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The Application of Neuroregulation Techniques in Chronic Insomnia

The Application of Neuroregulation Techniques in Chronic Insomnia

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2600125962
Enrollment
Unknown
Registered
2026-06-01
Start date
2026-06-01
Completion date
Unknown
Last updated
2026-06-08

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

Conditions

Insomnia

Interventions

Healthy control group:None
The taVNS intervention group:The preferred stimulation site is the left auricle. The main site: the concha of the ear and the helix (the inner concave area of the ear). Electrode placement: Two electr
do not perform if there is any damage, inflammation, or eczema. Fix the ear clip-type electrode in the left concha area, make it fit tightly without loosening. After turning on the device, slowly incr
The tDCS intervention group:We selected the dorsolateral anterior frontal lobe on the left side as the target stimulation point. After the chronic insomnia patients completed the baseline neuro-psycho

Sponsors

the first people's hospital of hefei
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 65 Years

Inclusion criteria

Inclusion criteria: Inclusion criteria for patients with chronic insomnia (CID): 1. Age between 18 and 65 years old, with an educational level of >= 9 years (above junior high school); 2. Meeting the diagnostic criteria for CID disorder as specified in the 5th edition of the Diagnostic and Statistical Manual of Mental Disorders (DSM-5); 3. PSQI score >= 7; 4. Persistent insomnia symptoms for more than three months, including difficulty falling asleep, poor sleep quality or early awakening; 5. No use of sleep medications or other psychotropic drugs within 2 weeks prior to enrollment; 6. HAMD score = 26 to exclude cognitive impairment. Inclusion criteria for healthy participants: 1. Physically healthy, without complaints of sleep disorders, emotional disorders, or cognitive impairments; 2. Normal neurological examination; 3. MMSE >= 26, HAMD <= 7; 4. Age, gender, and educational level matched with the patient group.

Exclusion criteria

Exclusion criteria: 1. History of consciousness disorders; 2. Previous history of other types of sleep disorders, such as sleep apnea, restless legs syndrome, periodic limb movement during sleep, or circadian rhythm sleep disorders (e.g., early sleep syndrome); 3. Currently using known drugs that cause insomnia (such as steroids); 4. Other medical histories: such as central nervous system infections, head injuries, epilepsy, multiple sclerosis, toxic metabolic diseases, Parkinson's disease, intracranial tumors, hypothyroidism, diabetes and other physical diseases; history of severe depression, bipolar disorder, severe anxiety disorder, schizophrenia, personality changes, etc.; 5. History of alcohol, drug, or coffee dependence; 6. Complicated with severe heart, liver, kidney, brain and hematopoietic system diseases; 7. MRI scan contraindications such as electronic and metal device implants.

Design outcomes

Primary

MeasureTime frame
Quality of sleep;Excessive arousal state;Transcranial Doppler ultrasound;Anxiety and depression score;resting-state functional MRI;

Secondary

MeasureTime frame
The Pittsburgh Sleep Quality Index (PSQI);EEG, ECG, brain color Doppler ultrasound indicators;

Countries

China

Contacts

Public ContactWang Yuting

the first people's hospital of hefei

328955054@qq.com+86 183 5694 6243

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Jun 11, 2026