AzTrials
AzTrials

Sleep-disordered Breathing (SDB)NCT07077226

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

An observational study of Sleep-disordered Breathing (SDB), run by GUIDO CAMANNI at 9 sites in Italy.

Not yet recruiting

Opening soon. The study is approved but enrolment has not started yet. Sites may already take enquiries.

Sites and contacts
Official record
Search all trials

Trial 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… Read more about this study

Who is it for?
Ages 0 to 17 years
Conditions the study is for
Sleep-disordered Breathing (SDB)
What is being tested?
Polysomnography
How many people
150 participants
Where
9 sitesItaly
Study dates
15 Sep 2025to 15 Apr 2027
Phase
Observational
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 0 to 17 years
  • All sexes
  • No healthy volunteers
  • Child

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

Who may be able to join

  • 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)

Who cannot join

  • None

Trial locations and contacts

9 sites in 1 country. Contact the study team or a site near you to ask about taking part.

GUIDO CAMANNI, MD contact

+393406730100

guidocamanni@serafico.it

ORNELLA CICCONE, MD contact

+39075812411

ornellaciccone@serafico.it

9 sites in 1 country

Italy9 sites

  • Istituto Serafico Di Assisi

    Assisi, PG, 06081

    GUIDO CAMANNI, MD, 3406730100, guidocamanni@serafico.it

    ORNELLA CICCONE, MD, +390758124111, ornellaciccone@serafico.it

  • Azienda Sanitario-Universitaria Federico Ii

    Naples, 80138

    MELISSA BORRELLI, MD, +390812531111, melissaborrelli00@gmail.com

    MELISSA BORRELLI, MD

  • Uoc Hospice Pediatrico - Azienda Ospedale-Universita' Padova

    Padova, PD, 35121

    FRANCA BENINI, MD, +390498211628, franca.benini@aopd.veneto.it

    FRANCA BENINI, MD

  • Uoc Pronto Soccorso Pediatrico Azienda Ospedale-Universita' Padova

    Padova, PD, 35128

    TIZIANA ZANGARDI, MD, +390498211111, tiziana.zangardi@aopd.veneto.it

    TIZIANA ZANGARDI, MD

  • Ospedale Pediatrico Bambino Gesu'

    Roma, RM, 00165

    ELISABETTA VERRILLO, MD, +390668592020, elisabetta.verrillo@opbg.net

    ELISABETTA VERRILLO, MD

  • Azienda Sanitario-Universitaria Sant'Andrea

    Roma, RM, 00189

    MELANIA EVANGELISTI, MD, +390633771, melania.evangelisti@uniroma1.it

    MELANIA EVANGELISTI, MD

  • Ospedale Umberto I

    Salerno, SA, 84014

    LUIGI MASINI, MD, +390819213111, gigi65.lm@gmail.com

    LUIGI MASINI, MD

  • Irccs Materno Infantile Burlo Garofolo

    Trieste, TS, 34137

    SERGIO GHIRARDO, MD, +390403785111, sergio.ghirardo@burlo.trieste.it

    SERGIO GHIRARDO, MD

  • Universita' Degli Studi Dell'Insubria

    Varese, VR, 21100

    LUANA NOSETTI, MD, +390332219988, luana.nosetti@uninsubria.it

    LUANA NOSETTI, MD

Other trials in Italy

About this study

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

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).

Read the 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.

Being tested
Polysomnography
Keywords
sleep-disordered breathing, cerebral palsy, Polysomnography
Medical subject headings
Sleep Apnea Syndromes, Cerebral Palsy

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • PolysomnographyDiagnostic test

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

Study groups in NCT07077226
Study groupRoleWhat they receive
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.
Receives: Diagnostic Test: Polysomnography

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

    Measured: 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.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted22 Jul 2025
  2. Study start15 Sep 2025 (estimated)
  3. Primary completion15 Oct 2026 (estimated)
  4. Study completion15 Apr 2027 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Retrospective
Enrolment
150 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07077226
Sponsor's protocol ID
DRSPCI25
Status last verified
Jul 2025
First submitted
11 Jul 2025
Last updated
28 Jul 2025
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes: All collected IPD.

Publications

  • 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.

    PubMed 37733254

  • 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.

    PubMed 26991829

  • 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.

    PubMed 37016991

  • 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.

    PubMed 23661965

Questions about this trial

What is this clinical trial studying?

An observational study of Sleep-disordered Breathing (SDB), run by GUIDO CAMANNI at 9 sites in Italy.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: opening soon, as of the sponsor's last update on 28 Jul 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 9 sites in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact GUIDO CAMANNI, MD (+393406730100, guidocamanni@serafico.it), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Number of Participants with obstructive sleep apnea in the study group (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.). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07077226, which also lists 4 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Jul 2025.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in