insomnia disorder
Conditions
Interventions
Sponsors
Eligibility
Inclusion criteria
Inclusion criteria: 1.Inclusion Criteria for Patients with Insomnia Disorder: Male and female individuals aged 18-65 years, of Han ethnicity, and right-handed. Mini-Mental State Examination (MMSE) score >=27. Persistent (>1 month) difficulty initiating sleep or maintaining sleep despite adequate opportunity for sleep. During a two-week sleep diary monitoring period, at least three nights per week with a sleep latency or wakefulness after sleep onset of >=30 minutes. Total score on the Insomnia Severity Index (ISI) >10, with scores on the interference or distress items>=2. Inclusion Criteria for Healthy Sleepers: Individuals aged 18-65 years, with no restrictions on gender. Of Han ethnicity, and right-handed. MMSE score >=27. No complaints of sleep disorders. Self-reported sleep latency =5 nights per week in the past 6 months and during a two-week sleep diary monitoring period. ISI total score <=7, with scores on the interference or distress items <2. Routine bedtime between 9 PM and 1 AM in the past three months.
Exclusion criteria
Exclusion criteria: 1.Exclusion Criteria for Patients with Insomnia Disorder: - A diagnosis of schizophrenia or bipolar disorder. - Untreated psychiatric disorders such as major depressive disorder or generalized anxiety disorder. - High risk of suicide. - History of alcohol or substance abuse within the past year. - Progressive diseases (e.g., cancer) or neurodegenerative diseases (e.g., dementia). - Use of medications known to cause insomnia, such as steroids. - Other sleep disorders: moderate sleep apnea syndrome (Apnea/Hypopnea Index >15), restless legs syndrome, periodic limb movements during sleep (more than 15 periodic limb movements per hour associated with arousal), or circadian rhythm sleep disorders (e.g., advanced sleep phase syndrome). - Contraindications for functional magnetic resonance imaging (fMRI) examination, including any implants or metal foreign bodies in the body, claustrophobia, etc. - Pregnancy or lactation. (2) Exclusion Criteria for Healthy Sleepers: - A diagnosis of schizophrenia or bipolar disorder. - Untreated psychiatric disorders such as major depressive disorder or generalized anxiety disorder. - High risk of suicide. - History of alcohol or substance abuse within the past year. - Progressive diseases (e.g., cancer) or neurodegenerative diseases (e.g., dementia). - Sleep disorders: insomnia disorder, moderate sleep apnea (Apnea/Hypopnea Index >15), periodic limb movements during sleep (more than 15 periodic limb movements per hour associated with arousal), etc. - Contraindications for fMRI examination, including any implants or metal foreign bodies in the body, claustrophobia, etc. - Pregnancy or lactation. Note: All participants must discontinue the use of sleep-promoting medications and alcohol after 7 PM at least two weeks before baseline assessment. Patients taking SSRIs or SNRIs with stable doses for more than three months and experiencing partial relief of mood or anxiety symptoms may be included in the study, while those using TCAs, MAOIs, or atypical antidepressants are excluded to avoid the interference of these medications on sleep affecting the study results.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Overall Attention Bias Score.; | — |
Countries
China
Contacts
Peking University Sixth Hospital ( Institute of Mental Health )