Clinical Efficacy Analysis of Rupazolam Combined with Acupoint Magnetic Stimulation for Insomnia

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

ChiCTR

Registry ID

ChiCTR2600117150

Enrollment

Unknown

Registered

2026-01-20

Start date

2026-01-30

Completion date

Unknown

Last updated

2026-01-27

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

Conditions

Insomnia

Interventions

Control group:Right-sided Zopiclone combined with sham stimulation

Study group:Right-sided Zopiclone combined with acupoint magnetic stimulation

Eligibility

Sex/Gender

All

Age

18 Years to 80 Years

Inclusion criteria

Inclusion criteria: 1.Age range: 18 to 80 years old, no gender restrictions; 2.Meets the diagnostic criteria for insomnia as outlined in the Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-V); 3.Participants must have a Pittsburgh Sleep Quality Index (PSQI) score >=7 and an Insomnia Severity Index (ISI) score >7; 4.Informed consent must be signed by the participant or their family member.

Exclusion criteria

Exclusion criteria: 1.Suffering from central nervous system disorders; 2.Unable to cooperate with assessment and treatment; 3.Other sleep disorder types, including respiratory-related sleep disorders, restless legs syndrome, periodic limb movement disorder, circadian rhythm sleep-wake disorders (such as delayed sleep phase syndrome, environmental sleep difficulty, hypersomnia syndrome, etc.); 4.Presence of pacemakers within 30cm of the treatment site or intracranial metallic implants; 5.Severe cervical spine pathology including significant cervical spinal canal stenosis or cervical instability; 6.Direct injury to the stimulation site or cranial defects; 7.Pregnant or lactating women; 8.Dependence on or abuse of alcohol, drugs, or other psychoactive substances, including caffeine; 9.Insomnia caused by moderate or severe anxiety or depressive disorders (SAS standard score >=61, SDS standard score >=63); 10.Presence of other severe psychiatric disorders with psychiatric medication use within one month prior to study entry; 11.Contraindications for zopiclone include any of the following: hypersensitivity to this product or any of its constituents; patients with decompensated respiratory insufficiency; myasthenia gravis; patients with severe sleep apnoea syndrome.

Design outcomes

Primary

Measure	Time frame
Pittsburgh Sleep Quality Index;	—

Secondary

Measure	Time frame
Self-Rating Depression Scale;Changes in whole-brain d, ?, a, and ß frequency band power values;Insomnia Severity Index;Anxiety Self-Assessment Scale;	—

Countries

China

Contacts

Public ContactGong Xiaoyang

The First Affiliated Hospital of Dalian Medical University

gongxiaoyang@firsthosp-dmu.com+86 411 83635963

Outcome results

None listed

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