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ClinicalTrials.gov ID

NCT07077226

Lead Sponsor

GUIDO CAMANNIOTHER

Overall Status

Not yet recruiting

Study Type

Observational

Enrollment

150Estimated

Last Update Posted

Jul 28, 2025Actual

Start Date

Sep 15, 2025Estimated

Primary Completion Date

Oct 15, 2026Estimated

Completion Date

Apr 15, 2027Estimated

Official Title

Prevalence and Clinical Impact of Sleep-Disordered Breathing in Children With Cerebral Palsy at Increased Risk of Respiratory Disorders

Brief 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).

Detailed Description

A recent review of the scientific literature shows that in the 61 studies on sleep-disordered breathing (SDB) in children with cerebral palsy (CP), epidemiological data on the diagnosis of SDB are scarce and of unsatisfactory quality, as the data are mainly based on the use of targeted questionnaires such as the Pediatric Sleep Questionnaire (PSQ). A study published by Garcia in Developmental Medicine and Child Neurology in 2016 shows that children with CP, especially if they have epilepsy as a comorbidity, have a higher risk of SDB than healthy children.

In a study published in the Annals of Indian Academy of Neurology in 2013, Elsayed found that children with CP are at higher risk for SDB with increasing age, with a higher incidence in the school-age group than in the preschool age group. In the same study, the investigator observed a direct correlation between the severity of motor impairment (levels IV and V versus levels I - III of the Gross Motor Function Classification System scale, GMFCS) and the risk of SDB.

Dum found in 2023 in the Journal of Child Neurology a 2.91-fold (p < 0.001) increased risk of SDB in obese individuals with CP compared to normal weight individuals with CP.

In a retrospective study published in Sleep and Breathing in 2024, Kalyoncu showed good sensitivity (88.8%) of the PSQ in patients with CP, but unacceptable specificity of this instrument (30.7%) compared to polysomnography.

The primary objective of the proposed multicentre retrospective study is to assess the prevalence of SDB in children with diagnosed CP and suspected SDB who underwent polygraphic or polysomnographic examination in the period from 01/01/2020 to 12/31/2023.

A secondary objective is to assess the correlation between SDB and clinical outcome in cases where a follow-up of at least 12 months is available.

Data collected anonymously include clinical aspects (age, gender, GMFCS score, epilepsy diagnosis, adenotonsillar hypertrophy, previous adenotonsillar hypertrophy surgery, spinal changes, previous spinal surgery, oxygen therapy at home, use of Non-Invasive Ventilation/Continuous Positive Airway Pressure (NIV/CPAP) at home, presence of tracheostomy, reported snoring, reported findings of sleep apnea, Assessment of Complex Clinical-Assistance Needs in Pediatrics (ACCAPED) score, referral to a regional palliative care centre) and instrumental (evidence of obstructive sleep apnea in the final diagnosis, mean and minimum oxygen saturation (SPO2), percentage of time with SPO2 <90%, Apnea-Hypopnea Index (AHI), Mixed and Obstructive Apnea-Hypopnea Index (MOAHI), Central Apnea-Hypopnea Index (CAHI), Oxygen Desaturation Index (ODI), heart rate changes).

The following data is collected for the 12-month follow-up after the sleep study: deaths, number of emergency room visits or hospitalisations due to breathing problems, initiation of NIV/CPAP, surgery for adenotonsillar hypertrophy, tracheostomy packing.

• Sleep-disordered Breathing (SDB)

• Polysomnography

Ages Eligible for Study

Child (0-17)

Sexes Eligible for Study

All

Accepts Healthy Volunteers

No

Eligibility Criteria

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

Observational Model

Cohort

Time Perspective

Retrospective

Lead Sponsor

GUIDO CAMANNIOTHER

guidocamanni@serafico.it3406730100

elisabetta.verrillo@opbg.net+390668592020

gigi65.lm@gmail.com+390819213111

luana.nosetti@uninsubria.it+390332219988