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

Study acronym: UK_CPSSS
StatusCompleted
PhaseNot specified
Started
View on ClinicalTrials.gov ↗

Record History

  1. Minor Trial completed Study completion date changed from estimate of Aug 2026 to Aug 31, 2026 · Eligibility criteria expanded, about 10 words · Secondary endpoints: details revised at 3 of 9 entries · 1 more Show 4 more changesShow less
    • Study completion date changed from estimate of Aug 2026 to Aug 31, 2026
    • Eligibility criteria expanded, about 10 words
    • Secondary endpoints: details revised at 3 of 9 entries
    • Study description expanded, about 15 words
  2. Notable Enrollment reduced: 50 → 26 participants Trial status changed: Recruiting → Active, Not Recruiting · Primary completion pushed from May 2026 to May 31, 2026 · Site details revisedv4 Show 3 more changesShow less
    • Trial status changed: Recruiting → Active, Not Recruiting
    • Primary completion pushed from May 2026 to May 31, 2026
    • Site details revised
  3. Minor Re-verified, no change to tracked fieldsv3
  4. Notable Trial status: Not Yet Recruiting to Recruiting Start date changed from estimate of Apr 2025 to Mar 1, 2025 · Site details revisedv2 Show 2 more changesShow less
    • Start date changed from estimate of Apr 2025 to Mar 1, 2025
    • Site details revised
  5. Minor Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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.
Trial Details
NCT Number NCT06737302
Lead Sponsor University of Edinburgh
Conditions Cerebral Palsy (CP), Sleep Disordered Breathing (SDB), Respiratory Support
Enrollment 26 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov