At a glance
- What the study gets you
- Health checks and monitoring — no treatment given
- Type of study
- Observational (no treatment given)
- Time in hospital
- In-person visits at study sites — visit count not specified by the sponsor
- Drug or intervention
- Not specified by the sponsor
- How long the study runs
- Study runs about 16 months (dates as stated)
- About the drug or intervention
- Not specified by the sponsor
- Patient visit burden
- Not specified by the sponsor
- Type of study
- Observing health over time
- Ages
- 1 Month to 16 Years
- Who
- All
- Number of participants
- 24
- Started
- 2025-02-28
- Last checked
- 2026-06
Plain English Summary
What is this study?
- • Testing a new treatment for sleep disordered breathing (sdb)
- • Clinical study - 24 participants
- • Cerebral palsy (CP) refers to a non-progressive movement disorder, which occurs due to damage to the developing brain around the time of birth
Who can take part?
- • Ages 1 Month to 16 Years
- • Diagnosed with sleep disordered breathing (sdb)
Where?
- • Edinburgh - NHS Lothian
- • Edinburgh - Department of Paediatric Respiratory and Sleep Medicine, Royal Hospital for Children and Young People
This is a simplified summary. Always discuss with your doctor before making any decisions.
About This Trial
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. 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 analyse the experiences of children with CP being managed for SDB, and the views of their carers/parents, and health professionals involved in their care. By undertaking semi-structured interviews, the investigators aim to explore the impact SDB and it's management has on children
More detail
The journey and experience of children with CP being managed for SDB can be unique and varied. Hence a qualitive semi-structed interview will offer the best insight into their journey and learn ways to improve the experiences for other children in the future. The investigators aim to interview; * Children with CP aged \<16 years old, and able to participate in the interview. No lower age limit is defined, as children with CP can have potential underlying learning disability and chronological lower limit age cut off will not be useful in defining ability to engage with study. Instead, each child will be looked at individually with input from parents/carer to determine ability to engage with study. * Parents/carers of children with CP. There may be times where only the parent/carer is being interviewed as the child is not able to (or does not wish to) engage with the interview. Where both the child with CP and parent/carer are being interviewed, this will be done concurrently. * Healthcare professionals involved in the management of children with CP and being (or has been) managed with respiratory support for sleep disordered breathing. The investigators aim to interview 10 children with CP and/or their parents/carer and 10 health professionals, or till no new themes emerge. The participants for the interview will be identified by the members of the sleep/LTV team and/or by disseminating the study on charity sites and professional membership groups for suitable individuals to contact the research team to express interest. Those who have confirmed participation in the study will be invited for a single interview either in person or online. Written consent (on paper copy or online) will be gained before the interview. The interview will be conducted as per the relevant interview schedule for children with CP, parents/carers and health professionals. Relevant additional information about the participant will also be documented in the field notes at time of interview.
How this trial compares with your answers
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What we know so far
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- • Tell us your age for better matching
- • Tell us your sex for better matching
Preliminary match based on your answers. Full eligibility requires on-site assessment including medical history, physical exam, and lab tests. This does not guarantee enrolment.
Eligibility at a Glance
Key info
- Age: 1 Month - 16 Years
- Who can join: All genders
What the study is looking for
- ✓\- Children and young people with CP and SDB;
- ✓Children and young people aged less than (but not including) 16 years old
- ✓Formal diagnosis of Cerebral Palsy
- ✓Formal diagnosis of Sleep Disordered Breathing (currently or previously managed with respiratory support)
- ✓Able to understand, communicate (with or without aids) and engage with interview (guided by parents/carer opinion on...
Who cannot take part
- ✗Children and young people with CP and SDB and their parents/carers;
- ✗CYP with CP on respiratory support for failure to wean as neonate or for Chronic Lung Disease
- ✗CYP on respiratory support for other neuromuscular or neurodisability conditions
- ✗Health care professional; Nil
See the full criteria
Where Is This Study? (2 UK sites)
NHS Lothian
Edinburgh EH16 4TJ, United Kingdom
Department of Paediatric Respiratory and Sleep Medicine, Royal Hospital for Children and Young People
Edinburgh EH16 4TJ, United Kingdom