Effect of low frequency repetitive magnetic stimulation at Shenmen (HT7) on sleep quality in patients with chronic insomnia

Phase 1

• Conditions: chronic insomnia

• Registration Number: ITMCTR1900002710
• Lead Sponsor: Shaanxi Traditional Chinese Medicine Hospital

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 20 February 2023

Recruitment & Eligibility

• Status: Pending
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

1. Compliance with DSM-5 diagnostic criteria for insomnia.
2. Aged 18-65 years, including 18, 65, regardless of gender.
3. The course of insomnia was consistent with that of chronic insomnia (the course of insomnia was more than 3 months).
4. Insomnia severity index (ISI) > 7.
5 .Right-handed.
6. Sign the informed consent.

Exclusion Criteria

1. Insomnia associated with other mental disorders (depression, anxiety, essence, equivalence), physical diseases (pain, stroke, coronary heart disease, cancer, etc.).
2. Complicated with severe depression and anxiety (PHQ-9 depression screening (>=20); GAD-7 anxiety screening (>=19).
3. Insomnia caused by poor sleep hygiene.
4. Insomnia caused by jet lag and shift work.
5. Those at high risk of sleep apnea (Stop Bang Questionnaire (>3 items positive) were judged to be at high risk).
6. Patients with serious or unstable chronic diseases,such as hypertension,impairment of liver and kidney function,etc.
7. Dependence or abuse of substances such as alcohol and drugs.
8. Have a history of central nervous system diseases such as epilepsy,encephaloma, hemangioma,encephalitis and acute brain injury.
9. Pregnant or lactating women and those who plan to become pregnant in the near future.
10. Metal foreign bodies exist within 30cm of the treatment site, such as cochlear implants, built-in pulse generators,aneurysm clips,stents, etc.
11. Benzodiazepines taken within 2 weeks before admission.
12. Within one month before admission,the patients had been treated with TMS, TDCS, ECT and acupuncture regularly.
13. Severe audiovisual impairment can not cooperate with the completion of the researchers.

Study & Design

• Study Type: Interventional study
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Pittsburgh sleep quality index, PSQI;Insomnia severity index, ISI;

Secondary Outcome Measures

Name	Time	Method
Montreal Cognitive Assessment (MoCA);Baker Anxiety Inventory (BAI);Baker Depression Scale 2nd Edition (BDI-II);