosis of Cerebral palsy
Written informed consent
Underwent a sleep study at one of the centers participating in the study during the reporting period (January 2020-December 2023)
Disqualifiers
None
Trial population
The study population consists of children (0-17 years) with cerebral palsy who underwent a sleep study (polysomnography or polygraphy) at one of the Italian centers participating in the study during the period from January 2020 to December 2023
Trial design
Cohort
Retrospective
Treatments tested in this trial
Polysomnography
Diagnostic testSleep studies (polysomnography and polygraphy) will be performed and reported according to current American Academy of Sleep Medicine guidelines
Treatment groups
Trial outcomes
Primary outcomes
Number of Participants with obstructive sleep apnea in the study group
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.
Sponsors and contacts
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GUIDO CAMANNI
Lead sponsor
Istituto Serafico per sordomuti e per ciechi
Sponsor institution
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