Clinical Trials Logo

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.


Clinical Trial 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


Related Conditions & MeSH terms


NCT number NCT05201924
Study type Interventional
Source National Taiwan University
Contact Han-Yi Tsai
Phone 886-952284300
Email [email protected]
Status Recruiting
Phase N/A
Start date January 31, 2021
Completion date July 31, 2023

See also
  Status Clinical Trial Phase
Recruiting NCT04923841 - Myopia Control Using Bright Light Therapy and Myopic Defocus N/A
Active, not recruiting NCT04080128 - Examination of Myopia Progression and Soft Bifocal Contact Lens Myopia Control N/A
Completed NCT04604405 - Effects of 650nm Low Energy Light on Human Retina and Choroid Microcirculation N/A
Completed NCT04492397 - Comparing The Performance Of Two Different Daily Disposable Lenses (MIKI) N/A
Completed NCT04536571 - Vision Stability and Preference for Soft Toric vs. Soft Spherical Contact Lenses N/A
Completed NCT03934788 - the Clinical Performance of the Oxysoft Daily Disposable Silicone Hydrogel Soft Contact Lens N/A
Completed NCT03701516 - Clinical Evaluation of Etafilcon A Contact Lenses Using a Novel Molding Process 2 N/A
Completed NCT03139201 - Clinical Performance of the OxyAqua Daily Disposable Silicone Hydrogel Soft Contact Lens N/A
Completed NCT02555722 - Evaluation of the CooperVision, Inc. Fanfilcon A and Enfilcon A Daily Wear Contact Lenses When Used for Frequent Replacement for up to One (1) Month of Daily Wear N/A
Active, not recruiting NCT03006601 - Effect of Vision Therapy in Myopic Children With Poor Accommodative Response N/A
Completed NCT02920983 - A Clinical Comparison of Three Soft Daily Disposable Contact Lenses N/A
Completed NCT02920957 - Performance Comparison Between Comfilcon A and Senofilcon C Lenses N/A
Recruiting NCT02578407 - Pilot Study of Accommodative/Vergence Therapy to Modify Accommodative Function in Children With Myopia N/A
Completed NCT02550353 - Changes Between Lenticule Extraction and Femtosecond Laser-assisted Laser in Situ Keratomileusis N/A
Completed NCT02537730 - BIOCLEAN MPS (Multi-Purpose Solution) VII in Combination With Biofinity Lens: A Two Week Crossover Study N/A
Completed NCT02551796 - Early Changes Among FLEx, LASIK and FS-LASIK N/A
Completed NCT02423109 - Bilateral Dispensing Study of Fanfilcon A Toric Versus Enfilcon A Toric Lenses N/A
Completed NCT02553395 - One Week Assessment of The Phenacite Lens N/A
Completed NCT02248727 - Clinical Performance of Existing Wearers of Avaira Sphere Following a Refit With Clariti Elite Sphere N/A
Completed NCT02231606 - Potentiating Rural Investment in Children's Eyecare (PRICE) N/A