The effect of parental group sleep education in young children with Down syndrome: The REST-Ed study
| ISRCTN | ISRCTN65197569 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN65197569 |
| IRAS number | 227772 |
- Submission date
- 13/04/2018
- Registration date
- 22/05/2018
- Last edited
- 26/02/2025
- Recruitment status
- Stopped
- Overall study status
- Stopped
- Condition category
- Genetic Diseases
Plain English summary of protocol
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 June 2025
Who is funding the study?
Edinburgh Children’s Hospital Charity (UK)
Who is the main contact?
Dr Florian Gahleitner
Florian.Gahleitner@nhslothian.scot.nhs.uk
Contact information
Principal Investigator
Department of Paediatric Respiratory and Sleep Physiology
Royal Hospital for Children and Young People
50 Little France Crescent
Edinburgh
EH16 4TJ
United Kingdom
| Phone | +44 131 312 0398 |
|---|---|
| Florian.Gahleitner@nhslothian.scot.nhs.uk |
Public
Sleep & Circadian Neuroscience Institute
Nuffield Department of Clinical Neurosciences
University of Oxford
New Biochemistry Building
South Parks Road
Oxford
OX1 3QU
United Kingdom
 ORCID ID |
0000-0002-9290-9734 |
|---|---|
| Phone | +44131 242 9379 |
| lizzie.hill@uwe.ac.uk |
Study information
| Study design | Single-centre randomized design |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised parallel trial |
| Study setting(s) | Community |
| Study type | Prevention |
| Participant information sheet | Not available in web format, please use the contact details to request a patient information sheet. |
| Scientific title | A randomised, parallel groups evaluation of a parental group sleep education intervention in young children with Down syndrome: The REST-Ed study |
| Study acronym | REST-Ed |
| Study objectives | 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(s) | Approved 25/07/2019, East of Scotland Research Ethics Service (Tayside Academic Health Sciences Centre, Residency Block Level 3, George Pirie Way, Ninewells Hospital& Medical School, Dundee, DD1 9SY, UK; +44 (0)1382 383848; TAY.eosres@nhs.scot), REC ref: 19/ES/0058 |
| Health condition(s) or problem(s) studied | 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 |
| 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 study start date | 21/11/2016 |
| Completion date | 30/06/2025 |
| Reason abandoned (if study stopped) | Participant recruitment issue |
Eligibility
| Participant type(s) | Mixed |
|---|---|
| Age group | Mixed |
| Lower age limit | 0.5 Years |
| Upper age limit | 5 Years |
| Sex | Both |
| Target number of participants | 60 (30 per group) |
| Total final enrolment | 13 |
| Key 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 |
| Key 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 |
| Date of first enrolment | 01/03/2022 |
| Date of final enrolment | 28/02/2025 |
Locations
Countries of recruitment
- Scotland
- United Kingdom
Study participating centre
50 Little France Crescent
Edinburgh
EH16 4TJ
United Kingdom
Sponsor information
Other
The Queen's Medical Research Institute
47 Little France Crescent
Edinburgh
EH16 4TJ
United Kingdom
| Website | http://accord.scot/ |
|---|---|
"ROR" |
https://ror.org/01x6s1m65 |
Funders
Funder type
Charity
No information available
Results and Publications
| Intention to publish date | 30/06/2025 |
|---|---|
| Individual participant data (IPD) Intention to share | Yes |
| IPD sharing plan summary | Available on request |
| 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 plan | The datasets generated during and/or analysed during the current study are/will be available upon request from: Dr Florian Gahleitner Primary Investigator Florian.Gahleitner@nhslothian.scot.nhs.uk |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| HRA research summary | 28/06/2023 | No | No |
Editorial Notes
26/02/2025: The following changes were made to the trial record:
1. The study was stopped due to poor recruitment.
2. The total final enrolment was added (13 participants had been enrolled, 3 participants were excluded following screening sleep study, 1 participant dropped out (uncontactable) after sleep study, 7 participants completed the whole study).
29/02/2024: Contact details updated.
14/12/2023: The following changes were made to the trial record:
1. The recruitment end date was changed from 31/12/2023 to 28/02/2025.
2. The overall end date was changed from 31/12/2024 to 30/06/2025.
3. The intention to publish date was changed from 31/12/2024 to 30/06/2025.
4. The plain English summary was updated to reflect these changes.
05/04/2022: The study contact has been updated.
23/03/2022: The recruitment end date has been changed from 31/12/2022 to 31/12/2023.
16/02/2022: The following changes were made to the trial record:
1. A principal investigator contact was added.
2. The overall end date was changed from 01/06/2023 to 31/12/2024.
3. The recruitment start date was changed from 01/06/2018 to 01/03/2022.
4. The recruitment end date was changed from 01/06/2019 to 31/12/2022.
5. The intention to publish date was changed from 01/01/2024 to 31/12/2024.
6. The plain English summary was updated to reflect these changes.
14/02/2022: Ethics approval details and IRAS Project ID added.
04/06/2021: The following changes have been made:
1. The overall trial end date has been changed from 01/01/2020 to 01/06/2023 and the plain English summary has been updated to reflect this change.
2. The intention to publish date has been changed from 01/01/2021 to 01/01/2024.
25/05/2021: Proactive update review.
