Chronic insomnia disorder
Conditions
Interventions
Treatment group:Slow wave combined charged particle intervention
Sham treatment group:Fake treatment with similar-looking devices
Sponsors
Hainan Hospital Ethics Committee, Ruijin Hospital Affiliated to Shanghai Jiao Tong University School of Medicine
Eligibility
Sex/Gender
All
Age
18 Years to 80 Years
Inclusion criteria
Inclusion criteria: 1. Age =18 years old 2. Patients diagnosed with chronic insomnia disorder according to the American Academy of Sleep Medicine (AASM) International Classification of Sleep Disorders (3rd Edition)
Exclusion criteria
Exclusion criteria: 1. Any history of substance abuse, serious neurological or mental illness 2. History of neurosurgery and head trauma 3. People implanted with various types of electronic medical treatment or auxiliary devices 4. Wear all kinds of medical electronic equipment and instruments (such as dynamic electrocardiogram, electronic kidney, electronic cochlea, etc.) 5. Not right-handed 6. Mri scan contraindications or reluctance to complete MRI scan
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Pittsburgh Sleep Quality Index (PSQI); | — |
Secondary
| Measure | Time frame |
|---|---|
| Athens Insomnia Scale (AIS);Hamilton Depression/Anxiety Scale (HAMD/HAMA);Emergency indicators (salivary cortisol; Serum cortisol, BDNF, proBDNF, tPA, NPS, GDNF);Polysomnia monitoring;Montreal cognitive scale (MoCA); | — |
Countries
China
Contacts
Public ContactChen Lixiong
Hainan Hospital, Ruijin Hospital Affiliated to Shanghai Jiao Tong University School of Medicine
Outcome results
None listed