Case studies on whether the 'Sleep on number 1' intervention leads to better sleep quality in children aged 0-2
| ISRCTN | ISRCTN16268320 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN16268320 |
| Secondary identifying numbers | 555002012 |
- Submission date
- 21/02/2024
- Registration date
- 21/02/2024
- Last edited
- 04/04/2025
- Recruitment status
- Recruiting
- Overall study status
- Ongoing
- Condition category
- Mental and Behavioural Disorders
Plain English summary of protocol
Background and study aims
Sleep problems are common in young children (0 - 2 years old) and parents often have difficulties managing their infant’s sleep. This study investigates whether the ‘Sleep on number 1!’ intervention improves sleep quality in children.
Who can participate?
Participants are mainly recruited from the participants of the sleep-monitoring study, a bigger study registered under number ISRCTN27246394. Participants can enter the study when they are adult mothers (or fathers/other primary caregivers) of healthy born newborns. To be able to enter the study, the parent’s child has to be healthy, born at term (37 weeks of pregnancy or later), from a singleton birth and not diagnosed with a sleeping disorder or excessive crying. Furthermore, the child may not have a serious medical condition that impedes their sleep or wakefulness, or receive medication that impacts their sleep or wakefulness (such as melatonin). The parent of the child may not receive care from the VoorZorg program: a special Youth Health Care program for vulnerable mothers. For the N-of-1 study parents of 40 children between 3 and 20 months from various ages and various backgrounds will be recruited.
What does the study involve?
The child’s sleep is measured during at least 30 days with an Emfit sleep monitor. Then, the part of the ‘Sleep on number 1! Intervention that is relevant for the age of the child and/or that is relevant because the parents are experiencing a problem with the sleep of the child will be provided to the parent. During the intervention and at least 30 days after the intervention the child’s sleep is again measured by the Emfit sleep monitor.
What are the possible benefits and risks of participating?
Possible benefits of this study are that parents may learn better to manage their infant’s sleep and reduce and prevent infant sleep problems. Risks of participation are very unlikely.
Where is the study run from?
Maastricht University (The Netherlands)
When is the study starting and how long is it expected to run for?
June 2020 to March 2026
Who is funding the study?
ZonMw (The Netherlands)
Who is the main contact?
Dr Ree Meertens, r.meertens@maastrichtuniversity.nl
Contact information
Public, Scientific, Principal Investigator
Department of Health Promotion NUTRIM School of Nutrition and Translational Research in Metabolism
Maastricht University
Maastricht
6200 MD
Netherlands
 ORCID ID |
0000-0001-8424-9142 |
|---|---|
| Phone | +31 (0)43 3882407 |
| r.meertens@maastrichtuniversity.nl |
Study information
| Study design | Series of interventional N-of-1 studies, with at least 30 measurements before and after the intervention |
|---|---|
| Primary study design | Interventional |
| Secondary study design | N-of-1 study |
| Study setting(s) | Home |
| Study type | Prevention |
| Participant information sheet | Not available in web format, please use contact details to request a participant information sheet |
| Scientific title | Evaluation of the 'Sleep on number 1'' intervention in 0-2-year-olds: a series of N-of-1 studies |
| Study acronym | Sleep on number 1; N-of-1 |
| Study objectives | The ‘Sleep on number 1!’ intervention will lead to an improvement in sleep quality in children aged 0-2. |
| Ethics approval(s) |
Approved 31/01/2022, Faculty of Health Medicine and Life Sciences Research Ethical Committee (FHML-REC) (FHML-REC (Department HES), Maastricht University, PO Box 616, Maastricht, 6200 MD, Netherlands; +31 (0)616333110; fhml-rec@maastrichtuniversity.nl), ref: FHML-REC/2022/011 |
| Health condition(s) or problem(s) studied | Sleep problems in children aged 0-2 |
| Intervention | The intervention consists of an age-tailored digital newsletter on infant sleep and crying and/ or a consultation with a trained (YHC) sleep expert who gives advice with the help of 'Sleep on number 1' conversation cards on a problem parents experience. The time that it takes to provide the intervention to the parents may last from 1 day (e.g. only providing an age-tailored newsletter with oral explanation) to a few weeks (e.g. when a home visit or a visit to the Youth Health Care centre needs to be scheduled), dependent on the needs of the parents. |
| Intervention type | Behavioural |
