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

Quality of Life Clinical Trial

— REFRESHED  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06030349
• Other study ID #: REC137-22
• Status: Recruiting
• Start date: November 28, 2022
• Est. completion date: December 28, 2027

Study information

• Verified date: February 2024
• Source: Children's Health Ireland
• Contact: Roy G Stone
• Phone: 0035314282626
• Email: refreshed[@]olchc.ie
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Description:

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 200
• Est. completion date: December 28, 2027
• Est. primary completion date: November 28, 2027
• Accepts healthy volunteers: No
• Gender: All
• Age group: 6 Months to 16 Years

Eligibility

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.

Related Conditions & MeSH terms

• Adherence, Treatment
• Apnea
• Behavior
• Down Syndrome
• Obstructive Sleep Apnea
• Quality of Life
• Sleep Apnea Syndromes
• Sleep Apnea, Obstructive
• Syndrome

Intervention

Device:
• Non-invasive ventilation
Non-invasive ventilation

Locations

Country	Name	City	State
Ireland	Children's Health Ireland	Dublin
Ireland	Trinity College Dublin	Dublin
United Kingdom	Royal Belfast Hospital for Sick Children	Belfast
United Kingdom	Birmingham Children's Hospital	Birmingham
United Kingdom	Royal Hospital for Children & Young People	Edinburgh
United Kingdom	Southampton Children's Hospital	Southampton

Sponsors (6)

Lead Sponsor	Collaborator
Children's Health Ireland	Belfast Health and Social Care Trust, Birmingham Children's Hospital, University Hospital Southampton NHS Foundation Trust, University of Dublin, Trinity College, University of Edinburgh

Countries where clinical trial is conducted

Ireland,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	Change in Obstructive Sleep Apnoea - 18 scores (Range 0- 126, Higher scores indicating worse quality of life) from baseline will be used to evaluate for improvement in sleep related breathing specific quality of life in children >3 years. Sleep disturbance, physical suffering, emotional distress, daytime problems and caregiver concern subscales will also be evaluated for change.	Prior to and following 8 weeks attempted initiation of non-invasive ventilation treatment
Primary	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.	Change in Infant Toddler Quality of Life - Short Form 47 scores (Range 0 - 100, Higher scores indicating greater quality of life) from baseline will be used to evaluate for improvement in sleep related breathing specific quality of life in children < 3 years. Infant and parent subscales will also be evaluated for change.	Prior to and following 8 weeks attempted initiation of non-invasive ventilation treatment
Primary	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.	Change in Caregiver-concern domain of the Obstructive Sleep Apnoea - 18 (Range 0 - 28, Higher scores indicating worse quality of life) from baseline will be used to evaluate for change in caregiver concern regarding sleep disordered breathing.	Prior to and following 8 weeks attempted initiation of non-invasive ventilation treatment
Primary	To determine the effect of treatment of obstructive sleep apnoea with non-invasive ventilation on sleep behaviours in children with Down Syndrome > 3 years.	Change in Child Sleep Habits Questionnaire scores (Range 0 - 97, Higher scores indicating greater sleeping difficulties) from baseline will be used to evaluate for overall improvement in sleep behaviours in children > 3 years. Bedtime resistance, sleep onset delay, sleep duration, sleep anxiety, night waking, parasomnia, sleep disordered breathing and daytime sleepiness subscales will also be evaluated for change.	Prior to and following 8 weeks attempted initiation of non-invasive ventilation treatment
Primary	To determine the effect of treatment of obstructive sleep apnoea with non-invasive ventilation on sleep behaviours in children with Down Syndrome < 3 years.	Change in Brief Infant Sleep Questionnaire scores (Range 0 - 100, Lower scores indicating greater sleeping difficulties) from baseline will be used to evaluate for overall improvement in sleep behaviours in children < 3 years. Infant sleep, parent perception and parent behaviour subscales will also be evaluated for change.	Prior to and following 8 weeks attempted initiation of non-invasive ventilation treatment
Primary	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	Quantitative assessment of barriers encountered in establishing adherence will be evaluated using the Continuous Positive Airway Pressure Questionnaire (Range 29-145, Higher scores indicating greater barriers to adherence) for children > 3 years. Behaviours/belief/environment, emotional and physical subscales will also be evaluated for change.	Prior to and following 8 weeks attempted initiation of non-invasive ventilation treatment
Primary	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	Quantitative assessment of barriers encountered in establishing adherence will be evaluated using the Modified Continuous Positive Airway Pressure Questionnaire (Range 27 - 135, Higher scores indicating greater barriers to adherence) for children < 3 years. This is a non-validated questionnaire developed by our research group.	Prior to and following 8 weeks attempted initiation of non-invasive ventilation treatment
Primary	Assessment of expectations, experiences and barriers experienced by families in the treatment of obstructive sleep apnoea syndrome with non-invasive ventilation	Qualitative assessment of expectations, experiences and barriers experienced during non-invasive ventilation treatment will be explored through semi-structured interviews to add nuance to the outcomes around efficacy of treatment, quality of life, behaviour, and treatment adherence	After 8 weeks of attempted initiation of non-invasive ventilation