A study on the neural mechanism of traditional Chinese medical relaxing and calming exercise to reduce the level of cortical arousal in patients with insomnia
- Conditions
- Insomnia
- Registration Number
- ITMCTR2200005685
- Lead Sponsor
- China Academy of Chinese Medical Science Guang'anmen Hospital
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Pending
- Sex
- All
- Target Recruitment
- Not specified
1)It meets the diagnostic criteria of DSM-V primary insomnia, Insomnia severity Index scale(ISI) =15,or Pittsburgh Sleep Quality Index(PSQI) =7
2)Ages 20-60
3)No antidepressants, anxiolytics, antipsychotics and hypnotics were taken in recent 1 month.
4)No contraindications of MRI scanning (No metallic implants, right-handed )
5)Education level above junior high school
1)History of brain organic diseases
2)Perimenopausal, pregnant and lactating women
3)Persons with severe physical diseases
4)Suicidal concept or suicidal behavior
5)History of meditation and qigong practice
6)Contraindications of MRI scanning: ? patients with cardiac pacemaker, nerve stimulator, artificial metal heart valve, etc.; ? patients with aneurysm clip (excluding nonparamagnetic titanium alloy); ? patients with intraocular metal foreign bodies, inner ear implantation, metal prosthesis, metal prosthesis, metal joint, ferromagnetic and other foreign bodies; ? patients with severe hyperthermia; ? patients with claustrophobia; ? craniocerebral diseases Trauma, idiopathic epilepsy
7)Radionuclide examination or transcranial magnetic stimulation within 6 month.
Study & Design
- Study Type
- Interventional study
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Pittsburgh Sleep Quality Index(PSQI);Functional Magnetic Resonance Imaging(fMRI); Insomnia severity Index scale(ISI);Polysomnography(PSG);
- Secondary Outcome Measures
Name Time Method Ruminative Responses Scale(RRS);salivary cortisol;the Mindful Attention Awareness Scale(MAAS);Automatic Thinking;Hamilton Anxiety Scale (HAMA);Mind Wandering;Hamilton Depression Scale(HAMD);