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Updated: Mar 15, 2026

Multi-Modal Home Sleep Monitoring in Older Adults
Published on: January 26, 2019
Infant sleep hygiene counseling (sleep trial): protocol of a randomized controlled trial
Ina S Santos1, Diego G Bassani2, Alicia Matijasevich3
1Postgraduate Program in Epidemiology, Federal University of Pelotas, Rua Marechal Deodoro 1160, 3rd floor, 96220020, Pelotas, RS, Brazil. inasantos@uol.com.br.
Insights
This study introduces a behavioral intervention to improve infant sleep, addressing associated health and developmental issues. Early intervention promotes healthier sleep patterns, crucial for child development and well-being.
Area of Science:
- Pediatric Sleep Medicine
- Behavioral Interventions
- Child Development
Background:
- Childhood sleep problems are linked to cognitive, emotional, and behavioral issues.
- Short sleep duration in children is associated with increased risk of overweight and obesity.
- Infant sleep interventions are crucial for long-term health and development.
Purpose of the Study:
- To describe the protocol for a behavioral intervention designed to promote healthier sleep in infants.
- To evaluate the effectiveness of a standardized sleep advice intervention delivered by trained fieldworkers.
- To assess the impact of improved infant sleep on child growth and neurocognitive development.
Main Methods:
- A 1:1 parallel group, single-blinded randomized controlled trial involving 552 infants at 3 months of age.
- Intervention group mothers received standardized advice, a booklet, daily phone calls, and reinforcement visits.
- Primary outcome: difference in average nighttime self-regulated sleep duration at 6, 12, and 24 months, measured by actigraphy, diaries, and questionnaires.
Main Results:
- The study is designed to assess the between-group differences in infant sleep duration.
- Secondary outcomes include conditional linear growth and neurocognitive development at 12 and 24 months.
- Actigraphy, activity diary records, and questionnaires will be used for outcome assessment.
Conclusions:
- Inadequate sleep negatively impacts children's physical, mental, and cognitive health, with higher risks in low- and middle-income countries.
- Inexpensive, accessible behavioral interventions targeting mothers and infants can prevent future health and developmental issues.
- Early, targeted sleep interventions are vital for mitigating risks associated with insufficient sleep in early childhood.
Background:
Sleep problems in childhood have been found to be associated with memory and learning impairments, irritability, difficulties in mood modulation, attention and behavioral problems, hyperactivity and impulsivity. Short sleep duration has been found to be associated with overweight and obesity in childhood. This paper describes the protocol of a behavioral intervention planned to promote healthier sleep in infants.
Methods:
The study is a 1:1 parallel group single-blinded randomized controlled trial enrolling a total of 552 infants at 3 months of age. The main eligibility criterion is maternal report of the infant's sleep lasting on average less than 15 h per 24 h (daytime and nighttime sleep). Following block randomization, trained fieldworkers conduct home visits of the intervention group mothers and provide standardized advice on general practices that promote infant's self-regulated sleep. A booklet with the intervention content to aid the mother in implementing the intervention was developed and is given to the mothers in the intervention arm. In the two days following the home visit the intervention mothers receive daily telephone calls for intervention reinforcement and at day 3 the fieldworkers conduct a reinforcement visit to support mothers' compliance with the intervention. The main outcome assessed is the between group difference in average nighttime self-regulated sleep duration (the maximum amount of time the child stays asleep or awake without awakening the parents), at ages 6, 12 and 24 months, evaluated by means of actigraphy, activity diary records and questionnaires. The secondary outcomes are conditional linear growth between age 3-12 and 12-24 months and neurocognitive development at ages 12 and 24 months.
Discussion:
The negative impact of inadequate and insufficient sleep on children's physical and mental health are unquestionable, as well as its impact on cognitive function, academic performance and behavior, all of these being factors to which children in low- and middle-income countries are at higher risk. Behavioral interventions targeting mothers and young children that can be delivered inexpensively and not requiring specialized training can help prevent future issues by reducing the risk to which these children are exposed.
Trial Registration:
ClinicalTrial.gov NCT02788630 registered on 14 June 2016 (retrospectively registered).
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