Evaluating non-invasive ventilation for sleep apnea in children with Down syndrome
Real World Clinical Outcomes From Treatment and Evaluation of Obstructive Sleep Apnoea Syndrome in Children With Down Syndrome
This study is trying to see if using a non-invasive breathing machine can help children with Down syndrome who have sleep apnea sleep better and improve their quality of life.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 200 (estimated) |
| Ages | 6 Months to 16 Years |
| Sex | All |
| Sponsor | Children's Health Ireland Government |
| Locations | 6 sites (Dublin and 5 other locations) |
| Trial ID | NCT06030349 on ClinicalTrials.gov |
What this trial studies
This observational study aims to assess the effects of non-invasive ventilation on sleep behaviors and quality of life in children diagnosed with Down syndrome who suffer from obstructive sleep apnea. Participants will complete questionnaires before and after treatment, and their data will be compared with sleep studies and ventilator downloads as part of standard care. Additionally, a subgroup of participants will engage in interviews to discuss their experiences and barriers related to the treatment. The study seeks to identify both the benefits of the treatment and the challenges families face in adhering to it.
Who should consider this trial
Good fit: Ideal candidates are children aged 4 months and older with Down syndrome who have been diagnosed with obstructive sleep apnea and are starting non-invasive ventilation.
Not a fit: Patients who are already on ventilatory support devices or those with artificial airways may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could improve the quality of life and treatment adherence for children with Down syndrome suffering from obstructive sleep apnea.
How similar studies have performed: While there have been studies on non-invasive ventilation in other populations, this specific focus on children with Down syndrome is relatively novel.
Eligibility criteria
Show full inclusion / exclusion 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.
Where this trial is running
Dublin and 5 other locations
- Trinity College Dublin — Dublin, Ireland (Recruiting)
- Children's Health Ireland — Dublin, Ireland (Recruiting)
- Royal Belfast Hospital for Sick Children — Belfast, United Kingdom (Not_yet_recruiting)
- Birmingham Children's Hospital — Birmingham, United Kingdom (Not_yet_recruiting)
- Royal Hospital for Children & Young People — Edinburgh, United Kingdom (Not_yet_recruiting)
- Southampton Children's Hospital — Southampton, United Kingdom (Not_yet_recruiting)
Study contacts
- Principal investigator: Sheila Javadpour — Children's Health Ireland
- Study coordinator: Roy G Stone
- Email: refreshed@olchc.ie
- Phone: 0035314282626
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.