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

NCT06737302 | Recruiting

• 1 other identifier: AC24189
• Study Type: observational
• Target: 50
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Sleep Disordered Breathing (SDB); Respiratory Support; Cerebral Palsy (CP)

Keywords

sleep disordered breathing; cerebral palsy; respiratory support

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (9)

• Screening questionnaire

  13 months

• Types of sleep studies

  13 months

• Types of respiratory support

  13 months

• Indications for starting respiratory support

  13 months

• Social deprivation

  13 months

Eligibility Criteria

• Age: 1 Month - 16 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)
• Sampling Method: Non-Probability Sample

Study Population

UK (England, Scotland, Wales and Northern Ireland)

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• University of Edinburgh: lead

Study Sites (1)

NHS Lothian

Edinburgh, Edinbrugh, EH16 4TJ, United Kingdom

RECRUITING

MeSH Terms

Conditions

Cerebral Palsy; Sleep Apnea Syndromes

Condition Hierarchy (Ancestors)

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

Central Study Contacts

Research Fellow

CONTACT

+ 44 01313121124; rajkumar.dhandayuthapani@nhs.scot

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 6, 2024
• First Posted: December 17, 2024
• Study Start: March 1, 2025
• Primary Completion: May 1, 2026
• Study Completion (Estimated): August 1, 2026
• Last Updated: January 21, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)