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

NCT07077226 | Not Yet Recruiting

• 1 other identifier: DRSPCI25
• Study Type: observational
• Target: 150
• Locations: 1 country
• Sites: 9

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).

Conditions

Sleep-disordered Breathing (SDB)

Keywords

sleep-disordered breathing; cerebral palsy; Polysomnography

Outcome Measures

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.

  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.

Study Arms (1)

Children (0-17 years) with cerebral palsy who had a sleep study at an Italian reference Center.

Children (0-17 years) of either sex, diagnosed with cerebral palsy who had a sleep study (polysomnography or polygraphy) at an Italian Center during the period 01/01/2020 - 12/31/2023.

Diagnostic Test: Polysomnography

Interventions

Polysomnography DIAGNOSTIC_TEST

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

Children (0-17 years) with cerebral palsy who had a sleep study at an Italian reference Center.

Eligibility Criteria

• Age: 0 Years - 17 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)
• Sampling Method: Non-Probability Sample

Study 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

You may qualify if:

• 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)

You may not qualify if:

• None

Sponsors & Collaborators

• GUIDO CAMANNI: lead

Study Sites (9)

Uoc Hospice Pediatrico - Azienda Ospedale-Universita' Padova

Padua, PD, 35121, Italy

Location

Uoc Pronto Soccorso Pediatrico Azienda Ospedale-Universita' Padova

Padua, PD, 35128, Italy

Location

Istituto Serafico Di Assisi

Assisi, PG, 06081, Italy

Location

Ospedale Pediatrico Bambino Gesu'

Roma, RM, 00165, Italy

Location

Azienda Sanitario-Universitaria Sant'Andrea

Roma, RM, 00189, Italy

Location

Ospedale Umberto I

Salerno, SA, 84014, Italy

Location

Irccs Materno Infantile Burlo Garofolo

Trieste, TS, 34137, Italy

Location

Universita' Degli Studi Dell'Insubria

Varese, VR, 21100, Italy

Location

Azienda Sanitario-Universitaria Federico Ii

Napoli, 80138, Italy

Location

Related Publications (4)

• Kalyoncu M, Namli N, Yegit CY, Yanaz M, Gulieva A, Ergenekon AP, Selcuk M, Atag E, Ikizoglu NB, Sabanci M, Lale K, Gokdemir Y, Ersu R, Karakoc F, Karadag B, Eralp EE. Is the Pediatric Sleep Questionnaire sensitive for sleep-disordered breathing in children with complex chronic disease? Sleep Breath. 2024 Mar;28(1):331-337. doi: 10.1007/s11325-023-02915-z. Epub 2023 Sep 21.

  PMID: 37733254 BACKGROUND

• Garcia J, Wical B, Wical W, Schaffer L, Wical T, Wendorf H, Roiko S. Obstructive sleep apnea in children with cerebral palsy and epilepsy. Dev Med Child Neurol. 2016 Oct;58(10):1057-62. doi: 10.1111/dmcn.13091. Epub 2016 Mar 16.

  PMID: 26991829 BACKGROUND

• Dum R, Walter V, Thomas NJ, Krawiec C. Odds of Cardiometabolic Diseases and Medications in Children With Cerebral Palsy. J Child Neurol. 2023 Mar;38(3-4):239-246. doi: 10.1177/08830738231167534. Epub 2023 Apr 5.

  PMID: 37016991 BACKGROUND

• Elsayed RM, Hasanein BM, Sayyah HE, El-Auoty MM, Tharwat N, Belal TM. Sleep assessment of children with cerebral palsy: Using validated sleep questionnaire. Ann Indian Acad Neurol. 2013 Jan;16(1):62-5. doi: 10.4103/0972-2327.107708.

  PMID: 23661965 BACKGROUND

MeSH Terms

Conditions

Sleep Apnea Syndromes; Cerebral Palsy

Interventions

Polysomnography

Condition Hierarchy (Ancestors)

Apnea; Respiration Disorders; Respiratory Tract Diseases; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Nervous System Diseases; Brain Damage, Chronic; Brain Diseases; Central Nervous System Diseases

Intervention Hierarchy (Ancestors)

Monitoring, Physiologic; Diagnostic Techniques and Procedures; Diagnosis

Study Officials

• LUIGI MASINI, MD

  OSPEDALE UMBERTO I, SALERNO

  STUDY CHAIR

Central Study Contacts

GUIDO CAMANNI, MD

CONTACT

+393406730100; guidocamanni@serafico.it

ORNELLA CICCONE, MD

CONTACT

+39075812411; ornellaciccone@serafico.it

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Medical Doctor

Study Record Dates

• First Submitted: July 11, 2025
• First Posted: July 22, 2025
• Study Start: September 15, 2025
• Primary Completion (Estimated): October 15, 2026
• Study Completion (Estimated): April 15, 2027
• Last Updated: July 28, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL
• Time Frame: IPD will be made available for a period of 5 years after completion of the study.
• Access Criteria: Substantiated applications for IPD from interested researchers should be sent by e-mail to the sponsor-investigator.

Locations

IT (9)