Effects of Photobiomodulation on Insomnia in the Elderly: Clinical Trials of Phototherapy Devices
The study will recruit 60 participants aged 60 and above, who suffered from insomnia for at least 3 months. Sleep parameters and chronotypes assessed with questionnaires and actigraphy, daytime sleepiness, and biological rhythm (dim light melatonin onset) will be measured. The intervention involves light exposure using a prototype device developed by GCSOL Tech Co., Ltd., a company with expertise in light therapy research and development. Three conditions will be tested (1) bright light; (2) near-infrared light; (3) bright light+ near-infrared light. Data analysis will employ paired t-tests to compare sleep parameters and dim light melatonin onset before and after treatment. Kruskal-Wallis tests and multivariate linear regression will be used to examine differences between intervention groups, controlling for gender and age. Safety analysis will include monitoring adverse events.
- EligibilityCriteria: Inclusion Criteria:  Pittsburgh Sleep Quality Index score is 8 or above. Early wakening ( 30 minutes before expected), or interruptted sleep for more than 30 minutes, lasting for more than 3 months.  Exclusion Criteria:  Movement disorder, inability to move independently. Skin diseases, skin cancer, photosensitive skin diseases, or taking drugs that may cause photosensitivity (lithium salts, melatonin, antibiotics, A acid). Eye diseases such as glaucoma, diabetic retinopathy, and cataracts. Bipolar disorder. Light-induced epilepsy. Sleep disorders such as sleep apnea and involuntary leg twitching. Currently taking sedative-hypnotic drugs or receiving other non-drug treatments. Beck depression inventory-II score is greater than 13 points. Those who use cardiac rhythm regulators or artificial cardiopulmonary pacemakers. Acute illness. Abnormal blood pressure or fever. Pregnancy and pregnant women. Special physical abnormalities and sensory nerve abnormalities. Infectious diseases. Coagulation disorder. - HealthyVolunteers: No - Gender: All - MinimumAge: 60 Years - StdAgeList: Adult, Older Adult