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

Trial statusNot yet recruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age0-17
SponsorGUIDO CAMANNI

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 volunteers

Qualifiers

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

Design model

Cohort

Time perspective

Retrospective

Treatments tested in this trial

  • Polysomnography

    Diagnostic test

    Sleep studies (polysomnography and polygraphy) will be performed and reported according to current American Academy of Sleep Medicine guidelines

Treatment groups

150 Participants
are divided into 1 treatment group
Group A: Children (0-17 years) with cerebral palsy who had a sleep study at an Italian reference Center.1 intervention

Trial outcomes

Primary outcomes

1

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.

Time frame
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.

Secondary outcomes

Other outcomes

Sponsors and contacts

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GUIDO CAMANNI

Lead sponsor

Istituto Serafico per sordomuti e per ciechi

Sponsor institution

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