An interventional study of Bedtime routine and Control in Myopia, Dental Caries and Sleep, sponsored by National Taiwan University. Completed at 1 site in Taiwan. Open to participants aged 6 Years to 8 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2024-11-27.
Sponsored by National Taiwan University · Not applicable, Interventional, and Prevention
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.
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.
1,159 studies on the registry are indexed under Myopia; 225 are open to participants now.
This study's enrollment of 160 is above the median of 78 across 923 interventional studies indexed under Myopia.
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Exclusion Criteria:
A bedtime routine intervention handbook and check list, including 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
Behavioral: Bedtime routine
healthy lifestyle checklist
Behavioral: Control
a regular routine conducted around bedtime includes brush, book reading and regular bedtime
a healthy control checklist
the change of bedtime activities and sleep patterns
self-administered sleep diary, including sleep patterns, screen device use 2 hours before bedtime, caffine food intake
Time frame: 7 days at baseline, three month post intervention and six month post intervention
the change of bedtime routines
Bedtime routine questionnaire (Handerson \& Jordan, 2010): the subscale of bedtime consistency and bedtime adaptive activities
Time frame: baseline, three month post intervention and six month post intervention
the change of children's sleep habits
Children's sleep habits questionnaire, CSHQ (Owens et al., 2000). Higher score means more disturbed sleep. The internal consistency for both the community sample was 0.68; alpha coefficients for the various subscales of the CSHQ ranged from 0.36 (Parasomnias) to 0.70 (Bedtime Resistance) for the community sample. Test-retest reliability was acceptable (range 0.62 to 0.79).
Time frame: three month post intervention and six month post intervention
The change of caregiver's sleep quality
Pittsburgh Sleep Quality Index, PSQI (Buysse et al., 1989). The global PSQI score greater than 5 yielded a diagnostic sensitivity of 89.6% and specificity of 86.5% (kappa = 0.75, p less than 0.001) in distinguishing good and poor sleepers.
Time frame: baseline, three month post intervention and six month post intervention
The change of caregiver's daytime sleepiness
Epworth Sleepiness Scale, ESS (Johns et al., 1991). The internal consistency as measured by Cronbach's alpha was 0.88. Higher scores means more daytimes sleepiness.
Time frame: baseline, three month post intervention and six month post intervention
The change of pediatric daytime sleepiness
Pediatric Daytime Sleepiness (Drake et al., 2003). Scores ranged from 0 to 32. Mean score values in the original study were 15.3 ± 6.2. Higher scores indicate greater sleepiness.
Time frame: baseline, three month post intervention and six month post intervention
the change of myopia
near vision eye chart
Time frame: baseline, three month post intervention and six month post intervention
the change of stereopsis
stereo book
Time frame: baseline, three month post intervention and six month post intervention
the change of objective Asthenopia
handy flicker for critical fusion frequency test. Normal CFF ranged between 30 to 50 Hz
Time frame: baseline, three month post intervention and six month post intervention
the change of subjective Asthnopia
self-administered pictures for eye symptoms. Higher score means more eye fatigue.
Time frame: baseline, three month post intervention and six month post intervention
the change of oral pH
pH values was tested using MACHEREY-NAGEL pH strips.
Time frame: baseline, three month post intervention and six month post intervention; before bedtime after brushing and rising time before brushing
the change of salivary flow rate
Oral Schirmer's test for five minutes before bedtime after brushing and rising time before brushing
Time frame: baseline, three month post intervention and six month post intervention
the change of health-related cognition
A total of 21 questionnaires Seven questionnaire were asked for children in eye, teeth and sleep dimension to examine the effectiveness of interventions
Time frame: baseline, three month post intervention and six month post intervention
Plan to share: No
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National Taiwan University