Skip to content

Clinical Verification Study on Digital TCM Meridian-Following Therapeutic Robot Based on Multi-Physical Field Regulation Technology for Insomnia

Clinical Verification Study on Digital TCM Meridian-Following Therapeutic Robot Based on Multi-Physical Field Regulation Technology for Insomnia

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ITMCTR
Registry ID
ITMCTR2025002207
Enrollment
Unknown
Registered
2025-11-17
Start date
2026-01-01
Completion date
Unknown
Last updated
2025-12-08

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

Conditions

insomnia

Interventions

Digital TCM Meridian-Following Therapeutic Robot group:Digital TCM Meridian-Following Therapeutic Robot Combined with Cognitive Behavioral Therapy for Insomnia (CBT-I)
Cognitive Behavioral Therapy for Insomnia (CBT-I) group:Cognitive Behavioral Therapy for Insomnia (CBT-I)

Sponsors

Beijing Hospital of Traditional Chinese Medicine, Capital Medical University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 60 Years

Inclusion criteria

Inclusion criteria: 1) Meet the diagnostic criteria for ID in the above-mentioned DSM-5 2) Aged 18–60 years 3) Pittsburgh Sleep Quality Index (PSQI) score = 8 4) Hamilton Anxiety Scale (HAMA) (14-item version) score 32 7) Education level of junior high school or above 8) Sufficient comprehension ability to complete the examinations and tests required for the study 9) The subject signs the informed consent form him/herself 10) No use of anti-anxiety, anti-depressant, or sleep medications in the past month

Exclusion criteria

Exclusion criteria: 1) Complicated with severe diseases of the heart, liver, kidneys, hematopoietic system, or other major systems; 2) Pregnant or lactating women; 3) Complicated with skin ulcers; 4) Complicated with hemorrhagic diseases (e.g., hemophilia); 5) Patients who have received treatment with similar digital TCM meridian-following therapeutic robots in the past 3 months, or who are undergoing physical therapy (including acupuncture, tuina massage, laser therapy, etc.) within the past 1 month; 6) Patients with alcoholism and/or abuse of or dependence on psychoactive substances or drugs (including sleeping pills); 7) Patients with psychiatric disorders; 8) Patients with poor compliance who cannot actively cooperate with examinations and treatment. Any patient who meets any of the above criteria will be excluded.

Design outcomes

Primary

MeasureTime frame
PSQI;

Secondary

MeasureTime frame
ISI;HAMA;SF-36;

Countries

China

Contacts

Public ContactBin Li

Beijing Hospital of Traditional Chinese Medicine, Capital Medical University

libin@bjzhongyi.com18910781852

Outcome results

None listed

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