Clinical trial NCT06030349: Clinical Outcomes From Treatment and Evaluation of Obstructive Sleep Apnoea in Children With Down Syndrome
Official title: Real World Clinical Outcomes From Treatment and Evaluation of Obstructive Sleep Apnoea Syndrome in Children With Down Syndrome
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Obstructive Sleep Apnea
Down Syndrome
Quality of Life
Behavior
Adherence, Treatment
Lead sponsor: Children's Health Ireland
Sponsor class: OTHER_GOV
Collaborators: name: University of Edinburgh
name: Birmingham Children's Hospital
name: Belfast Health and Social Care Trust
name: University Hospital Southampton NHS Foundation Trust
name: University of Dublin, Trinity College
First posted: 2023-09-11
Enrollment: 200
Sex: ALL
Minimum age (years): 6
Maximum age (years): 16
Standard ages: CHILD
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Children with Down Syndrome referred for evaluation for suspected sleep disordered breathing

Brief summary: The goal of this observational study is to learn about the use of non-invasive ventilation for treatment of obstructive sleep apnoea syndrome in children with Down Syndrome. The main questions it aims to answer are:

* What is the impact of non-invasive ventilation on sleep behaviours and quality of life?
* What barriers are faced by children and their families in establishing tolerance to non-invasive ventilation?

Participants will be asked to complete questionnaires before and after starting treatment. Researchers will compare this data with the results of sleep studies and non-invasive ventilator downloads recorded as part of standard medical care. A sub-group of up to 20 participants will be invited to take part in 45-60 minute interviews exploring expectations, experiences and barriers encountered during non-invasive ventilation therapy.

Detailed description: Our aim is to examine the impact of non-invasive ventilation for treatment of obstructive sleep apnoea syndrome in children with Down Syndrome on behavioural and quality of life outcomes and to establish the specific barriers experienced in establishing adherence to treatment.

Information from clinical assessment, sleep studies and device downloads recorded as part of standard care will be combined with questionnaire data to assess for changes in behaviour and quality of life. All participants will undergo questionnaire assessment of barriers experienced. A sub-group of up to 20 participants will be invited to take part in 45-60 minute semi-structured interviews exploring expectations, experiences and barriers encountered.

Eligibility criteria: Inclusion Criteria:

* Individuals with a confirmed diagnosis of Down Syndrome where a clinical decision has been made to initiate respiratory support with non-invasive ventilation.
* Obstructive Apnoea Hypopnoea Index \> 2 episodes/hour or where sleep disordered breathing symptoms occur in combination with an Apnoea Hypopnoea Index \> 1 episode/hr. - English language proficiency.
* Age ≥ 4 months at the commencement of therapy.

Exclusion Criteria:

* Individuals not willing to comply with study procedures or assessments.
* Individuals for whom ventilatory support devices are already prescribed and those with artificial airways.
* Individuals on clinical trials of investigational support therapies.

Primary outcomes:
measure: To determine the effect of treatment of obstructive sleep apnoea syndrome with non-invasive ventilation on quality of life in children with Down Syndrome > 3 years.
timeFrame: Prior to and following 8 weeks attempted initiation of non-invasive ventilation treatment
measure: To determine the effect of treatment of obstructive sleep apnoea syndrome with non-invasive ventilation on quality of life in children with Down Syndrome < 3 years.
timeFrame: Prior to and following 8 weeks attempted initiation of non-invasive ventilation treatment
measure: To determine the effect of treatment of obstructive sleep apnoea syndrome with non-invasive ventilation on caregiver concerns regarding sleep disordered breathing for caregivers of children with Down Syndrome < 3 years.
timeFrame: Prior to and following 8 weeks attempted initiation of non-invasive ventilation treatment
measure: To determine the effect of treatment of obstructive sleep apnoea with non-invasive ventilation on sleep behaviours in children with Down Syndrome > 3 years.
timeFrame: Prior to and following 8 weeks attempted initiation of non-invasive ventilation treatment
measure: To determine the effect of treatment of obstructive sleep apnoea with non-invasive ventilation on sleep behaviours in children with Down Syndrome < 3 years.
timeFrame: Prior to and following 8 weeks attempted initiation of non-invasive ventilation treatment
measure: To establish the specific barriers to adherence faced by children > 3 years with Down Syndrome and their caregivers when starting non-invasive ventilation for the treatment of obstructive sleep apnoea syndrome
timeFrame: Prior to and following 8 weeks attempted initiation of non-invasive ventilation treatment
measure: To establish the specific barriers to adherence faced by children < 3 years with Down Syndrome and their caregivers when starting non-invasive ventilation for the treatment of obstructive sleep apnoea syndrome
timeFrame: Prior to and following 8 weeks attempted initiation of non-invasive ventilation treatment
measure: Assessment of expectations, experiences and barriers experienced by families in the treatment of obstructive sleep apnoea syndrome with non-invasive ventilation
timeFrame: After 8 weeks of attempted initiation of non-invasive ventilation
Secondary outcomes:
Other outcomes:
Locations:
city: Dublin
country: Ireland
facility: Trinity College Dublin
city: Dublin
country: Ireland
facility: Children's Health Ireland
city: Belfast
country: United Kingdom
facility: Royal Belfast Hospital for Sick Children
city: Birmingham
country: United Kingdom
facility: Birmingham Children's Hospital
city: Edinburgh
country: United Kingdom
facility: Royal Hospital for Children & Young People
city: Southampton
country: United Kingdom
facility: Southampton Children's Hospital
Study officials:
affiliation: Children's Health Ireland
name: Sheila Javadpour
role: PRINCIPAL_INVESTIGATOR
References: