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Clinical study of wearable transcutaneous acupoint electrical stimulation device for the treatment of insomnia disorders

Clinical study of wearable transcutaneous acupoint electrical stimulation device for the treatment of insomnia disorders

Status
Active, not recruiting
Phases
Early Phase 1
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2400088141
Enrollment
Unknown
Registered
2024-08-12
Start date
2024-09-01
Completion date
Unknown
Last updated
2024-08-19

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

Conditions

insomnia

Interventions

Experimental group: transcutaneous acupoint electrical stimulation and Sleep hygiene education

Sponsors

Binhai New Area Hospital of Traditional Chinese Medicine.Tianjin
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 65 Years

Inclusion criteria

Inclusion criteria: (1) Meet the diagnostic criteria for chronic insomnia in the International Classification of Sleep Disorders, 3rd Edition (ICSD-3); (2) Age range: 18-65 years old, male or female; (3) The Pittsburgh Sleep Quality Index score >7 points, the Hamilton Depression Scale score < 24 points, and the Hamilton Anxiety Scale score < 21 points; (4) Able to understand the content of the scale and cooperate with treatment, without communication disorder or cognitive impairment; (5) Voluntarily participate in the study, accept randomization and sign the informed consent form.

Exclusion criteria

Exclusion criteria: (1) Combined with serious primary diseases of the heart, brain, liver, kidney, and hematopoietic system; Patients with acute diseases, infectious diseases, and malignant tumors; (2) Substance addiction or abuse (such as drugs, alcohol, caffeine, etc.); (3) Patients with severe skin infection at the acupoint site; (4) Pregnant women.

Design outcomes

Primary

MeasureTime frame
Pittsburgh Sleep Quality Index Scale;

Secondary

MeasureTime frame
Insomnia Severity Index Scale;Hamilton Depression Scale-17;Hamilton Anxiety Scale-14;Heart rate variability;Near-infrared functional imaging of the brain;

Countries

China

Contacts

Public ContactGeng Lianqi

Binhai New Area Hospital of Traditional Chinese Medicine.Tianjin

genglianqi@163.com+86 139 2095 6132

Outcome results

None listed

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