SleepNCT02398214
A Sleep Hygiene-based Intervention Program for Infants and Toddlers
A study testing Sleep hygiene in people with Sleep, run by National Taiwan University Hospital at 1 site in Taiwan.
Trial summary
Sleep problems during infancy are associated with behavior and emotional problems, poor language development , parental distress and mood disturbances, and overweight and obese children. Read more about this study
- Who is it for?
- Ages 6 months to 2 yearsHealthy volunteers can take part
- Conditions the study is for
- Sleep
- What is being tested?
- Sleep hygiene
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 247 participants
- Where
- 1 siteTaiwan
- Study dates
- Nov 2012to Dec 2016
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 6 months to 2 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Healthy singleton infant born at gestational age >= 37 weeks
Who cannot join
- Infants born before 37 weeks gestation
- Infants born with a congenital abnormality or a genetic disorder
- Parents with insufficient Chinese
Trial locations and contacts
1 site in 1 country.
About this study
Sleep problems during infancy are associated with behavior and emotional problems, poor language development , parental distress and mood disturbances, and overweight and obese children. The investigators proposed that children who receive the light, activity, and sleep training (LAST) intervention program in this study will have less parent report of problem sleep behaviors and longer duration of nighttime sleep compared to children with no intervention provided.
Read the detailed description
Sleep problems are reported in 71.65% of our nation's infants and toddlers, and the prevalence is much higher than the 20-30% reported in Western countries. The investigators' preliminary findings also show that approximately 53-55% of parents of children between 6 and 12 months of age consider their child sleep a problem with about 4% not knowing whether their child sleep is a problem. Sleep development during infancy is characterized by increasing day-night differences in sleep-wakefulness such as longer bouts of sleep and fewer awakenings at night, and is driven by neurobiological maturation and environmental interactions. By 3 months of age, nearly 58% of infants can sleep continuously between 24:00-05:00 hours. When infants do not sleep through the night by 17 months of age, they are less likely to be able to do so at 29 months of age and beyond. Without proper intervention, sleep problems during infancy can persist to toddler and preschool age. Various interventions have been developed and tested in Western and Asian Countries to address the sleep problems in infants and young children, but none are in Taiwan.
- Conditions
- Sleep
- Being tested
- Sleep hygiene
- Keywords
- Sleep, Infants, Toddlers, Behavioral intervention
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Sleep hygieneBehavioural
LAST intervention (light, activity, and sleep training) consists of behavioral and educational strategies for increasing light exposure and physical activity, minimizing television viewing and reducing television viewing time to < 2 hours per day, and engaging activities suitable to the child's motor development to minimize sleep disturbance.
| Study group | Role | What they receive |
|---|---|---|
| Sleep hygiene & standard care | Experimental | Participants receive a light, activity, and sleep training (LAST) intervention consists of behavioral and educational strategies for increasing light exposure and physical activity to minimize sleep disturbance. Receives: Behavioral: Sleep hygiene |
| Standard care | No intervention | Participants receive usual care. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Actigraphic assessed sleep quantity variables
Total nighttime, daytime, and 24 hour sleep duration
Measured: Baseline, 6-month follow-up, 12-month follow-up, and 18-month follow-up
Secondary outcomes (1)
Actigraphic assessed sleep quality variables
Sleep onset latency and wake after sleep onset
Measured: Baseline, 6-month follow-up, 12-month follow-up, and 18-month follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Mar 2015 (estimated)
- Study startNov 2012
- Primary completionDec 2016
- Study completionDec 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for SleepStudies of the same condition, open and under way.
- More trials run by National Taiwan University HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 247 participants (actual)
Sponsor and investigators
- Lead sponsor
- National Taiwan University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Shao-Yu Tsai, PhD, Principal investigator, National Taiwan University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02398214
- Sponsor's protocol ID
- 201203083RIC
- Status last verified
- Oct 2016
- First submitted
- 8 Mar 2015
- Last updated
- 18 Apr 2017
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Apr 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Sleep Hygiene-based Intervention Program for Infants and Toddlers
- ClinicalTrials.gov ID
- NCT02398214
- Acronym / sponsor ID
- 201203083RIC
- Conditions
- Sleep
- Keywords
- Sleep, Infants, Toddlers, Behavioral intervention
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 247 participants (actual)
- Lead sponsor
- National Taiwan University HospitalUniversity, hospital or other
- Study start
- Nov 2012
- Primary completion
- Dec 2016 (actual)
- Study completion
- Dec 2016 (actual)
- First posted
- 25 Mar 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Sleep problems during infancy are associated with behavior and emotional problems, poor language development , parental distress and mood disturbances, and overweight and obese children. The investigators proposed that children who receive the light, activity, and sleep training (LAST) intervention program in this study will have less parent report of problem sleep behaviors and longer duration of nighttime sleep compared to children with no intervention provided.
Detailed description
Sleep problems are reported in 71.65% of our nation's infants and toddlers, and the prevalence is much higher than the 20-30% reported in Western countries. The investigators' preliminary findings also show that approximately 53-55% of parents of children between 6 and 12 months of age consider their child sleep a problem with about 4% not knowing whether their child sleep is a problem. Sleep development during infancy is characterized by increasing day-night differences in sleep-wakefulness such as longer bouts of sleep and fewer awakenings at night, and is driven by neurobiological maturation and environmental interactions. By 3 months of age, nearly 58% of infants can sleep continuously between 24:00-05:00 hours. When infants do not sleep through the night by 17 months of age, they are less likely to be able to do so at 29 months of age and beyond. Without proper intervention, sleep problems during infancy can persist to toddler and preschool age. Various interventions have been developed and tested in Western and Asian Countries to address the sleep problems in infants and young children, but none are in Taiwan.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Sleep hygiene & standard care | Experimental | Behavioral: Sleep hygieneParticipants receive a light, activity, and sleep training (LAST) intervention consists of behavioral and educational strategies for increasing light exposure and physical activity to minimize sleep disturbance. |
| Standard care | No intervention | –Participants receive usual care. |
Who may qualify
- Ages
- 6 months to 2 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (1 listed)
- Healthy singleton infant born at gestational age >= 37 weeks
Key exclusion criteria (3 listed)
- Infants born before 37 weeks gestation
- Infants born with a congenital abnormality or a genetic disorder
- Parents with insufficient Chinese
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Sleep hygieneLAST intervention (light, activity, and sleep training) consists of behavioral and educational strategies for increasing light exposure and physical activity, minimizing television viewing and reducing television viewing time to < 2 hours per day, and engaging activities suitable to the child's motor development to minimize sleep disturbance. | Behavioural | Sleep hygiene & standard care |
Primary outcome
Actigraphic assessed sleep quantity variables
Time frame: Baseline, 6-month follow-up, 12-month follow-up, and 18-month follow-up
Total nighttime, daytime, and 24 hour sleep duration
1 secondary outcome
Actigraphic assessed sleep quality variables
Time frame: Baseline, 6-month follow-up, 12-month follow-up, and 18-month follow-up
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Apr 2017.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Shao-Yu Tsai, PhD principal investigator
National Taiwan University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Sleep hygiene in people with Sleep, run by National Taiwan University Hospital at 1 site in Taiwan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 18 Apr 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Actigraphic assessed sleep quantity variables (time frame: Baseline, 6-month follow-up, 12-month follow-up, and 18-month follow-up). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Apr 2017.