REST-Ed Study V1.0
Research type
Research Study
Full title
The effect of parental group sleep education in young children with Down syndrome: the REST-Ed Study.
IRAS ID
227772
Contact name
Florian Gahleitner
Contact email
Sponsor organisation
NHS Lothian
ISRCTN Number
ISRCTN65197569
Clinicaltrials.gov Identifier
NA, NA
Duration of Study in the UK
3 years, 0 months, 27 days
Research summary
Sleep problems are common in children with Down syndrome (DS). Untreated sleep problems affect the health and wellbeing of children and their parents/carers. These problems can be due to breathing pauses occurring during sleep (sleep apnoea) and/or sleep behaviours that prevent the child from settling or cause them to wake overnight. This study aims to answer the following questions:
1. Can a parent education package (DVD, booklet and group session) improve sleep and quality of life for young children (aged 6 months to 5 years) with DS?2. Can this package improve sleep and quality of life for the carers of young children with DS?
3. What proportion of young children with DS in Scotland have untreated sleep apnoea?
Participating children will have a sleep study at home using to measure breathing overnight. Children found to have significant sleep apnoea will leave the study and will be signposted for further assessment and treatment via the NHS.
The remaining children will be randomly assigned to one of two groups. Both will receive the parent education package in a small group setting, but in a different order to determine whether it makes a difference. Parents/carers will complete short questionnaires to assess sleep and quality of life at the start and at different points during the study. We will also use an activity monitor (called and actigraph) on the child’s wrist or ankle to measure their sleep and wake patterns for 14 days on 4 occasions. A maximum of 8 visits is expected over a period of 15 months at a venue close to the child’s home, where possible. Travel expenses will be refunded.
This research is being conducted by researchers from NHS Lothian and the University of Edinburgh with support from Down’s Syndrome Scotland and funding from the Edinburgh Children’s Hospital Charity.
REC name
East of Scotland Research Ethics Service REC 2
REC reference
19/ES/0058
Date of REC Opinion
25 Jul 2019
REC opinion
Further Information Favourable Opinion