Bedtime Routines and Children's Health

Sleep Clinical Trial

Official title:

Bedtime Routines and Health-related Outcomes in School-age Children

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05201924
• Other study ID #: 202007HM010
• Status: Completed
• Phase: N/A
• Start date: January 31, 2021
• Est. completion date: January 31, 2023

Study information

• Verified date: March 2023
• Source: National Taiwan University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 160
• Est. completion date: January 31, 2023
• Est. primary completion date: January 31, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 6 Years to 8 Years

Eligibility

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

Related Conditions & MeSH terms

• Asthenopia
• Dental Caries
• Myopia
• Sleep

Intervention

Behavioral:
• Bedtime routine
a regular routine conducted around bedtime includes brush, book reading and regular bedtime
• Control
a healthy control checklist

Locations

Country	Name	City	State
Taiwan	Tsai, Han-Yi	Taipei

Sponsors (1)

Lead Sponsor	Collaborator
National Taiwan University

Country where clinical trial is conducted

Taiwan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	7 days at baseline, three month post intervention and six month post intervention
Primary	the change of bedtime routines	Bedtime routine questionnaire (Handerson & Jordan, 2010): the subscale of bedtime consistency and bedtime adaptive activities	baseline, three month post intervention and six month post intervention
Primary	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).	three month post intervention and six month post intervention
Primary	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.	baseline, three month post intervention and six month post intervention
Primary	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.	baseline, three month post intervention and six month post intervention
Primary	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.	baseline, three month post intervention and six month post intervention
Secondary	the change of myopia	near vision eye chart	baseline, three month post intervention and six month post intervention
Secondary	the change of stereopsis	stereo book	baseline, three month post intervention and six month post intervention
Secondary	the change of objective Asthenopia	handy flicker for critical fusion frequency test. Normal CFF ranged between 30 to 50 Hz	baseline, three month post intervention and six month post intervention
Secondary	the change of subjective Asthnopia	self-administered pictures for eye symptoms. Higher score means more eye fatigue.	baseline, three month post intervention and six month post intervention
Secondary	the change of oral pH	pH values was tested using MACHEREY-NAGEL pH strips.	baseline, three month post intervention and six month post intervention; before bedtime after brushing and rising time before brushing
Secondary	the change of salivary flow rate	Oral Schirmer's test for five minutes before bedtime after brushing and rising time before brushing	baseline, three month post intervention and six month post intervention
Secondary	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	baseline, three month post intervention and six month post intervention