Normal volunteers
Conditions
Interventions
Cross-over from blue light-blocking eyeglasses to sham eyeglasses
Cross-over from sham eyeglasses to blue light-blocking eyeglasses
Sponsors
Sleep and Circadian Neurobiology Laboratory, Stanford University School of Medicine
Ota Memorial Sleep Center, ota general hospital Memorial Research Institute Clinic
Eligibility
Sex/Gender
Male
Inclusion criteria
Inclusion criteria: (1) Healthy male elementary school student aged 10 to 12 years at consent (2) Regularly wears eyeglasses for correction of visual acuity in daily life (3) Regularly exposed to an average of at least 1 hour of blue light per day from LED displays, etc., before going to bed (4) Written informed consent obtained from the volunteer and his legal guardian prior to study participation
Exclusion criteria
Exclusion criteria: (1) Regularly wears in daily life the following lenses that cannot be prepared to the specifications of the lenses used in the study Lenses with refractive powers outside the following range (myopia prescriptions: SPH: -8.00 to 0 D, CYL: -4.00 to 0 D, hyperopia prescriptions: SPH: 0 to +4.00 D, CYL: 0 to +4.00 D) or non-monofocal lenses such as progressive lenses and prismatic lenses (2) The refractive power of the eyeglasses requires remeasurement in the hospital or ophthalmology department because it is realized that the refractive power of the eyeglasses regularly used in daily life is not suitable. (3) The refractive power of the eyeglasses regularly used in daily life cannot be tested at an eyeglass store. (4) Takes oral medications, supplements, etc., that affect sleep, the autonomic nervous system, or the central nervous system. (5) Has previous or complicating sleep disorders, mental illness, immunologic/allergic diseases, metabolic disorders, corneal disorders, retinal disorders, dry eye, asthenopia, or the like (6) Requires pharmacotherapy for pollinosis, etc. (7) Has infection designated by the Infectious Disease Law or bloodborne infection (e.g., HBV, HCV, HIV, or syphilis) (including close contact with such diseases) (8) Cannot wear correctly the testing instrument before going to bed under the guidance of a legal guardian (9) Has irregular sleep habits (10) Planned changes in living environment during study participation (11) Deemed otherwise unsuitable for the study by the investigator
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Evaluation of salivary melatonin concentration | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Evaluation of circadian rhythm 2. Evaluation of sleepiness, mood, and motivation (modified NRS sleep scale) 3. Evaluation of quality and quantity of sleep (elementary school student version of the children's sleep questionnaire/chronotype evaluation) | — |
Countries
Japan
Contacts
Public ContactShintaro Chiba
Ota general hospital Memorial Research Institute Clinic Ota Memorial Sleep Center
Outcome results
None listed