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Clinical research on Ear-acupuncture stimulation for insomnia

Ear-acupuncture therapy for insomnia and the relationship between concha and vagus nerve

Status
Active, not recruiting
Phases
Phase 2
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR-TRC-13003519
Enrollment
Unknown
Registered
2013-08-09
Start date
2013-09-01
Completion date
Unknown
Last updated
2017-04-18

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

Conditions

Insomnia

Interventions

Ear vagus nerve stimulation group:The stimulator is placed at concha. Density wave is at 20Hz with less than 1ms’ wave width and 1-3mA current on auricular concha. The intensity is set according to du
Ear non vagus nerve stimulation group:The stimulator is placed at non concha(ear edge midpoint). The stimulation parameters and treatment is with the same as vagus nerve stimulation group.

Sponsors

Institute of Acupuncture-Moxibustion, China Academic of Chinese Medical Sciences
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 70 Years

Inclusion criteria

Inclusion criteria: 1. Primary insomnia: In accordance with the PRC pharmaceutical industry standards, Insomnia is almost the only symptom; Insomnia and insomnia with grave concern the advantages of the concept of the results; Patients with sleep quantity and quality are not satisfied, significant distress or social dysfunction; Occurred at least three times a week, has been going on for at least a month; Exclude people with physical illness or mental disorder symptoms; 2. Meet the above criteria and are diagnosed in patients diagnosed with insomnia; 3. Between the ages of 18-70 years of age, male or female; 4. Disease duration less than 6 months; 5. No significant immune dysfunction and genetic abnormalities, No serious cardiovascular and cerebrovascular disease; 6. Volunteers and signed informed consent.

Exclusion criteria

Exclusion criteria: 1. Patients who do not meet the inclusion criteria. 2. Pregnant women and people with severe heart, liver, kidney dysfunction; Patients who associated with blood diseases, cancer, respiratory, cardiovascular and cerebrovascular diseases, autoimmune diseases or extremely weak person; 3. With reduced enrolled the possibility or other diseases so that the enrolled complicate, such as frequent changes in the working environment could easily lead to lost stimulation.

Design outcomes

Primary

MeasureTime frame
Pittsburgh sleep quality index;

Secondary

MeasureTime frame
EEG;Sleep rate;Hamilton Depression Rating Scale 24;Hamilton Anxiety Scale 14;Related biochemical;Polysomnograph;

Countries

China

Contacts

Public ContactRong Pei-jing
drrongpj@163.com+86 010-64014411-2718

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 19, 2026