Bedtime Routines and Children's Health

Sponsor
National Taiwan University (Other)
Overall Status
Recruiting
CT.gov ID
NCT05201924
Collaborator
(none)
200
1
2
29.9
6.7

Study Details

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.

Condition or Disease Intervention/Treatment Phase
  • Behavioral: Bedtime routine
  • Behavioral: Control
N/A

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) Children Sleep Habit Questionnaire (CSHQ) results over 41 points or (2) average bedtime later than 10 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 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 12-hour sleep duration. Researchers will send interactive reminder messages periodically to maintain participants' compliance. A light meter will be used to monitor light exposure for 7 days to measure light circadian entrainment while doing outdoor activity, indoor reading, or screen device use and sleep. 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 measurement. Asthenopia pictures and eye blink times per minute are used to measure subjective and objective 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.

Study Design

Study Type:
Interventional
Anticipated Enrollment :
200 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Intervention Model Description:
An bedtime routine interventional group and a healthy lifestyle control groupAn bedtime routine interventional group and a healthy lifestyle control group
Masking:
Double (Participant, Care Provider)
Primary Purpose:
Prevention
Official Title:
Bedtime Routines and Health-related Outcomes in School-age Children
Actual Study Start Date :
Jan 31, 2021
Anticipated Primary Completion Date :
May 31, 2022
Anticipated Study Completion Date :
Jul 31, 2023

Arms and Interventions

Arm Intervention/Treatment
Experimental: Bedtime routine

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 12-hour sleep duration

Behavioral: Bedtime routine
a regular routine conducted around bedtime includes brush, book reading and regular bedtime

Active Comparator: control group

healthy lifestyle checklist

Behavioral: Control
a healthy control checklist

Outcome Measures

Primary Outcome Measures

  1. the change of bedtime activities and sleep patterns [7 days at baseline, three month post intervention and six month post intervention]

    self-administered sleep diary, including sleep patterns, screen device use 2 hours before bedtime, caffine food intake

  2. the change of bedtime routines [baseline, three month post intervention and six month post intervention]

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

  3. the change of children's sleep habits [three month post intervention and six month post intervention]

    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).

  4. The change of caregiver's sleep quality [baseline, three month post intervention and six month post intervention]

    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.

  5. The change of caregiver's daytime sleepiness [baseline, three month post intervention and six month post intervention]

    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.

  6. The change of pediatric daytime sleepiness [baseline, three month post intervention and six month post intervention]

    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

  1. the change of myopia [baseline, three month post intervention and six month post intervention]

    near vision eye chart

  2. the change of stereopsis [baseline, three month post intervention and six month post intervention]

    stereo book

  3. the change of objective Asthenopia [baseline, three month post intervention and six month post intervention]

    handy flicker for critical fusion frequency test. Normal CFF ranged between 30 to 50 Hz

  4. the change of subjective Asthnopia [baseline, three month post intervention and six month post intervention]

    self-administered pictures for eye symptoms. Higher score means more eye fatigue.

  5. the change of oral pH [baseline, three month post intervention and six month post intervention; before bedtime after brushing and rising time before brushing]

    pH values was tested using MACHEREY-NAGEL pH strips.

  6. the change of salivary flow rate [baseline, three month post intervention and six month post intervention]

    Oral Schirmer's test for five minutes before bedtime after brushing and rising time before brushing

  7. the change of health-related cognition [baseline, three month post intervention and six month post intervention]

    A total of 21 questionnaires Seven questionnaire were asked for children in eye, teeth and sleep dimension to examine the effectiveness of interventions

  8. light exposure [7 days at baseline]

    luxmeter was used to exaime the sunlight, indoor and bedtime exposure. Using as a covariate

Eligibility Criteria

Criteria

Ages Eligible for Study:
6 Years to 8 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Tsai, Han-Yi Taipei Taiwan 10051

Sponsors and Collaborators

  • National Taiwan University

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Han-Yi Tsai, National Taiwan University, National Taiwan University
ClinicalTrials.gov Identifier:
NCT05201924
Other Study ID Numbers:
  • 202007HM010
First Posted:
Jan 21, 2022
Last Update Posted:
Jan 21, 2022
Last Verified:
Jan 1, 2022
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Han-Yi Tsai, National Taiwan University, National Taiwan University
Additional relevant MeSH terms:

Study Results

No Results Posted as of Jan 21, 2022