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Case studies on whether the 'Sleep on number 1' intervention leads to better sleep quality in children aged 0-2

Evaluation of the 'Sleep on number 1'' intervention in 0-2-year-olds: a series of N-of-1 studies

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ISRCTN
Registry ID
ISRCTN16268320
Enrollment
40
Registered
2024-02-21
Start date
2024-03-01
Completion date
Unknown
Last updated
2026-03-30

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Sleep problems in children aged 0-2 Mental and Behavioural Disorders

Interventions

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

Sponsors

Netherlands Organisation for Health Research and Development
Lead Sponsor

Eligibility

Sex/Gender
All
Age
3 Months to 24 Months

Inclusion criteria

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.

Exclusion criteria

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.

Design outcomes

Primary

MeasureTime frame
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

MeasureTime frame
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.

Countries

Netherlands

Contacts

Public ContactRee Meertens
r.meertens@maastrichtuniversity.nl+31 (0)43 3882407

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Apr 4, 2026