Insomnia/anxiety and depression comorbidity
Conditions
Interventions
Experimental group:Lighting that simulates dynamic changes in sunlight
control group:regular light
Sponsors
Tangdu Hospital
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: 1) Aged over 18 years old; 2) Meet the diagnostic criteria of ICSD-3 chronic insomnia disorder: A-F must be met: A. The patient complains, one or more of the following symptoms: ? Difficulty falling asleep; ? Difficulty maintaining sleep; ? Early awakening; B. The patient complains of one of the following or more symptoms related to difficulty sleeping at night: ? fatigue/discomfort; ? impaired concentration, concentration, or memory; ?) impaired social, family, occupational functioning, or decreased academic performance; ? emotional instability/easy Irritability; ? daytime sleepiness; ? behavioral problems (such as hyperactivity, impulsiveness, aggressive behavior); ? lack of motivation, energy, or motivation. ? Increased tendency to make mistakes/accidents; ? Anxiety or dissatisfaction with sleep; C. Sleep/wake difficulties cannot be explained solely by insufficient sleep opportunities (eg, adequate sleep time allocated) or poor sleep environment (eg, environmental safety) , dark, quiet, comfortable); D. Sleep disturbance and related daytime symptoms occur at least 3 times a week; E. Sleep disturbance and related daytime symptoms persist for at least 3 months; F. Sleep/wake difficulty cannot be treated with another Sleep disorders better explained. 3) Hamilton Depression Scale (HAMD) score = 8; 4) Hamilton Anxiety Scale (HAMA) score = 7; 5) Pittsburgh Sleep Quality Index (PSQI) score = 5 or Insomnia Severity Index (ISI) score = 10 6) Sign informed consent.
Exclusion criteria
Exclusion criteria: (1) Clinically significant diseases: including acute phase of chronic obstructive pulmonary disease, acute and/or severe respiratory depression, severe liver damage, moderate and/or severe renal damage, active phase of myasthenia gravis, dementia, severe pain, drug dependence or alcohol dependence; or a history of malignancy within the past 5 years (except for adequately treated basal cell carcinoma), or the investigator believes that may affect the safety of the subject or interfere with the study assessing the disease; uncontrolled thyroid disease; research During planned surgery. (2) Chronic eye diseases: glaucoma, diabetic retinopathy EURODIAB grade 3, 4 or 5 (severe proliferative or non-proliferative retinopathy, photocoagulative retinopathy, proliferative retinopathy, age-related macular degeneration and possible impairment of the efficacy of phototherapy or other medical conditions for safety), blindness, cataracts, retinal detachment. (3) Facial dermatitis and sunburn erythema, solar dermatitis, polymorphic sun rash, chronic actinic dermatitis or cheilitis, dermatomyositis, lupus erythematosus, etc. (4) Young's Mania Rating Scale (YMRS) = 6 points; any manic, hypomanic, or mixed episodes in the past 6 months. (5) Severe suicidal ideation, planned or unplanned suicidal ideation at the time of screening or within 6 months of screening. Any suicidal act within the past 10 years (6) Patients with severe mental illness such as schizophrenia; (7) Report a history of sleep-related violent behavior, or sleep-driving, or any other complex sleep-related behavior (such as making phone calls or preparing and eating during sleep) (8) Meet the diagnosis of restless legs syndrome and score =16 on the International Restless Legs Scale; (9) Shift work in the past six months; work across time zones (more than 2 time zones) in the past 2 months or plan to travel through more than 3 time zones during the study period (mainland China will be regarded as 1 time zone); (10) Sleep breathing diseases including obstructive sleep apnea (with or without continuous positive airway pressure therapy) have been diagnosed or considered, and Stop Bang score = 5); (11) Those who adjusted related drugs to improve sleep and regulate anxiety and depression in the 2 weeks before enrollment, and who wished to be treated by adjusting drugs during the study period; (12) Habitual naps during the day more than 3 times a week; (13) Those who habitually consume caffeinated beverages after 18:00 and are unwilling to stop using caffeine after 18:00 during their participation in the study; (14) Reported weekly habitual intake of alcoholic beverages, or unwillingness to limit alcohol intake during study participation (no more than 2 drinks per day, or no alcohol intake within 3 hours before bedtime); (15) Currently being treated with photosensitive drugs: such as phenothiazine, antimalarial drugs, propranolol, melatonin, hypericum preparations, estrogen preparations, progestin preparations, stimulants, non-steroidal anti-inflammatory drugs (sodium salicylate, ibuprofen, diclofenac, etc.), retinoids (isotretinoin, acitretin, retinoid, tretinoin ointment), glucocorticoids, cytostatics, sulfonamides, azoles Antifungal drugs (griseofulvin, ketoconazole, itraconazole), quinolones, antihistamines (chlorpheniramine, diphenhydramine, etc.), aminoglycosides (chloramphenicol, genta Mycin, etc.), sulfonylurea hypoglycemic drugs (glibenclamide tablets, glipizide, etc.), anti-
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Pittsburgh Sleep Quality Scale Score; | — |
Secondary
| Measure | Time frame |
|---|---|
| Insomnia Severity Scale Score;Hamilton Depression Inventory Score;Hamilton Anxiety Scale Score;actigraphy parameters;sleep diary parameters;PSG parameters;Adverse reaction scale; | — |
Countries
China
Contacts
Public Contactsu changjun
Tangdu Hospital
Outcome results
None listed