Epidemiology of Sleep Disordered Breathing in Children and Young People With Cerebral Palsy (UK_CPSSS)

Epidemiology (and Natural History) of Sleep Disordered Breathing and Respiratory Support in Children and Young People With Cerebral Palsy

Cerebral palsy (CP) refers to a non-progressive movement disorder, which occurs due to damage to the developing brain around the time of birth. Symptoms of sleep disordered breathing (SDB) include noisy breathing during sleep,increased day-time sleepiness and reduced energy levels. In the long term, SDB might have an effect on the brain and learning, as well as putting strain on the heart.

Children with CP have a higher risk of sleep breathing problems compared to typically-developing children, and the negative impact of sleep disturbance in children with CP on their family members/carers' sleep and mental health cannot be understated. Early recognition and management of SDB is important for children with CP to give these children the best possible sleep quality, and to maximise learning potential.

SDB in children with CP is often under-recognised and under-treated. Treatment of SDB in children with CP might involve wearing a mask that delivers pressurised air to hold open a child's airway and make breathing easier when they are asleep. This is called 'respiratory support' which can be continuous pressure (CPAP) or non-invasive ventilation (NIV) which is pressure support with a back-up breathing rate. There is limited knowledge on the appropriate indications or timing to use them.

Though respiratory support in children with CP is proven to help with breathing during sleep, its impact on quality of life, number of hospital admissions or frequency of chest infections is unknown.

This study will look at the number of children with CP on respiratory support across the UK, as well as the number of children newly diagnosed with SDB and/or established on respiratory support over a 1-year period. This study will also explore socioeconomic factors that might influence access of sleep services and the perceived facilitators and barriers to successfully initiating respiratory support in children with CP.

Study Overview

• Status: Recruiting
• Conditions: Cerebral Palsy (CP); Respiratory Support; Sleep Disordered Breathing (SDB)

Detailed Description

The study will be conducted as a nationwide UK Sleep Surveillance Survey of children with cerebral palsy. It will be conducted as a two-part survey (UK-wide point prevalence survey and UK-wide Incidence self-reporting form).

There is no national registry of children with cerebral palsy (CP) which collects information on sleep or sleep disordered breathing (SDB) for the purpose of this study. Hence, the investigators will recruit all tertiary paediatric centres across the UK which offers sleep services to children. A single point of contact will be identified for further communication and to act as local champion for collecting the relevant information in each centre.

I) National point prevalence survey;

• Single point of contact (PoCo) identified across tertiary paediatric centre which offer sleep services
• Single questionnaire sent on pre-specified date to PoCo in each centre

• Study will aim to;

  • assess number of children in each centre with CP established on respiratory support
  • gather information on practices in different centres pertaining to their assessment and management of children with CP and suspected SDB

II) National Incidence self reporting form;

• This phase of the review will a conducted over a 1-year period

• Will be conducted as a 2-part survey, with the PoCo being sent a monthly self-reporting form;

  • Part A;

    • To identify number of children with CP who underwent sleep study, the proportion of those who were diagnosed with SDB, and the total number of children with CP who were initiated on respiratory support (regardless of sleep study results) in that calendar month
    • To be completed by PoCo in all centres
    • If any children with CP were newly initiated on respiratory support (regardless of sleep study results), PoCo will be directed to complete Part B

  • Part B;

    • Will gather further information on children with CP who were initiated on respiratory support in the calendar month (regardless of sleep study results), with a separate form for each child
    • Data collected will assess association between socio-economic factors (ethnicity, social deprivation index and urban-rural classification) and diagnosis of sleep disordered breathing and/or being initiated on respiratory support in children with CP
• No power calculation has been done for this review, as this is an observational study with an aim to include all children with cerebral palsy, newly diagnosed with SDB and/or started on respiratory support in the UK

• Study Type: Observational
• Enrollment (Estimated): 50

Contacts and Locations

• Study Contact: Name: Research Fellow; Phone Number: + 44 01313121124; Email: rajkumar.dhandayuthapani@nhs.scot

Study Locations

• United Kingdom
  • Edinbrugh
    • Edinburgh, Edinbrugh, United Kingdom, EH16 4TJ
      • Recruiting
      • Nhs Lothian
      • Contact: Dhandayuthapani Rajkumar, MBChB; Phone Number: 07503371794; Email: rajkumar.dhandayuthapani@nhs.scot

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

UK (England, Scotland, Wales and Northern Ireland)

Description

Inclusion Criteria:

Cases for Prevalence survey;

• Any child aged ≤16 years old, with a confirmed diagnosis of cerebral palsy
• On respiratory support on the date of prevalence survey

Cases for Incidence self-reporting form;

• Part A;

  • Any Child aged ≤16 years old, with confirmed diagnosis of cerebral palsy
  • Had sleep studies for suspected sleep disordered breathing within the preceding calendar month

• Part B;

  • Any Child aged ≤16 years old, with a confirmed diagnosis of cerebral palsy
  • Initiated respiratory support (CPAP or NIV or invasive tracheostomy ventilation) in the preceding month

Exclusion Criteria: (For prevalence survey and incidence self-reporting form)

• Any patient aged >16 years old
• Patient does not have a confirmed diagnosis of cerebral palsy

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Prevelance	Identify the prevalence of children with cerebral palsy on respiratory support across the UK	Day 1 of study
Incidence	Identify the incidence of children with CP newly diagnosed with sleep disordered breathing across the UK	13 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Screening questionnaire	Type of questionnaire used for screening for SDB in children with CP	13 months
Types of sleep studies	Types of sleep studies used across the UK in investigating SDB in children with CP	13 months
Types of respiratory support	Types of respiratory support offered for managing SDB for children with CP	13 months
Indications for starting respiratory support	Quantify the indications for starting respiratory support in each child with CP	13 months
Social deprivation	Explore association between social deprivation and likelihood of accessing and/or initiating respiratory support for SDB	13 months
Ethnicity	Explore association between ethnicity and likelihood of accessing and/or initiating respiratory support for SDB	13 months
Geographical location	Visualization of regions with underrepresentation/reporting of children with CP needing respiratory support for SDB	13 months
Facilitators	Quantify perceived facilitators to successfully setting up and establishing respiratory support for SDB in children with CP	13 months
Barriers	Quantify perceived barriers to successfully setting up and establishing respiratory support for SDB in children with CP	13 months

Collaborators and Investigators

• Sponsor: University of Edinburgh

Study record dates

Study Major Dates

• Study Start (Actual): March 1, 2025
• Primary Completion (Estimated): May 1, 2026
• Study Completion (Estimated): August 1, 2026

Study Registration Dates

• First Submitted: December 6, 2024
• First Submitted That Met QC Criteria: December 11, 2024
• First Posted (Actual): December 17, 2024

Study Record Updates

• Last Update Posted (Actual): January 21, 2026
• Last Update Submitted That Met QC Criteria: January 16, 2026
• Last Verified: January 1, 2026

More Information

Terms related to this study

• Keywords: cerebral palsy; sleep disordered breathing; respiratory support
• Additional Relevant MeSH Terms: Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Respiratory Tract Diseases; Respiration Disorders; Sleep Wake Disorders; Apnea; Sleep Disorders, Intrinsic; Dyssomnias; Brain Damage, Chronic; Sleep Apnea Syndromes; Cerebral Palsy
• Other Study ID Numbers: AC24189

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No