| Primary outcome measure | Sleep quality, defined as the number and duration of nighttime awakenings, measured by a sleep monitoring device (Emfit QS) every night for at least 30 days before the intervention, every night during the intervention, and every night for at least 30 days after the intervention. |
| Secondary outcome measures | 1. Bedtime regularity, as measured by a sleep monitoring device (Emfit QS) during day- and night-time for at least 30 days before the intervention, during day- and night-time during the intervention, and during day- and night-time for at least 30 days after the intervention. 2. Nighttime sleep duration, as measured by a sleep monitoring device (Emfit QS) during night-time for at least 30 days before the intervention, during nighttime during the intervention, and during nighttime for at least 30 days after the intervention. 3. Daytime sleep duration, as measured by a sleep monitoring device (Emfit QS) during daytime for at least 30 days before the intervention, during daytime during the intervention, and during daytime for at least 30 days after the intervention. 4. Time to sleep onset, as measured by a sleep monitoring device (Emfit QS) during day- and night-time for at least 30 days before the intervention, during day- and night-time during the intervention, and during day- and night-time for at least 30 days after the intervention. |
| Overall study start date | 01/06/2020 |
| Completion date | 01/03/2026 |
Eligibility
| Participant type(s) | Healthy volunteer |
|---|---|
| Age group | Child |
| Lower age limit | 3 Months |
| Upper age limit | 24 Months |
| Sex | Both |
| Target number of participants | 40 |
| Key inclusion criteria | Participants are mainly recruited from the participants of the sleep-monitoring study, a bigger study registered under number ISRCTN27246394. From this study and via other channels the researchers will select participants of various ages and backgrounds, who are willing to participate. For the present study participants are recruited when: 1. The child is a healthy newborn of an adult, mentally competent mother (or father/other primary caregiver. 2. The child is 3 to 20 months old at time of recruitment 3. The child has to have access to the intervention, for example by being registered at the local YHC center in one of the intervention regions. |
| Key exclusion criteria | 1. The child is born prematurely (<37 weeks of pregnancy) 2. The child is diagnosed with a sleep disorder (such as pavor nocturnus, iactatio capitis, sleep walking, non-benign sleep myoclonic, obstructive sleep apnea, primary hypersomnia, circadian rhythm disorders, parasomnias, sleep-related movement disorders) 3. The child is diagnosed with excessive crying 4. The child has a serious medical condition that impedes their sleep or wakefulness 5. The child receives medication that impacts their sleep or wakefulness (such as melatonin) 6. The child is part of a multiple birth 7. The parent receives care from the VoorZorg program: a special Youth Health Care program for vulnerable mothers. |
| Date of first enrolment | 01/03/2024 |
| Date of final enrolment | 01/11/2025 |
Locations
Countries of recruitment
- Netherlands
Study participating centres
Venlo
5921 AC
Netherlands
Eindhoven
5611 XP
Netherlands
Sponsor information
Research council
Laan van Nieuw Oost-Indië 334
The Hague
2593 CE
Netherlands
| Phone | +31 (0)70 349 51 11 |
|---|---|
| info@zonmw.nl | |
| Website | http://www.zonmw.nl/en/ |
"ROR" |
https://ror.org/01yaj9a77 |
Funders
Funder type
Research council
Private sector organisation / Other non-profit organizations
- Alternative name(s)
- Netherlands Organisation for Health Research and Development
- Location
- Netherlands
Results and Publications
| Intention to publish date | 01/01/2026 |
|---|---|
| Individual participant data (IPD) Intention to share | Yes |
| IPD sharing plan summary | Stored in non-publicly available repository, Available on request |
| Publication and dissemination plan | The study and study results will be published in national and international peer-reviewed scientific journals (preferably open source journals). |
| IPD sharing plan | The datasets generated during and/or analysed during the study will be stored in a non-publicly available repository (DataHub Maastricht University) and will be available upon request from Ree Meertens (r.meertens@maastrichtuniversity.nl) via Maastricht University. The data will become available for a period of 10 years following publication. Stored data consists of anonymized data. Participants provided informed consent for data collection as well as for data storage and data sharing for future research purposes. Access criteria: non-commercial research. |
Editorial Notes
04/04/2025: The recruitment end date was changed from 01/03/2025 to 01/11/2025. The overall study end date was changed from 01/06/2025 to 01/03/2026.
21/02/2024: Study's existence confirmed by the Faculty of Health Medicine and Life Sciences Research Ethical Committee (FHML-REC).
