Insomnia disorder
Conditions
Interventions
Sponsors
Huashan Hospital, Fudan University
Eligibility
Sex/Gender
All
Age
18 Years to 65 Years
Inclusion criteria
Inclusion criteria: 1.Meet the diagnostic criteria for chronic insomnia established in this study (age 18–65 years, regardless of gender); 2.Regular lifestyle without transmeridian travel or night shift work in the 2 weeks prior to enrollment; 3.Stable regimen of regular therapeutic medications for at least 1 month prior to enrollment; 4.Voluntarily participate in the clinical trial and provide signed informed consent.
Exclusion criteria
Exclusion criteria: 1. PSG suggests apnea-hypopnea index of >=15/hr and untreated, or periodic limb movement index related microarousal index >=10/hr; 2. Those who changed the type and dose of the original sleeping drug during the study; 3. Those who have not been treated or currently have serious mental illness, or who are at risk of negative suicide; 4. Previous or current history of drug or alcohol abuse (including alcohol consumption >=14 drinks per week); 5. Those who have hearing impairment and cannot perceive powder noise stimuli; 6. Presence of acute or unstable disease conditions (such as heart failure, hypertension, etc.).
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| SO amplitude and duration; | — |
Secondary
| Measure | Time frame |
|---|---|
| Assessment of daytime functioning;Adverse events;Mood Assessment;Objective sleep parameters;Subjective sleep quality; | — |
Countries
China
Contacts
Public ContactHuan Yu
Huashan Hospital, Fudan University
Outcome results
None listed