Myopia Clinical Trial
Official title:
Bedtime Routines and Health-related Outcomes in School-age Children
Verified date | March 2023 |
Source | National Taiwan University |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
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 |
Country | Name | City | State |
---|---|---|---|
Taiwan | Tsai, Han-Yi | Taipei |
Lead Sponsor | Collaborator |
---|---|
National Taiwan University |
Taiwan,
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 |
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