Insomnia
Conditions
Interventions
Sponsors
Eligibility
Inclusion criteria
Inclusion criteria: 1. Insomnia Patient Group: (1) Meet the diagnostic criteria for Insomnia Disorder according to the Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-5): 1) The patient reports dissatisfaction with sleep quality or sleep duration, manifesting as: difficulty initiating sleep, early morning awakening, or difficulty maintaining sleep (frequent nocturnal awakenings or inability to return to sleep after awakening); 2) The insomnia causes significant clinical distress or impairment in social, occupational, educational, or other important areas of functioning; 3) The above symptoms occur at a frequency of >3 times per week; 4) The above symptoms persist for a duration of >=3 months; 5) The patient has adequate opportunity and a favorable environment for sleep; 6) The patient reports at least one daytime consequence related to poor sleep (e.g., fatigue, impaired cognitive or emotional functioning); 7) The above symptoms cannot be better explained by another sleep-wake disorder (e.g., narcolepsy, sleep-disordered breathing, circadian rhythm sleep-wake disorder, parasomnias); 8) The above symptoms are not attributable to the physiological effects of drugs, substance abuse, or other substances; 9) The insomnia symptoms are not secondary to another medical or psychiatric condition. (2) No restriction on gender; age 18–80 years; (3) No significant psychosocial stressors; no severe life or psychological events affecting sleep within the recent period (except sleep-related fear). 2. Healthy Control Group: (1) Matched with the insomnia patient group in terms of demographic characteristics such as gender, age, and education level; (2) Hamilton Anxiety Scale (HAMA) score <7, Hamilton Depression Scale (HAMD) score <7, Insomnia Severity Index (ISI) score <8; (3) No intake of alcohol, caffeine, or other psychoactive substances within 24 hours prior to assessment; (4) Voluntarily participate in this study and provide written informed consent.
Exclusion criteria
Exclusion criteria: 1. Exclusion Criteria for the Insomnia Patient Group: (1) Presence of a diagnosed physical illness known to cause insomnia; (2) Presence of other psychiatric disorders (e.g., severe anxiety, major depression, mania, bipolar disorder, or schizophrenia) that impair treatment compliance; (3) History of receiving cognitive behavioral therapy or related psychological interventions for insomnia; (4) History of substance abuse involving alcohol, drugs, excessive caffeine, or other psychoactive substances; (5) Pregnancy or lactation; (6) Illiteracy or inability to comprehend study materials; (7) Shift workers. 2. Exclusion Criteria for the Healthy Control Group: (1) Personal history of psychiatric disorder or family history of psychiatric illness; (2) Presence of serious physical illnesses (e.g., coronary heart disease, thyroid disease, malignancy); (3) Brain injury due to any cause (e.g., traumatic brain injury, stroke, Parkinson’s disease, dementia, or epilepsy); (4) History of substance abuse involving alcohol, drugs, excessive caffeine, or other psychoactive substances.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Insomnia severity; | — |
Secondary
| Measure | Time frame |
|---|---|
| Sleep conditions;Depression;Anxiety;Hyperarousal traits;Beliefs and attitudes about sleep;Heart Rate;Sleep quality ;Daytime sleepiness;Heart Rate Variability;Skin Conductance Level;Internal perception; | — |
Countries
China
Contacts
The First Hospital of Dalian Medical University