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Study on the effectiveness of transcranial AC stimulation in the treatment of primary insomnia assisted by accurate simulation positioning calculation

Study on the effectiveness of transcranial AC stimulation in the treatment of primary insomnia assisted by accurate simulation positioning calculation

Status
Active, not recruiting
Phases
Early Phase 1
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2100042384
Enrollment
Unknown
Registered
2021-01-21
Start date
2021-03-01
Completion date
Unknown
Last updated
2021-04-26

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

Conditions

Insomnia

Interventions

True stimulation test group:tACS true stimulation+accurate simulation positioning calculation assistance
Pseudostimulation control group:tACS pseudo-stimulus+accurate simulation positioning calculation assistance

Sponsors

Aerospace Center Hospital, Peking University Aerospace School of Clinical Medicine
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 65 Years

Inclusion criteria

Inclusion criteria: In the healthy group: 1. Aged 18-65 years; 2. No history of sleep disorders; 3. PSQI < 7; 4. Good sleep quality, no history of working day and night alternately; 5. No neurological or mental illness, such as depression and anxiety (HAMD <= 7, HAMA < 7); 6. No other sleep disorder; 7. Right handed. Patients with primary insomnia group: 1. Accord with the diagnostic criteria of insomnia, right-handed; 2. The patient is conscious, has no aphasia and intelligence disorder, can understand the scale content and cooperate with the treatment; 3. The total score of Pittsburgh sleep quality index (PSQI) was more than or equal to 7; 4. No serious organic diseases, such as cardiovascular disease, liver and kidney insufficiency and psychosis; 5. Those who are 18-65 years old, willing to accept the treatment and insist on the treatment; 6. Volunteer and sign informed consent. 7. HAMA score <= 14; 8. HAMD score <= 17.

Exclusion criteria

Exclusion criteria: 1. Subjects who used other drugs to treat insomnia; 2. Subjects with insomnia caused by drugs, emergency events, environmental and psychological factors and bad habits; 3. Patients with severe neurasthenia, insomnia caused by stress disorder, personality disorder, organic diseases and psychoactive substances; 4. Subjects whose living environment (objective) will change greatly during the observation period; 5. Patients with severe hepatic and renal insufficiency or complicated with severe diseases of various systems; 6. Subjects who could not insist on treatment due to distance or other reasons; 7. Pregnant women, lactating women and other special groups; 8. According to the judgment of the researcher, there are other situations with low possibility of enrollment or complicating the enrollment, such as frequent travel, etc; Those who meet any of the above criteria are not eligible.

Design outcomes

Primary

MeasureTime frame
PSQI;

Secondary

MeasureTime frame
EEG;HAMA;HAMD;

Countries

China

Contacts

Public ContactWang Jing

Aerospace Center Hospital, Peking University Aerospace School of Clinical Medicine

happyksg@126.com+86 15910525655

Outcome results

None listed

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