Ireland
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Starting soon Observational

Sleep-Disordered Breathing in Children With Cerebral Palsy at Increased Risk of Respiratory Disorders

NCT07077226 · tracked via the Priya Life Science Italy tracker
Sponsor
GUIDO CAMANNI
Phase
Observational
Started
2025-09-15
Last updated
2025-07-28

Condition(s) studied

Sleep-disordered Breathing (SDB)

Investigational drug(s) / intervention(s)

Polysomnography

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

Sex
ALL
Min age
0 Years
Max age
17 Years
Healthy volunteers
No
Inclusion Criteria: * 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) Exclusion Criteria: * None

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)

FacilityCityRegionStatus
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
Official registry record

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