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Effect of Combined Transcranial Direct Current Stimulation and Estazolam on Sleep Quality in Patients with Herpes Zoster-Associated Pain and Insomnia: A Randomized Controlled Trial

Effect of Combined Transcranial Direct Current Stimulation and Estazolam on Sleep Quality in Patients with Herpes Zoster-Associated Pain and Insomnia: A Randomized Controlled Trial

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2600118750
Enrollment
Unknown
Registered
2026-02-10
Start date
2026-03-01
Completion date
Unknown
Last updated
2026-02-16

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

Conditions

Zoster-associated pain

Interventions

D1E1 group:Conventional regimen + tDCS real stimulation (anode—F3, cathode—F4) + eszopiclone
D0E1 group:tDCS sham stimulation + eszopiclone

Sponsors

The Affiliated Hospital of Xuzhou Medical University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to No maximum

Inclusion criteria

Inclusion criteria: 1. A diagnosis of zoster-associated pain (ZAP) meeting the criteria outlined in the Chinese Expert Consensus on the Diagnosis and Treatment of Herpes Zoster (2022 edition); 2. A diagnosis of insomnia according to the International Classification of Sleep Disorders, Third Edition (ICSD-3); 3. A total score of >5 on the Chinese version of the Pittsburgh Sleep Quality Index (PSQI), accompanied by significant daytime impairment (indicated by a score of >=2 on item 7 of the PSQI, 'Daytime Dysfunction'); 4. Age >=18 years;

Exclusion criteria

Exclusion criteria: 1. Presence of intracranial organic lesions or a history of craniocerebral trauma; 2. Current use of medications (e.g., naloxone) known to interfere with the analgesic effects of transcranial direct current stimulation (tDCS); 3. Coexisting acute or chronic pain attributable to other causes, such as gout, trauma, or post-surgical pain; 4. Diagnosis of a severe psychiatric disorder or chronic severe insomnia (defined as a condition lasting >3 months with an Insomnia Severity Index [ISI] score =22); 5. Comorbid sleep disorders, including sleep apnea, periodic limb movement disorder, parasomnias, or narcolepsy; 6. Significant dysfunction of vital organs (e.g., heart, liver, kidneys, or brain); 7. Presence of implanted medical devices, including cardiac pacemakers, brain stimulation devices, or intracranial metallic implants (e.g., aneurysm clips, cranial plates); 8. History of ventriculoperitoneal shunt placement; 9. Poorly controlled epilepsy; 10. Known allergy or severe adverse reactions to conventional antiviral drugs, central analgesics, or tricyclic antidepressants; 11. Cognitive impairment that precludes effective communication or independent completion of questionnaire assessments; 12. Conditions involving central nervous system depression or significant comorbidity, such as acute alcohol intoxication, impaired hepatic or renal function, myasthenia gravis, acute or predisposed angle-closure glaucoma, or severe chronic obstructive pulmonary disease; 13. Patient or family member refusal to participate in the study protocol;

Design outcomes

Primary

MeasureTime frame
Pittsburgh Sleep Quality Index;

Secondary

MeasureTime frame
Insomnia Severity Index;Patient Health Questionnaire-9 score;Sleep parameters measured by Fitbit Charge 2?;Brief Pain Inventory score;7-item Generalized Anxiety Disorder Scale score;Pain Numerical Rating Scale score;

Countries

China

Contacts

Public ContactChen Liping

The Affiliated Hospital of Xuzhou Medical University

1132927346@qq.com+86 137 7587 0371

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 19, 2026