Chronic insomnia disorder
Conditions
Interventions
Patients with chronic insomnia disorder:Low signal-to-noise ratio white noise intervention
Sponsors
Hefei Fourth People’s Hospital
Eligibility
Sex/Gender
All
Age
18 Years to 60 Years
Inclusion criteria
Inclusion criteria: 1. Meets the diagnostic criteria for chronic insomnia disorder according to the International Classification of Sleep Disorders, 3rd Edition (ICSD-3); 2. Aged 18 to 60 years, no gender restrictions; 3. Insomnia Severity Index (ISI) >= 15 points; 4. Regular bedtime between 8:30 PM and midnight, with a consistent sleep duration of 6.5 to 9 hours; 5. Voluntary participation and signed informed consent.
Exclusion criteria
Exclusion criteria: 1. Individuals with neurological disorders (e.g., epilepsy, stroke) or psychiatric disorders (including depression, anxiety disorders, schizophrenia, etc.), with a Hamilton Depression Rating Scale-24 (HAMD-24) score >=14 or a Hamilton Anxiety Rating Scale (HAMA) score >=13; 2.Presence of severe sleep apnea (apnea-hypopnea index >=30 events/hour), restless legs syndrome, narcolepsy, or other sleep disorders; 3. History of alcohol or substance abuse within the past 6 months; 4.Use of any sleep-affecting medications, health supplements, or receipt of other insomnia treatments within 2 weeks prior to enrollment; 5.Pregnant or lactating women, or those planning pregnancy during the study period and unwilling to use effective contraception; 6.Presence of MRI contraindications (e.g., metallic implants, severe claustrophobia) or inability to undergo fNIRS/ERP testing for other reasons; 7. Other circumstances deemed unsuitable for trial participation by the investigator.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Objective sleep measures; | — |
Secondary
| Measure | Time frame |
|---|---|
| Resting state brain functional data;Functional near - infrared spectroscopy data;Event-related potential data;Depression and anxiety symptoms;Insomnia Severity;Sleep quality;Subjective sleep quality; | — |
Countries
China
Contacts
Public ContactDaomin Zhu
Hefei Fourth People’s Hospital
Outcome results
None listed