Sleep disorder
Conditions
Interventions
Juvenile healthy volunteer:40Hz flash light for 30 minutes once before going to bed
Juvenile insomnia disorder Control group:Normal light for 30 minutes once before going to bed
Juvenile insomnia disorder Experimental group:40Hz flash light for 30 minutes once before going to bed
Adults healthy volunteer:40Hz flash light for 30 minutes once before going to bed
Adults insomnia disorder Control group:Normal light for 30 minutes once before going to bed
Adults insomnia disorder Experimental group:40Hz flash light for 30 minutes once before going to bed, continue treatment for 14 consecutive days
Sponsors
Eye Hospital, Wenzhou Medical University
Eligibility
Sex/Gender
All
Age
6 Years to 70 Years
Inclusion criteria
Inclusion criteria: 1. Healthy subjects: A) Healthy subjects meet the Health Status Scale and less than 6 points; B) Children aged 6-18 years: a total of 15 people are included. Adult age 18-70 years: A total of 30 people were included. C) No difficulty in understanding and good compliance; D) Voluntarily cooperate and sign an informed consent form. 2. Patients with insomnia disorders: A) Meet the diagnostic criteria for insomnia disorder (Diagnostic and Statistical Manual of Mental Disorders, fifth edition, DSM-5) and meet the following criteria: B) Disease duration =1 month; C) Sleep duration of at least three nights a week within 1 month before screening. 30 minutes or subjective total sleep time =6 hours. D) The daily bedtime within one month before screening is between 9 PM and 1 am the next day, and the daily time in bed is at least 7 hours per night; E) During the screening period, polysomnography (PSG) monitoring was performed for two consecutive nights, and the mean total sleep time (TST) was =240 minutes and =390 minutes. F) No difficulty in understanding and good compliance; E) Voluntarily cooperate and sign the informed consent.
Exclusion criteria
Exclusion criteria: 1. Healthy subjects: A) abusers of alcohol, coffee or drugs in the past 6 months; B) Unable to complete the questionnaire due to obvious hearing or vision impairment; C) Failing to sign the informed consent form. 2. Patients with insomnia disorders: A) Phototherapy intervention will induce or aggravate the primary disease: photosensitive dermatitis, history of epilepsy; B) Mental illness: such as anxiety disorder, depression, schizophrenia and insomnia caused by post-traumatic stress disorder; C) abusers of alcohol, coffee or drugs in the past 6 months; D) Drugs that may impair alertness, mental function, and behavior, such as anticholinergic drugs and memory-enhancing drugs, were used or expected to be used within 7 days before enrollment or less than 5 half-lives. The excluded dose had been stable for at least 1 month before enrollment and did not change the dosing regimen during the study; E) Used drugs or health products that regulate sleep function or affect sleep within 14 days before enrollment or within less than 5 half-lives of drugs; F) Long-term use of thyroid or glucocorticoid replacement drugs (e.g., thyroxine tablets, methimazole, goserelin, etc.) was required, except that the dosage had been stable for at least 6 months before enrollment, and the dosing regimen did not change during the study; G) Working or living across 3 or more time zones within 14 days before enrollment; H) Participated in other clinical studies before enrollment, and the last medication/treatment time was less than 30 days from the enrollment time; I) Sleep was affected due to weight loss plan or change of exercise habits within 30 days before enrollment; J) Unable to complete the questionnaire due to obvious hearing or vision impairment; K) The subject is pregnant; L) Fail to sign the informed consent form.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| TST, Total sleep time;security indexes; WASO, Wake-time After Sleep Onset;AF, Arousal frequency;EM SOL, REM Sleep onset latency; | — |
Secondary
| Measure | Time frame |
|---|---|
| SOL, Sleep onset latency;SE, Sleep efficiency; | — |
Countries
China
Contacts
Public ContactJiang-Fan Chen
Eye Hospital, Wenzhou Medical University
Outcome results
None listed