chronic insomnia
Conditions
Interventions
Sponsors
Eligibility
Inclusion criteria
Inclusion criteria: (1) Meet the diagnostic criteria for chronic insomnia according to ICSD-3; (2) Age between 18 and 65 years, right-handed; (3) Pittsburgh Sleep Quality Index (PSQI) score >7, ISI score =8; (4) Chief complaint of difficulty falling asleep, sleep latency =30 minutes, occurring at least 3 times per week for a duration of =3 months; (5) Willing to participate in the study and able to provide informed consent.
Exclusion criteria
Exclusion criteria: (1) Suffering from other sleep disorders such as obstructive sleep apnea syndrome, narcolepsy or restless legs syndrome; (2) Having a clearly diagnosed central nervous system disease such as dementia, epilepsy, Alzheimer's disease, cognitive impairment, Parkinson's disease, depression, anxiety disorder, etc.; (3) In the acute stage of underlying diseases that may affect insomnia, such as diabetes, hypertension, coronary heart disease, chronic nephritis, chronic pain, etc.; (4) Pregnant women; (5) Having received the Yanzhuan Jiuzhuan method or CBT-I treatment in the past; (6) Long-term shift workers; (7) Those who are currently participating in other clinical trials and have not completed them.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Pittsburgh Sleep Quality Index, PSQI; | — |
Secondary
| Measure | Time frame |
|---|---|
| Insomnia Severity Index, ISI;Pre-Sleep Arousal Scale, PSAS;Hospital Anxiety and Depression Scale, HADS;erceived Stress Scale, PSS;Hyperarousal Scale, HAS;Morningness-Eveningness Questionnaire, MEQ;Multidimensional Fatigue Inventory, MFI20;Gastrointestinal Symptom Rating Scale, GSRS;the 36-Item Short Form Health Survey, SF-36;Actigraphy;Peripheral Blood;Resting state functional magnetic resonance;Polysomnography monitoring throughout the night;Intestinal microbiota detection;sleep diary; | — |
Countries
China
Contacts
Shanghai municipal Hospital of Traditional Chinese Medicine Shanghai University of Traditional Chinese Medicine