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

NCT ID: NCT07077226

Last Updated: 2025-07-28

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Total Enrollment: 150 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2025-09-15
• Study Completion Date: 2027-04-15

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.

Conditions

Sleep-disordered Breathing (SDB)

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: RETROSPECTIVE

Study Groups

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.

Polysomnography

Intervention Type: DIAGNOSTIC_TEST

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

Interventions

Polysomnography

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

Intervention Type: DIAGNOSTIC_TEST

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

• Minimum Eligible Age: 0 Years
• Maximum Eligible Age: 17 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

GUIDO CAMANNI

OTHER

Sponsor Role: lead

Responsible Party

GUIDO CAMANNI

Medical Doctor

Responsibility Role: SPONSOR_INVESTIGATOR

Principal Investigators

LUIGI MASINI, MD

Role: STUDY_CHAIR

OSPEDALE UMBERTO I, SALERNO

Locations

Uoc Hospice Pediatrico - Azienda Ospedale-Universita' Padova

Padua, PD, Italy

Uoc Pronto Soccorso Pediatrico Azienda Ospedale-Universita' Padova

Padua, PD, Italy

Istituto Serafico Di Assisi

Assisi, PG, Italy

Ospedale Pediatrico Bambino Gesu'

Roma, RM, Italy

Azienda Sanitario-Universitaria Sant'Andrea

Roma, RM, Italy

Ospedale Umberto I

Salerno, SA, Italy

Irccs Materno Infantile Burlo Garofolo

Trieste, TS, Italy

Universita' Degli Studi Dell'Insubria

Varese, VR, Italy

Azienda Sanitario-Universitaria Federico Ii

Napoli, , Italy

Countries

Italy

Central Contacts

GUIDO CAMANNI, MD

Role: CONTACT

guidocamanni@serafico.it

+393406730100

ORNELLA CICCONE, MD

Role: CONTACT

ornellaciccone@serafico.it

+39075812411

Facility Contacts

FRANCA BENINI, MD

Role: primary

franca.benini@aopd.veneto.it

+390498211628

TIZIANA ZANGARDI, MD

Role: primary

tiziana.zangardi@aopd.veneto.it

+390498211111

GUIDO CAMANNI, MD

Role: primary

guidocamanni@serafico.it

3406730100

ORNELLA CICCONE, MD

Role: backup

ornellaciccone@serafico.it

+390758124111

ELISABETTA VERRILLO, MD

Role: primary

elisabetta.verrillo@opbg.net

+390668592020

MELANIA EVANGELISTI, MD

Role: primary

melania.evangelisti@uniroma1.it

+390633771

LUIGI MASINI, MD

Role: primary

gigi65.lm@gmail.com

+390819213111

SERGIO GHIRARDO, MD

Role: primary

sergio.ghirardo@burlo.trieste.it

+390403785111

LUANA NOSETTI, MD

Role: primary

luana.nosetti@uninsubria.it

+390332219988

MELISSA BORRELLI, MD

Role: primary

melissaborrelli00@gmail.com

+390812531111

References

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.

Reference Type: BACKGROUND

PMID: 37733254 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 26991829 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 37016991 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 23661965 (View on PubMed)

Other Identifiers

DRSPCI25

Identifier Type: -

Identifier Source: org_study_id