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Effectiveness of Brain Entrainment and Negatively Charged Particle Treatment in Addressing Sleep Disturbance in Non-Inpatient Population

Effectiveness of Brain Entrainment and Negatively Charged Particle Treatment in Addressing Sleep Disturbance in Non-Inpatient Population

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2600119262
Enrollment
Unknown
Registered
2026-02-25
Start date
2026-02-26
Completion date
Unknown
Last updated
2026-03-02

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

Conditions

Sleep disorder

Interventions

Experimental group:In the sleep cabin, the intervention of synchronized brainwave resonance combined with negatively charged particle intervention is carried out once within 30 minutes to relax the mi
Control Group:In the sleep cabin, the same-looking but ineffective pseudo-devices were used for intervention. The environmental conditions were the same as those of the experimental group. Sleep relax

Sponsors

Zhongshan Hospital, Fudan University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to No maximum

Inclusion criteria

Inclusion criteria: 1.Family members accompanying inpatients receiving treatment in the Inpatient Ward of the International Medical Department at Zhongshan Hospital; or family members accompanying patients receiving infusion therapy in the Outpatient Clinic of the International Medical Department at Zhongshan Hospital; or health-check clients undergoing examinations at the Sheshan Campus of the Zhongshan Hospital Health Management Center. 2.Age >= 18 years. 3.No use of hypnotic/sleep medications within the past three months, and no plan to use hypnotic/sleep medications within one month during the study period. 4.Family caregivers or health-check clients who meet the DSM-5 diagnostic criteria for insomnia, presenting with difficulty initiating sleep, difficulty maintaining sleep, or early-morning awakening with inability to return to sleep, accompanied by daytime symptoms such as sleepiness, impaired concentration, mood disturbance, etc.

Exclusion criteria

Exclusion criteria: 1.Substance abuse, overuse of sleep medications, and conditions that impair cognitive functioning, such as dementia, schizophrenia, severe developmental disorders, Parkinson’s disease, and acquired brain injury. 2.Individuals with any implanted electronic medical therapeutic or assistive devices. 3.Individuals wearing or currently using electronic medical devices/instruments (e.g., ambulatory ECG/Holter monitor, “electronic kidney” [dialysis-related device], cochlear implant, etc.). 4.History of claustrophobia, or having had a major physical illness within the past 3 months. 5.Long-term use of medications that affect sleep (e.g., systemic corticosteroids/glucocorticoids).

Design outcomes

Primary

MeasureTime frame
PSQI score at Week 4;

Secondary

MeasureTime frame
Anxiety level at Week 4;Depression level at Week 4;

Countries

China

Contacts

Public ContactChen Dan;Huang Xiao

Zhongshan Hospital, Fudan University

chen.dan@zs-hospital.sh.cn+86 21 6404 1990

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Mar 14, 2026