Simple bedtime routine could ease infant insomnia without medication
NCT ID NCT07420504
First seen Jun 27, 2026 · Last updated Jul 10, 2026 · Updated 1 time
Summary
This study tests whether teaching parents a consistent, calming bedtime routine can improve sleep in infants and toddlers diagnosed with behavioral insomnia. Thirty children aged 0-3 years will wear a watch-like device to track sleep quality, and parents will report on sleep patterns and their child's self-regulation. The goal is to see if this non-drug approach can reduce night wakings and improve overall sleep.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- sleep hygiene education and bedtime routine training for parents
- What this could lead to
- If it works, this could provide a simple, drug-free way to improve sleep and self-regulation in young children with behavioral insomnia.
- What could go wrong
- This is a small, early-stage study with only 30 participants, so results may not apply to all children. The intervention relies on parents following the routine consistently, which may be challenging.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Not a phased trial
Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.
- Participants
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About 30 people
The number the study aims to enrol. It can still change while the study runs.
- Expected to start
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Aug 2026
An estimate. Start dates often move.
- Expected to finish
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Aug 2028
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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6 to 36 months
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: 1. Children aged 6-36 months 2. Diagnosed with behavioural insomnia (sleep latency \> 20 minutes and/or ≥ 2 nighttime awakenings per night, each lasting at least 5 minutes) 3. Daytime functional impairment (eg., excessive sleepiness, inattention, emotional problems) 4. Parental consent for participation Exclusion Criteria: 1. Chronic diseases 2. History of head trauma 3. Other primary sleep disorders (e.g., obstructive sleep disorder, narcolepsy, restless leg syndrome) 4. Developmental delay, epilepsy, or other neurological/metabolic disorders 5. Participation in a new intervention program within the past 4 weeks, and/or initiation of new medication within the past 4 weeks.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
1 site. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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Childrens' Hospital of Soochow University
Suzhou, Jiangsu, China