Evaluating non-invasive ventilation for sleep apnea in children with Down syndrome

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• 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

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

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• Multimodal Deep Learning to Predict Sleep Apnea Severity from SpO2 and Ballistocardiography

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• Nightly wearable monitoring with at-home submental electrical stimulation for sleep apnea

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• Functional capacity and muscle function in adults with obstructive sleep apnea

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.