Condition category
Genetic Diseases
Date applied
13/04/2018
Date assigned
22/05/2018
Last edited
02/05/2018
Prospective/Retrospective
Prospectively registered
Overall trial status
Ongoing
Recruitment status
Recruiting

Plain English Summary

Background and study aims
Children with Down syndrome (a genetic condition typically causing some level of learning disability) experience sleep problems more often than typically-developing children. Untreated, this can lead to sleepiness, behavioural/emotional problems, cognitive impairment and reduced quality of life. Children’s sleep problems also affect parental wellbeing, and parents caring for a child with a developmental disability may already experience poor sleep.
This study aims to test the effect of a sleep education package on the sleep and quality of life of young children (aged 6 months - 5 years) with Down syndrome and their parents/carers.

Who can participate?
Child aged 0.5-5 years with down syndrome and parent/carer

What does the study involve?
Participating children and their parents/carers are randomly allocated to one of two groups. Those in the first group receive the education package (intervention group) which includes a short film, colour booklet and talk, all of which include basic information on sleep and good sleep practices. It is delivered in a small group setting in venues across Scotland.
Those in the second group receive a short talk on another topic (control group).
Sleepiness, behaviour and quality of life of children and parents/carers is assessed using questionnaires at the start of the study and at 4 weeks, 6 month and 12 month follow-up visits. Sleep quality will be measured using a wrist-worn device called an actigraph, again at 4 week, 6 month and 12 month intervals.
Participants in the control group are offered the education package at the end of the study, with 4 week, 6 month and 12 month follow-up if they wish.

What are the possible benefits and risks of participating?
All parents and carers receive the study education package which may help prevent or improve sleep problems in the children taking part. If it is shown to be effective, it will be made freely available to help other children with Down syndrome and their families. At the end of the study, participants receive feedback on their child’s study data, including detailed information on their child’s sleep/wake patterns as measured using the actigraph. All children taking part in the study receive screening for breathing problems during sleep, meaning that these problems may be identified and treated earlier and potentially prevent longer- term health issues.
Possible disadvantages: Participants are enrolled in the study for a maximum of 15 months, during which time they are expected to attend 8 visits. This may involve travelling some distance from their home, although we aim to minimise this by offering locations across Scotland. Reasonable travel expenses are paid during the study period. Participants are required to return some equipment by post, however, the study team cover Royal Mail postage costs for this. The education pack includes some techniques to improve sleep which require commitment and persistence by the parent. Some families may find this challenging but the study team provides support and guidance. It is possible that we may discover a significant sleep disorder during study testing. In this case, we inform the parent/carer and also contact the child’s GP.

Where is the study run from?
Royal Hospital for Sick Children (UK)

When is the study starting and how long is it expected to run for?
November 2016 to January 2020

Who is funding the study?
Edinburgh Children’s Hospital Charity (UK)

Who is the main contact?
Dr Lizzie Hill
lizzie.hill@nhs.net, +44 (0)131 242 9382

Trial website

Contact information

Type

Public

Primary contact

Dr Elizabeth (Lizzie) Hill

ORCID ID

http://orcid.org/0000-0002-9290-9734

Contact details

Department of Paediatric Cardiac
Respiratory & Sleep Physiology
Royal Hospital for Sick Children
9 Sciennes Road
Edinburgh
EH9 1LF
United Kingdom
+44131 242 9379
lizzie.hill@nhs.net

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

V1.0

Study information

Scientific title

A randomised, parallel groups evaluation of a parental group sleep education intervention in young children with Down syndrome: The REST-Ed study

Acronym

REST-Ed

Study hypothesis

Research questions:
1. Does a parental group education package improve sleep and quality of life for young children with Down syndrome?
2. Does a parental group education package improve sleep and quality of life for the parents of young children with Down syndrome?

Ethics approval

Not provided at time of registration – submission pending

Study design

Single-centre randomised design

Primary study design

Interventional

Secondary study design

Randomised parallel trial

Trial setting

Community

Trial type

Prevention

Patient information sheet

Condition

Down syndrome; Sleep disorders

Intervention

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 during sleep. If a sleep breathing problem is found, the child leaves the research study and is sent for further assessment and treatment locally.
The parents of the remaining children are chosen at random using balanced blocks to receive the education package (intervention group) or a short talk on another non-sleep-related topic (control group).
The intervention is a sleep education package, based on the package evaluated by Stores & Stores (Stores, R. and Stores, G. (2004), Evaluation of Brief Group-Administered Instruction for Parents to Prevent or Minimize Sleep Problems in Young Children with Down Syndrome). This study evaluates a modified version of the Stores and Stores package, including a DVD, booklet and talk delivered in a small-group setting.
Sleepiness, behaviour and quality of life of children and parents/carers is assessed using questionnaires at the start of the study and at 1 month, 6 month and 12 month follow-up visits. Sleep quality is measured using a wrist-worn device called an actigraph, again at 1, 6 and 12 month intervals.
Participants in the control group are offered the education package at the end of the study, with 1 month follow-up if they wish.

Intervention type

Behavioural

Phase

Drug names

Primary outcome measure

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 outcome measures

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

Overall trial start date

21/11/2016

Overall trial end date

01/01/2020

Reason abandoned (if study stopped)

Eligibility

Participant inclusion criteria

Inclusion criteria:
1. Child has known diagnosis of Down syndrome (trisomy 21, mosaic or translocation karyotype)
2. Child aged 0.5 - 5.0yr at baseline visit
3. Child and parent/carer resident in Scotland for the study duration
4. Parent able and willing to comply with protocol

Participant type

Mixed

Age group

Mixed

Gender

Both

Target number of participants

60 (30 per group)

Participant 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

Recruitment start date

01/06/2018

Recruitment end date

01/06/2019

Locations

Countries of recruitment

United Kingdom

Trial participating centre

Department of Paediatric Cardiac, Respiratory and Sleep Physiology
Royal Hospital for Sick Children 9 Sciennes Road
Edinburgh
EH9 1LF
United Kingdom

Sponsor information

Organisation

Academic and Clinical Central Office for Research and Development (ACCORD)

Sponsor details

The Queen's Medical Research Institute
47 Little France Crescent
Edinburgh
EH16 4TJ
United Kingdom

Sponsor type

Other

Website

http://accord.scot/

Funders

Funder type

Charity

Funder name

Edinburgh Children's Hospital Charity (ECHC)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Abstract based on study design accepted for poster presentation at World Down Syndrome Congress, Glasgow 24-27/07/2018.
Abstract submitted for poster/oral presentation at European Sleep Research Society Congress, Basel 25-28/09/2018, to include interim results if available.
Abstracts based on interim results may be submitted to other international conferences in due course, e.g. ERS/ESRS Sleep and Breathing 2019, British Sleep Society Scientific Meeting 2019.
It is anticipated that the final study results will be published in a high-impact, peer-reviewed journal thereafter.

IPD sharing statement:
The datasets generated during and/or analysed during the current study are/will be available upon request from:
Dr Lizzie Hill
Specialist Sleep Clinical Physiologist & NRS Career Research Fellow, NHS Lothian
Sleep Research Fellow, The University of Edinburgh
Department of Paediatric Cardiac, Respiratory & Sleep Physiology
Royal Hospital for Sick Children
9 Sciennes Road
Edinburgh EH9 1LF
Email: lizzie.hill@nhs.net / lizzie.hill@ed.ac.uk
Phone: 0131 536 0643 / 0131 242 9379

Intention to publish date

01/01/2021

Participant level data

Available on request

Basic results (scientific)

Publication list

Publication citations

Additional files

Editorial Notes