Experiences of Managing Sleep Disordered Breathing in Children With Cerebral Palsy. (QualSDB_CP)

June 12, 2026 updated by: University of Edinburgh

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.

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

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Active, not recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

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 Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
25

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • United Kingdom
    • Edinbrugh
      • Edinburgh, Edinbrugh, United Kingdom, EH16 4TJ
        • Nhs Lothian
    • Merseyside
      • Edinburgh, Merseyside, United Kingdom, EH16 4TJ
        • Department of Paediatric Respiratory and Sleep Medicine, Royal Hospital for Children and Young People

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Child

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

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.

Description

Inclusion Criteria:

- 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;

  • 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

Exclusion Criteria:

  • 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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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).
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.
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).
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.
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).
From enrolment till end of study at 6 months

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Facilitators of establishing respiratory support
Time Frame: From enrollment till end of study at 6 months
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).
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
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).
From enrollment till end of study at 6 months
Accessibility to sleep services
Time Frame: From enrollment till end of study at 6 months
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).
From enrollment till end of study at 6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
University of Edinburgh

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
February 28, 2025

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
May 31, 2026

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
August 1, 2026

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
December 9, 2024

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
December 20, 2024

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
December 31, 2024

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
June 15, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 12, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
June 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • AC24190

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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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