Sleep Disordered Breathing (SDB)QualSDB_CPNCT06753370
Experiences of Managing Sleep Disordered Breathing in Children With Cerebral Palsy.
An observational study of Sleep Disordered Breathing (SDB) and Cerebral Palsy (CP), run by University of Edinburgh at 2 sites in United Kingdom.
Trial 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. Read more about this study
- Who is it for?
- Ages 1 month to 16 years
- Conditions the study is for
- Sleep Disordered Breathing (SDB), Cerebral Palsy (CP), Respiratory Support
- How many people
- 24 participants
- Where
- 2 sitesUnited Kingdom
- Study dates
- 28 Feb 2025to 1 Jun 2026
- Phase
- Observational
- Are there results?
- None posted in the registry
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 1 month to 16 years
- All sexes
- No healthy volunteers
- Child
Study population: Children and young people with cerebral palsy who are (or have been) managed with respiratory support for sleep disordered breathing, their parents/carer and health professionals involved in their care.
Who may be able to join
- 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 capacity to engage in interview)
- Parents/carers of CYP with CP;
Show all 9Show fewer
- Parents/carer of CYP with CP and SDB being (or has been) managed with respiratory support
- Health care professional;
- Professionals (based in community or hospital setting) involved in the management of SDB in CYP with CP
Who cannot join
- 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
Trial locations and contacts
2 sites in 1 country.
United Kingdom2 sites
NHS Lothian
Edinburgh, Edinbrugh, EH16 4TJ
Department of Paediatric Respiratory and Sleep Medicine, Royal Hospital for Children and Young People
Edinburgh, Merseyside, EH16 4TJ
About this study
Official title: Experiences of Children and Young People (CYP) With Cerebral Palsy (CP), Their Parents/Caregivers and Healthcare Professionals in Managing Sleep Disordered Breathing (SDB).
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.
Read more
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
Read the detailed description
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.
- Keywords
- sleep disordered breathing, cerebral palsy, respiratory support, qualitative research
- Medical subject headings
- Sleep Apnea Syndromes, Cerebral Palsy
What is being measured
The primary outcome is the main question the study is designed to answer.
Themes describing experiences of assessment and management of sleep disordered breathing in children and young people with CP
Themes describing the experience of children and young people (CYP) with CP in the assessment and management (with respiratory support) of SDB. Emerging themes will be identified through matrix analysis of semi-structured interview (with a phenomenology methodology).
Measured: From enrolment till end of study at 6 months
Themes describing experiences of assessment and management of sleep disordered breathing in family members and carers of children with CP.
Themes describing the experience of family member/carer in the assessment and management (with respiratory support) of SDB in CYP with CP. Emerging themes will be identified through matrix analysis of semi-structured interview (with a phenomenology methodology).
Measured: From enrollment till end of study at 6 months
Themes describing experiences of assessment and management of sleep disordered breathing in healthcare professionals of children with CP.
Themes describing the experience of healthcare professionals in the assessment and management (with respiratory support) of SDB in CYP with CP. Emerging themes will be identified through matrix analysis of semi-structured interview (with a phenomenology methodology).
Measured: From enrolment till end of study at 6 months
Secondary outcomes (3)
Facilitators of establishing respiratory support
Factors which facilitate initiation and establishing respiratory support for SDB in CYP with CP will be identified through matrix analysis of semi-structured interviews for emerging themes (with a phenomenology methodology).
Measured: From enrollment till end of study at 6 months
Barriers to establishing respiratory support
Factors which act as barriers to setting up and establishing respiratory support for SDB in CYP with CP will be identified through matrix analysis of semi-structured interviews for emerging themes (with a phenomenology methodology).
Measured: From enrollment till end of study at 6 months
Accessibility to sleep services
Strategies to improve accessibility to sleep services for managing SDB in CYP with CP will be identified through matrix analysis of semi-structured interviews for emerging themes (with a phenomenology methodology).
Measured: From enrollment till end of study at 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Dec 2024
- Study start28 Feb 2025
- Primary completion31 May 2026
- Study completion1 Jun 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Sleep Disordered Breathing (SDB)Studies of the same condition, open and under way.
- More trials run by University of EdinburghThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- Prospective
- Enrolment
- 24 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Edinburgh
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06753370
- Sponsor's protocol ID
- AC24190
- Acronym
- QualSDB_CP
- Status last verified
- Jun 2026
- First submitted
- 9 Dec 2024
- Last updated
- 26 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Experiences of Children and Young People (CYP) With Cerebral Palsy (CP), Their Parents/Caregivers and Healthcare Professionals in Managing Sleep Disordered Breathing (SDB).
- ClinicalTrials.gov ID
- NCT06753370
- Acronym / sponsor ID
- QualSDB_CP / AC24190
- Keywords
- sleep disordered breathing, cerebral palsy, respiratory support, qualitative research
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 24 participants (actual)
- Lead sponsor
- University of EdinburghUniversity, hospital or other
- Study start
- 28 Feb 2025 (actual)
- Primary completion
- 31 May 2026 (actual)
- Study completion
- 1 Jun 2026 (actual)
- First posted
- 31 Dec 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Detailed description
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 1 month to 16 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- Study population
- Children and young people with cerebral palsy who are (or have been) managed with respiratory support for sleep disordered breathing, their parents/carer and health professionals involved in their care.
Key inclusion criteria (9 listed)
- 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 capacity to engage in interview)
Key exclusion criteria (4 listed)
- Children and young people with CP and SDB and their parents/carers;
- Health care professional; Nil
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Themes describing experiences of assessment and management of sleep disordered breathing in children and young people with CP
Time frame: From enrolment till end of study at 6 months
Themes describing the experience of children and young people (CYP) with CP in the assessment and management (with respiratory support) of SDB. Emerging themes will be identified through matrix analysis of semi-structured interview (with a phenomenology methodology).
Themes describing experiences of assessment and management of sleep disordered breathing in family members and carers of children with CP.
Time frame: From enrollment till end of study at 6 months
Themes describing the experience of family member/carer in the assessment and management (with respiratory support) of SDB in CYP with CP. Emerging themes will be identified through matrix analysis of semi-structured interview (with a phenomenology methodology).
Themes describing experiences of assessment and management of sleep disordered breathing in healthcare professionals of children with CP.
Time frame: From enrolment till end of study at 6 months
Themes describing the experience of healthcare professionals in the assessment and management (with respiratory support) of SDB in CYP with CP. Emerging themes will be identified through matrix analysis of semi-structured interview (with a phenomenology methodology).
3 secondary outcomes
Facilitators of establishing respiratory support
Time frame: From enrollment till end of study at 6 months
Barriers to establishing respiratory support
Time frame: From enrollment till end of study at 6 months
Accessibility to sleep services
Time frame: From enrollment till end of study at 6 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Jun 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Sleep Disordered Breathing (SDB) and Cerebral Palsy (CP), run by University of Edinburgh at 2 sites in United Kingdom.
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 9 inclusion and 4 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: finished, as of the sponsor's last update on 26 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United Kingdom. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Themes describing experiences of assessment and management of sleep disordered breathing in children and young people with CP (time frame: From enrolment till end of study at 6 months). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 26 Jun 2026.