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

Launched by CHILDREN'S HEALTH IRELAND · Sep 4, 2023

Keywords

ClinConnect Summary

This clinical trial is studying how non-invasive ventilation (a type of breathing support that doesn’t require surgery) can help children with Down Syndrome who have obstructive sleep apnea. Obstructive sleep apnea is a condition where a person has trouble breathing during sleep, which can affect their sleep quality and daily life. The researchers want to find out how this treatment affects the children’s sleep behaviors and overall quality of life, as well as what challenges families face when trying to use this type of breathing support.

To participate, children must have a confirmed diagnosis of Down Syndrome and meet certain sleep-related criteria. They should be at least 4 months old and able to participate in the study. Families will complete questionnaires before and after starting treatment, and a smaller group of participants will be invited to discuss their experiences in interviews. This study aims to gather valuable information to improve the care of children with Down Syndrome and sleep apnea, and it is currently looking for participants.

Gender

ALL

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.