Insomnia
Conditions
Interventions
Sponsors
Eligibility
Inclusion criteria
Inclusion criteria: 1.Age 18–65 years, regardless of gender; 2.Meet the diagnostic criteria for insomnia disorder as defined by the American Psychiatric Association’s Diagnostic and Statistical Manual of Mental Disorders (DSM), including difficulty falling asleep (>=30 minutes), light sleep, poor sleep quality, frequent awakenings (more than 2 times per night), early morning awakening, difficulty returning to sleep after waking, daytime fatigue and weakness, total daily sleep time =30 days; 3.Pittsburgh Sleep Quality Index (PSQI) score >7.
Exclusion criteria
Exclusion criteria: 1.Allergy to lidocaine; 2.Severe hepatic or renal impairment, hematological disorders (coagulation dysfunction: prothrombin time or activated partial thromboplastin time above the upper normal limit, international normalized ratio >=1.4, or platelet count 20 and a Hamilton Anxiety Rating Scale (HAMA) score >14; 4.Skin lesions or infections on the neck, temples, or face; 5.Pregnant, breastfeeding, or planning pregnancy; 6.Known alcoholism or dependence on other psychoactive substances; 7.Inability to comply with the treatment regimen or follow-up assessments; 8.Severe cognitive or language impairments.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Pittsburgh Sleep Quality Index; | — |
Secondary
| Measure | Time frame |
|---|---|
| Pittsburgh Sleep Quality Index;Richards-Campbell Sleep Questionnaire;Rapid Eye Movement;Non-Rapid Eye Movement;Sleep efficiency; | — |
Countries
China
Contacts
Shandong Second People's Hospital (Shandong Provincial ENT Hospital, Shandong Provincial Institute of Otolaryngology)