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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

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

Status
Active, not recruiting
Phases
Early Phase 1
Study type
Interventional
Source
ITMCTR
Registry ID
ITMCTR2200005685
Enrollment
Unknown
Registered
2022-03-08
Start date
2022-05-31
Completion date
Unknown
Last updated
2023-02-20

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Insomnia

Interventions

control group:muscle relaxation
intervention group:Traditional Chinese medicine Song Jing Gong

Sponsors

China Academy of Chinese Medical Science Guang'anmen Hospital
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 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

Exclusion criteria

Exclusion criteria: 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.

Design outcomes

Primary

MeasureTime frame
Pittsburgh Sleep Quality Index(PSQI);Functional Magnetic Resonance Imaging(fMRI); Insomnia severity Index scale(ISI);Polysomnography(PSG);

Secondary

MeasureTime frame
Ruminative Responses Scale(RRS);salivary cortisol;the Mindful Attention Awareness Scale(MAAS);Automatic Thinking;Hamilton Anxiety Scale (HAMA);Mind Wandering;Hamilton Depression Scale(HAMD);

Countries

China

Contacts

Public ContactLV XUEYU

China Academy of Chinese Medical Science Guang'anmen Hospital

yuyu1208@163.com18610605568

Outcome results

None listed

Source: ITMCTR (via WHO ICTRP) · Data processed: Feb 4, 2026