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Bedtime Routines and Children's Health

Primary Purpose

Myopia, Dental Caries, Sleep

Status
Completed
Phase
Not Applicable
Locations
Taiwan
Study Type
Interventional
Intervention
Bedtime routine
Control
Sponsored by
National Taiwan University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Myopia focused on measuring Myopia, dental caries, bedtime routine, sleep

Eligibility Criteria

6 Years - 8 Years (Child)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  1. Children whose average bedtime later than 10 p.m
  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

Sites / Locations

  • Tsai, Han-Yi

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Bedtime routine

control group

Arm Description

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

healthy lifestyle checklist

Outcomes

Primary Outcome Measures

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
the change of bedtime routines
Bedtime routine questionnaire (Handerson & Jordan, 2010): the subscale of bedtime consistency and bedtime adaptive activities
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).
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.
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.
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.

Secondary Outcome Measures

the change of myopia
near vision eye chart
the change of stereopsis
stereo book
the change of objective Asthenopia
handy flicker for critical fusion frequency test. Normal CFF ranged between 30 to 50 Hz
the change of subjective Asthnopia
self-administered pictures for eye symptoms. Higher score means more eye fatigue.
the change of oral pH
pH values was tested using MACHEREY-NAGEL pH strips.
the change of salivary flow rate
Oral Schirmer's test for five minutes before bedtime after brushing and rising time before brushing
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

Full Information

First Posted
December 21, 2021
Last Updated
March 27, 2023
Sponsor
National Taiwan University
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1. Study Identification

Unique Protocol Identification Number
NCT05201924
Brief Title
Bedtime Routines and Children's Health
Official Title
Bedtime Routines and Health-related Outcomes in School-age Children
Study Type
Interventional

2. Study Status

Record Verification Date
March 2023
Overall Recruitment Status
Completed
Study Start Date
January 31, 2021 (Actual)
Primary Completion Date
January 31, 2023 (Actual)
Study Completion Date
January 31, 2023 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
National Taiwan University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Myopia, Dental Caries, Sleep, Asthenopia
Keywords
Myopia, dental caries, bedtime routine, sleep

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
An bedtime routine interventional group and a healthy lifestyle control group
Masking
ParticipantCare Provider
Allocation
Randomized
Enrollment
160 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Bedtime routine
Arm Type
Experimental
Arm Description
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
Arm Title
control group
Arm Type
Active Comparator
Arm Description
healthy lifestyle checklist
Intervention Type
Behavioral
Intervention Name(s)
Bedtime routine
Intervention Description
a regular routine conducted around bedtime includes brush, book reading and regular bedtime
Intervention Type
Behavioral
Intervention Name(s)
Control
Intervention Description
a healthy control checklist
Primary Outcome Measure Information:
Title
the change of bedtime activities and sleep patterns
Description
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
Title
the change of bedtime routines
Description
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
Title
the change of children's sleep habits
Description
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
Title
The change of caregiver's sleep quality
Description
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
Title
The change of caregiver's daytime sleepiness
Description
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
Title
The change of pediatric daytime sleepiness
Description
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
Secondary Outcome Measure Information:
Title
the change of myopia
Description
near vision eye chart
Time Frame
baseline, three month post intervention and six month post intervention
Title
the change of stereopsis
Description
stereo book
Time Frame
baseline, three month post intervention and six month post intervention
Title
the change of objective Asthenopia
Description
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
Title
the change of subjective Asthnopia
Description
self-administered pictures for eye symptoms. Higher score means more eye fatigue.
Time Frame
baseline, three month post intervention and six month post intervention
Title
the change of oral pH
Description
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
Title
the change of salivary flow rate
Description
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
Title
the change of health-related cognition
Description
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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
6 Years
Maximum Age & Unit of Time
8 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Children whose average bedtime later than 9:30 pm Children who sleep less than 9 hours or more than 11 hours Exclusion Criteria: intellectual disability prior to pre-school age diagnosed by physicians special education students less than 15 school day per month medications used that influence sleep congenital eye diseases dental emergencies
Facility Information:
Facility Name
Tsai, Han-Yi
City
Taipei
ZIP/Postal Code
10051
Country
Taiwan

12. IPD Sharing Statement

Plan to Share IPD
No

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Bedtime Routines and Children's Health

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