MyopiaNCT05201924
Bedtime Routines and Children's Health
A study testing Bedtime routine in people with Myopia and Dental Caries, run by National Taiwan University at 1 site in Taiwan.
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. Read more about this study
- Who is it for?
- Ages 6 to 8 yearsHealthy volunteers can take part
- Conditions the study is for
- Myopia, Dental Caries, Sleep
- What is being tested?
- Bedtime routine
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 160 participants
- Where
- 1 siteTaiwan
- Study dates
- 31 Jan 2022to 31 Jan 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 6 to 8 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Children whose average bedtime later than 9:30 pm
- Children who sleep less than 9 hours or more than 11 hours
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Bedtime Routines and Health-related Outcomes in School-age Children
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.
Read the 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.
- Conditions
- Myopia, Dental Caries, Sleep, Asthenopia
- Being tested
- Bedtime routine, Control
- Keywords
- Myopia, dental caries, bedtime routine, sleep
- Medical subject headings
- Myopia, Dental Caries, Asthenopia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Bedtime routineBehavioural
a regular routine conducted around bedtime includes brush, book reading and regular bedtime
ControlBehavioural
a healthy control checklist
| Study group | Role | What they receive |
|---|---|---|
| Bedtime routine | Experimental | 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 Receives: Behavioral: Bedtime routine |
| control group | Active comparator | healthy lifestyle checklist Receives: Behavioral: Control |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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
Measured: 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).
Measured: 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.
Measured: 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.
Measured: 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.
Measured: baseline, three month post intervention and six month post intervention
Secondary outcomes (7)
the change of myopia
near vision eye chart
Measured: baseline, three month post intervention and six month post intervention
the change of stereopsis
stereo book
Measured: 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
Measured: 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.
Measured: baseline, three month post intervention and six month post intervention
the change of oral pH
pH values was tested using MACHEREY-NAGEL pH strips.
Measured: 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
Measured: 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
Measured: baseline, three month post intervention and six month post intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Jan 2022
- Study start31 Jan 2022
- Primary completion31 Jan 2023
- Study completion31 Jan 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for MyopiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- An bedtime routine interventional group and a healthy lifestyle control group
- Masking
- Double blind
- Who is masked
- Participant, Care provider
- Enrolment
- 160 participants (actual)
Sponsor and investigators
- Lead sponsor
- National Taiwan University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Han-Yi Tsai, National Taiwan University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05201924
- Sponsor's protocol ID
- 202007HM010
- Status last verified
- Nov 2024
- First submitted
- 21 Dec 2021
- Last updated
- 27 Nov 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Bedtime Routines and Health-related Outcomes in School-age Children
- ClinicalTrials.gov ID
- NCT05201924
- Acronym / sponsor ID
- 202007HM010
- Conditions
- Myopia, Dental Caries, Sleep, Asthenopia
- Keywords
- Myopia, dental caries, bedtime routine, sleep
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 160 participants (actual)
- Lead sponsor
- National Taiwan UniversityUniversity, hospital or other
- Study start
- 31 Jan 2022 (actual)
- Primary completion
- 31 Jan 2023 (actual)
- Study completion
- 31 Jan 2023 (actual)
- First posted
- 21 Jan 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, care provider)
- Number of arms
- 2
- Model description
- An bedtime routine interventional group and a healthy lifestyle control group
| Arm | Type | Receives |
|---|---|---|
| Bedtime routine | Experimental | Behavioral: Bedtime routineA 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 |
| control group | Active comparator | Behavioral: Controlhealthy lifestyle checklist |
Who may qualify
- Ages
- 6 to 8 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (2 listed)
- Children whose average bedtime later than 9:30 pm
- Children who sleep less than 9 hours or more than 11 hours
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Bedtime routinea regular routine conducted around bedtime includes brush, book reading and regular bedtime | Behavioural | Bedtime routine |
| Controla healthy control checklist | Behavioural | control group |
Primary outcome
the change of bedtime activities and sleep patterns
Time frame: 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
the change of bedtime routines
Time frame: 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
the change of children's sleep habits
Time frame: 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).
The change of caregiver's sleep quality
Time frame: 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.
The change of caregiver's daytime sleepiness
Time frame: 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.
The change of pediatric daytime sleepiness
Time frame: 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.
7 secondary outcomes
the change of myopia
Time frame: baseline, three month post intervention and six month post intervention
the change of stereopsis
Time frame: baseline, three month post intervention and six month post intervention
the change of objective Asthenopia
Time frame: baseline, three month post intervention and six month post intervention
the change of subjective Asthnopia
Time frame: baseline, three month post intervention and six month post intervention
the change of oral pH
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
Time frame: baseline, three month post intervention and six month post intervention
the change of health-related cognition
Time frame: baseline, three month post intervention and six month post intervention
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Nov 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Bedtime routine in people with Myopia and Dental Caries, run by National Taiwan University at 1 site in Taiwan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 27 Nov 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
the change of bedtime activities and sleep patterns (time frame: 7 days at baseline, three month post intervention and six month post intervention). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Nov 2024.