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Research on Personalized Insomnia Intervention Plans Based on EEG Closed-Loop Feedback

Research on Personalized Insomnia Intervention Plans Based on EEG Closed-Loop Feedback

Status
Active, not recruiting
Phases
Early Phase 1
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2400093256
Enrollment
Unknown
Registered
2024-11-29
Start date
2024-12-01
Completion date
Unknown
Last updated
2024-12-02

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

Conditions

insomnia

Interventions

Five-Element Music Group:Customized sleep-aid music based on Traditional Chinese Medicine's Five-Element theory
Sleep-Aid Music Group:Traditional sleep-aid music (non-Five-Element), such as natural sounds and soothing melodies
Transcranial and Transauricular Electrical Stimulation Group:Transcranial electrical stimulation (tES) or transauricular vagus nerve stimulation (taVNS)
Visual Stimulation Group:Sleep-aid visual content, such as soothing natural scenes or gradient light effects
Tactile Stimulation Group:Tactile stimulation devices providing soothing sensations through vibrations or pressure

Sponsors

School of Design, Hunan University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 60 Years

Inclusion criteria

Inclusion criteria: (1) Insomniacs and healthy sleepers. (2) Insomnia patients: Insomnia Severity Index Scale (ISI) >15 points; healthy sleepers: Insomnia Severity Index Scale (ISI) <7 points. (3) Age 18-60 years old. (4) Good cognitive function and no impairment in activities of daily living. (5) No hearing loss and normal or corrected-to-normal vision.

Exclusion criteria

Exclusion criteria: (1) The patient has severe cardiovascular, liver, kidney, or hematopoietic system diseases. (2) Insomnia in patients is caused by neurological diseases such as stroke and Parkinson's disease. (3) Patient insomnia is caused by mental disorders including depression or anxiety. (4) Having a history of epilepsy or currently diagnosed with an uncontrollable seizure. (5) The patient took antidepressants or antipsychotics two weeks before the trial.

Design outcomes

Primary

MeasureTime frame
Pittsburgh sleep quality index, PSQI;Insomnia Severity Index, ISI;

Secondary

MeasureTime frame
EEG functional connectivity;Electroencephalogram (EEG);Age;Height;Weight;Blood Pressure;Body Temperature;Pulse;

Countries

China

Contacts

Public ContactHanling Zhang

School of Design, Hunan University

jt_hlzhang@hnu.edu.cn+86 731 8882 2405

Outcome results

None listed

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