NCT06030349 Clinical Outcomes From Treatment and Evaluation of Obstructive Sleep Apnoea in Children With Down Syndrome
| NCT ID | NCT06030349 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Children's Health Ireland |
| Condition | Obstructive Sleep Apnea |
| Study Type | OBSERVATIONAL |
| Enrollment | 200 participants |
| Start Date | 2022-11-28 |
| Primary Completion | 2027-11-28 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 200 participants in total. It began in 2022-11-28 with a primary completion date of 2027-11-28.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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.
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.
Contact & Investigator
Sheila Javadpour
PRINCIPAL INVESTIGATOR
Children's Health Ireland
Frequently Asked Questions
Who can join the NCT06030349 clinical trial?
This trial is open to participants of all sexes, aged 6 Months or older, up to 16 Years, studying Obstructive Sleep Apnea. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06030349 currently recruiting?
Yes, NCT06030349 is actively recruiting participants. Contact the research team at refreshed@olchc.ie for enrollment information.
Where is the NCT06030349 trial being conducted?
This trial is being conducted at Dublin, Ireland, Dublin, Ireland, Belfast, United Kingdom, Birmingham, United Kingdom and 2 additional locations.
Who is sponsoring the NCT06030349 clinical trial?
NCT06030349 is sponsored by Children's Health Ireland. The principal investigator is Sheila Javadpour at Children's Health Ireland. The trial plans to enroll 200 participants.