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

NCT06030349 · Status: RECRUITING · Type: OBSERVATIONAL · Enrollment: 200

Last updated 2024-02-12

No results posted yet for this study

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.

Conditions

Interventions

DEVICE

Non-invasive ventilation

Non-invasive ventilation

Sponsors & Collaborators

  • University of Edinburgh

    collaborator OTHER

  • Birmingham Children's Hospital

    collaborator OTHER

  • Belfast Health and Social Care Trust

    collaborator OTHER

  • University Hospital Southampton NHS Foundation Trust

    collaborator OTHER

  • University of Dublin, Trinity College

    collaborator OTHER

  • Children's Health Ireland

    lead OTHER_GOV

Principal Investigators

  • Sheila Javadpour · Children's Health Ireland

Eligibility

Min Age
6 Months
Max Age
16 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-11-28
Primary Completion
2027-11-28
Completion
2027-12-28

Countries

  • Ireland
  • United Kingdom

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06030349 on ClinicalTrials.gov