Trials / Recruiting
RecruitingNCT06030349
Clinical Outcomes From Treatment and Evaluation of Obstructive Sleep Apnoea in Children With Down Syndrome
Real World Clinical Outcomes From Treatment and Evaluation of Obstructive Sleep Apnoea Syndrome in Children With Down Syndrome
- Status
- Recruiting
- Phase
- —
- Study type
- Observational
- Enrollment
- 200 (estimated)
- Sponsor
- Children's Health Ireland · Other Government
- Sex
- All
- Age
- 6 Months – 16 Years
- Healthy volunteers
- Not accepted
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DEVICE | Non-invasive ventilation | Non-invasive ventilation |
Timeline
- Start date
- 2022-11-28
- Primary completion
- 2027-11-28
- Completion
- 2027-12-28
- First posted
- 2023-09-11
- Last updated
- 2024-02-12
Locations
6 sites across 2 countries: Ireland, United Kingdom
Source: ClinicalTrials.gov record NCT06030349. Inclusion in this directory is not an endorsement.