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

Официальное название

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

Обзор

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.

Подробное описание

Our aim is to examine the impact of non-invasive ventilation for treatment of obstructive sleep apnoea syndrome in children with Down Syndrome on behavioural and quality of life outcomes and to establish the specific barriers experienced in establishing adherence to treatment.

Information from clinical assessment, sleep studies and device downloads recorded as part of standard care will be combined with questionnaire data to assess for changes in behaviour and quality of life. All participants will undergo questionnaire assessment of barriers experienced. A sub-group of up to 20 participants will be invited to take part in 45-60 minute semi-structured interviews exploring expectations, experiences and barriers encountered.

Вмешательства

• Устройство Non-invasive ventilation
  Non-invasive ventilation

Первичные конечные точки

• To determine the effect of treatment of obstructive sleep apnoea syndrome with non-invasive ventilation on quality of life in children with Down Syndrome > 3 years. [Срок оценки: Prior to and following 8 weeks attempted initiation of non-invasive ventilation treatment]
• To determine the effect of treatment of obstructive sleep apnoea syndrome with non-invasive ventilation on quality of life in children with Down Syndrome < 3 years. [Срок оценки: Prior to and following 8 weeks attempted initiation of non-invasive ventilation treatment]
• To determine the effect of treatment of obstructive sleep apnoea syndrome with non-invasive ventilation on caregiver concerns regarding sleep disordered breathing for caregivers of children with Down Syndrome < 3 years. [Срок оценки: Prior to and following 8 weeks attempted initiation of non-invasive ventilation treatment]
• To determine the effect of treatment of obstructive sleep apnoea with non-invasive ventilation on sleep behaviours in children with Down Syndrome > 3 years. [Срок оценки: Prior to and following 8 weeks attempted initiation of non-invasive ventilation treatment]
• To determine the effect of treatment of obstructive sleep apnoea with non-invasive ventilation on sleep behaviours in children with Down Syndrome < 3 years. [Срок оценки: Prior to and following 8 weeks attempted initiation of non-invasive ventilation treatment]
• To establish the specific barriers to adherence faced by children > 3 years with Down Syndrome and their caregivers when starting non-invasive ventilation for the treatment of obstructive sleep apnoea syndrome [Срок оценки: Prior to and following 8 weeks attempted initiation of non-invasive ventilation treatment]
• To establish the specific barriers to adherence faced by children < 3 years with Down Syndrome and their caregivers when starting non-invasive ventilation for the treatment of obstructive sleep apnoea syndrome [Срок оценки: Prior to and following 8 weeks attempted initiation of non-invasive ventilation treatment]
• Assessment of expectations, experiences and barriers experienced by families in the treatment of obstructive sleep apnoea syndrome with non-invasive ventilation [Срок оценки: After 8 weeks of attempted initiation of non-invasive ventilation]

Критерии участия

Критерии включения

• 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.

Критерии исключения

• 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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Модель наблюдения

Когортное

Центры проведения

Великобритания · 4 центра

• Royal Belfast Hospital for Sick Children — Belfast
• Birmingham Children's Hospital — Birmingham
• Royal Hospital for Children & Young People — Edinburgh
• Southampton Children's Hospital — Southampton

Ирландия · 2 центра

• Trinity College Dublin — Dublin
• Children's Health Ireland — Dublin

Идентификаторы

NCT: NCT06030349 · REC137-22

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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