Study on the central mechanism and prediction of efficacy of acupuncture in the treatment of chronic insomnia disorder
- Conditions
- chronic insomnia disorder
- Registration Number
- ITMCTR2200005885
- Lead Sponsor
- Chengdu University of Traditional Chinese Medicine
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Pending
- Sex
- All
- Target Recruitment
- Not specified
1. Gender unlimited, right-handed;
2. Age: 18 years = age = 60 years;
3. Pittsburgh sleep quality index (PSQI) score > 7 and Montreal Cognitive Assessment (MoCA)=24;
4. Insomnia symptoms 3 times a week for more than 3 months: including difficulty falling asleep, not sleeping deep or waking early; Sleep disturbances cause clinically significant distress;
5. Not taking hypnotics and other psychotropic drugs within 2 weeks before enrollment;
6. Informed consent was signed by the patient himself or by his / her immediate family.
Note: patients who meet each of the above criteria may be included in this study.
1. History of disorders of consciousness;
2. Other types of sleep disorders, including sleep apnea syndrome, sleep related movement disorders, central sleep disorders, narcolepsy and sleep wake rhythm disorders, etc;
3. Combined severe heart, liver, kidney, brain and hematopoietic diseases;
4. Have a history of depression, bipolar disorder, schizophrenia and other psychiatric disorders;
5. Pregnant and lactating women; Those with willingness to conceive in nearly three months;
6. History of alcohol, drugs, coffee dependence;
7. Contraindications to MRI scanning such as electronic versus metallic device implantation.
Note: patients who met any of the above were excluded.
Study & Design
- Study Type
- Interventional study
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Pittsburgh sleep quality index;
- Secondary Outcome Measures
Name Time Method Self-rating Anxiety Scale;Montreal Cognitive Assessment;Hyperarousal scale;fatigue severity scale;Heart rate variablity;the insomnia severity index;Epworth sleepiness score;Self-Rating Depression Scale;