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The clinical efficacy and bioelectrical characteristics of transcutaneous electrical auricular point stimulation at different frequencies in the treatment of insomnia: A clinical study

The clinical efficacy and bioelectrical characteristics of transcutaneous electrical auricular point stimulation at different frequencies in the treatment of insomnia: A clinical study

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ITMCTR
Registry ID
ITMCTR2024000683
Enrollment
Unknown
Registered
2024-11-11
Start date
2024-11-15
Completion date
Unknown
Last updated
2024-12-09

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

Conditions

chorionic insomnia

Interventions

3:Transcutaneous electrical auricular stimulation at 20/100Hz
2:Transcutaneous electrical auricular stimulation at 4/20Hz

Sponsors

Institute of Acupuncture and Moxibustion China Academy of Chinese Medical Sciences
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 65 Years

Inclusion criteria

Inclusion criteria: 1) meet the DSM-5 criteria for insomnia disorder; 2) duration of insomnia > 3 months; 3) Age of 18-65 years old right-handed regardless of gender; 4) Pittsburgh Sleep Quality Index (PSQI) score =8; 5) Hamilton Anxiety Scale (HAMA) =14 and Hamilton Depression Rating Scale (HAMD) =17; 6) have not taken any drugs or substances that may affect the nervous system in the past month and have not received acupuncture treatment; 7) can receive electrical auricular acupoint stimulation; 8) sign informed consent.

Exclusion criteria

Exclusion criteria: 1) complicated with serious physical diseases such as coronary heart disease malignant tumor renal failure etc. 2) combined with organic brain diseases; 3) combined with any other mental disorders personality disorders or psychoactive substance abuse or dependence; 4) patients who could not be eluted by using sleep AIDS or acupuncture; 5) pregnant and lactating women; 6) severely damaged ear skin; 7) Unwilling to sign the informed consent form.

Design outcomes

Primary

MeasureTime frame
Pittsburgh Sleep Quality Index;

Secondary

MeasureTime frame
SDS;Insomnia Severity Index;DBAS;HAMD-17;HAMA;Resting state EEG;Pittsburgh sleep Quality Index score response rate;Flinders Fatigue Scale;Epworth Sleepiness Scor;fNIRS;SAS;Peripheral blood omics analysis;

Countries

China

Contacts

Public ContactYanan Zhao

Institute of Acupuncture and Moxibustion China Academy of Chinese Medical Sciences

zynjiayou425@163.com18800107425

Outcome results

None listed

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