Clinical trial NCT05201924: Bedtime Routines and Children's Health
Official title: Bedtime Routines and Health-related Outcomes in School-age Children
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Myopia
Dental Caries
Sleep
Asthenopia
Keywords: Myopia
dental caries
bedtime routine
sleep
Lead sponsor: National Taiwan University
Sponsor class: OTHER
First posted: 2022-01-21
Enrollment: 160
Sex: ALL
Minimum age (years): 6
Maximum age (years): 8
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: An bedtime routine interventional group and a healthy lifestyle control group
Primary purpose: PREVENTION

Brief summary: In Taiwan, the prevalence of sleep problems, myopia, and dental caries in school-age children is high. Little is known regarding the implementation of oral and vision health outcomes around bedtime. A bedtime routine intervention was conducted to improve children's oral, vision and sleep health.

Detailed description: Background: In Taiwan, the prevalence of sleep problems, myopia, and dental caries in school-age children is high. Recent studies show that there are some linkages between sleep, myopia, and dental caries; however, most of the studies were observational studies and lack of interventional studies. In addition, little is known regarding the implementation of oral and vision health outcomes around bedtime. Establishing beneficial bedtime routines is recommended for improving health-related outcomes. Brush-Book-Bed (BBB), a bedtime routine program proposed by the American Academy of Pediatrics, has been widely applied in Western countries as a bedtime guideline. Therefore, in current research, researchers will apply the concept of BBB into practice with primary caregivers with the hope to improve sleep, dental health, and vision health outcomes.

Purpose: To compare the effectiveness of a BBB intervention group to control groups in school-age children.

Method: This study is a pilot interventional study. A total of 200 first graders will be allocated to either the intervention group or the control group. Inclusion criteria include (1) sleep duration less than 9 hours or more than 11 hours (2) average bedtime later than 9:30 p.m. Exclusion criteria include (1) intellectual disability prior to pre-school age diagnosed by physicians (2) special education students (3) less than 15 school day per month (4) medications used that influence sleep (5) congenital eye diseases (6) dental emergencies. Individual permuted block randomization will be used for the assignment. Intervention includes bedtime brushing, limited sugar consumption around bedtime, reading books instead of using screen devices before bed, setting a regular bedtime, turning off the light, and reaching a 9 to 11-hour sleep duration. Researchers will send interactive reminder messages periodically to maintain participants' compliance. Sleep questionnaires include CSHQ, modified Bedtime Routine Questionnaires, a sleep diary, Pediatric Daytime Sleepiness Scale, Questionnaire, Epworth Sleepiness Scale, and The Pittsburgh Sleep Quality Index. Oral hygiene evaluation includes salivary pH value and salivary flow rate. The near vision test and refractive error are evaluated as myopia measurements. Asthenopia pictures and critical flicker fusion frequency are used to measure subjective eye fatigue. Moreover, a self-administered questionnaire related to sleep, oral hygiene, and vision health is also measured. Intervention Feasibility will be asked with open-ended questionnaires immediately after the intervention. Data analyses will be conducted using SPSS Statistics 22.0. The findings of this pilot study will provide the basis for developing a tailored bedtime routine for Taiwanese children. which can be applied in further interventional studies. In addition, outcome indicators can act as proxies, early detection if potential risks of sleep problems, and vision or oral diseases.

Estimated Result: School-age children who receive BBB intervention will have significantly better health-related outcomes than those without after the intervention, the third and sixth months post-intervention.

Eligibility criteria: Inclusion Criteria:

1. Children whose average bedtime later than 9:30 pm
2. Children who sleep less than 9 hours or more than 11 hours

Exclusion Criteria:

1. intellectual disability prior to pre-school age diagnosed by physicians
2. special education students
3. less than 15 school day per month
4. medications used that influence sleep
5. congenital eye diseases
6. dental emergencies

Primary outcomes:
measure: the change of bedtime activities and sleep patterns
timeFrame: 7 days at baseline, three month post intervention and six month post intervention
measure: the change of bedtime routines
timeFrame: baseline, three month post intervention and six month post intervention
measure: the change of children's sleep habits
timeFrame: three month post intervention and six month post intervention
measure: The change of caregiver's sleep quality
timeFrame: baseline, three month post intervention and six month post intervention
measure: The change of caregiver's daytime sleepiness
timeFrame: baseline, three month post intervention and six month post intervention
measure: The change of pediatric daytime sleepiness
timeFrame: baseline, three month post intervention and six month post intervention
Secondary outcomes:
measure: the change of myopia
timeFrame: baseline, three month post intervention and six month post intervention
measure: the change of stereopsis
timeFrame: baseline, three month post intervention and six month post intervention
measure: the change of objective Asthenopia
timeFrame: baseline, three month post intervention and six month post intervention
measure: the change of subjective Asthnopia
timeFrame: baseline, three month post intervention and six month post intervention
measure: the change of oral pH
timeFrame: baseline, three month post intervention and six month post intervention; before bedtime after brushing and rising time before brushing
measure: the change of salivary flow rate
timeFrame: baseline, three month post intervention and six month post intervention
measure: the change of health-related cognition
timeFrame: baseline, three month post intervention and six month post intervention
Other outcomes:
Locations:
city: Taipei
country: Taiwan
facility: Tsai, Han-Yi
Study officials:
References: