Clinical Outcomes From Treatment and Evaluation of Obstructive Sleep Apnoea in Children With Down Syndrome (REFRESHED)

Children's Health Ireland

Status: Enrolling

Conditions: Behavior; Adherence, Treatment; Quality of Life; Down Syndrome; Obstructive Sleep Apnea

Treatments: Device: Non-invasive ventilation

Study type: Observational

Funder types: Other

Identifiers

NCT06030349

REC137-22

Details and patient eligibility

About

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.

Full 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.

Enrollment: 200 estimated patients

Sex: All

Ages: 6 months to 16 years old

Volunteers: No Healthy Volunteers

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.

Trial design

200 participants in 2 patient groups

Standard

Description:

In addition to data from clinical assessment, sleep studies and non-invasive ventilator downloads recorded as part of standard care participants will undergo questionnaire assessment of behaviour, quality of life and barriers to tolerating treatment. Participants aged 3 years and above will receive the Child Sleep Habits Questionnaire, Obstructive Sleep Apnoea-18 questionnaire and Adherence Barriers to CPAP (Continuous Positive Airway Pressure) Questionnaire. Participants aged 6 months to 3 years will receive the Brief Infant Sleep Questionnaire, Infant Toddler Quality of Life - Short Form 47, Obstructive Sleep Apnoea -18 Caregiver Concern Domain and a modified version of the Adherence Barriers to CPAP Questionnaire.

Treatment:

Device: Non-invasive ventilation

Advanced

Description:

In addition to all elements of the standard testing group, 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.

Treatment:

Device: Non-invasive ventilation