Down syndrome
Conditions
Interventions
Parents /carers of children aged 6 months - 5 years with Down Syndrome living in Scotland are invited to take part. All children taking part have a sleep study at home to test for breathing problems d
Sponsors
Academic and Clinical Central Office for Research and Development (ACCORD)
Eligibility
Sex/Gender
All
Age
0.5 Years to 5 Years
Inclusion criteria
Inclusion criteria: 1. Child has known diagnosis of Down syndrome (trisomy 21, mosaic or translocation karyotype) 2. Child aged 0.5 - 5.0 years at baseline visit 3. Child and parent/carer resident in Scotland for the study duration 4. Parent able and willing to comply with protocol
Exclusion criteria
Exclusion criteria: 1. Child has a previous diagnosis of sleep-disordered breathing (SDB), whether treated or untreated, or evidence of SDB on home cardio-respiratory polygraphy at screening (children showing evidence of SDB at screening will be signposted for further assessment/treatment as required via their local NHS pathway) 2. Child has severe or uncontrolled comorbidities affecting sleep or ability to participate, e.g. uncontrolled epilepsy, chronic lung disease, uncorrected congenital heart defects 3. Child is currently using medication which may affect sleep, e.g. melatonin, sedating antihistamines, benzodiazepines, chloral hydrate etc 4. Child has severe behavioural problems which would preclude compliance with home cardio-respiratory polygraphy or actigraphy 5. Not resident in Scotland for duration of study 6. Parent unable or unwilling to comply with protocol
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1. Sleep disturbance is measured using Composite Sleep Disturbance Score at baseline and 4wk post-intervention. 2. Total sleep time and sleep efficiency are assessed by actigraphy at baseline and 4wk post-intervention. | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Prevalence of sleep-disordered breathing (SDB) is assessed using a sleep study at home at the start of the study 2. Composite sleep score at baseline, 6m and 12m post-intervention 3. Total sleep time and sleep efficiency are assessed by actigraphy at baseline, 6m and 12m post-intervention 4. Child quality of life is measured using Infant and Toddler Quality of Life questionnaire (47-item short form) at baseline, 4wk, 6m and 12m post-intervention 5. Child behaviour is measured using the Child Behaviour Checklist at baseline, 4wk, 6m and 12m post-intervention 6. Parental quality of life is measured using GHQ-12 at baseline, 4wk, 6m and 12m post-intervention 7. Parental sleepiness is measured using pictorial Epworth Sleepiness Scale at baseline, 4wk, 6m and 12m post-intervention | — |
Countries
Scotland, United Kingdom
Contacts
Public ContactElizabeth (Lizzie) Hill
Outcome results
None listed