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Clinical Study of Zhu's Scalp Acupuncture Combined with Auricular Acupressure for Post-Stroke Insomnia under AI-Based Portable Sleep Monitor Evaluation

Clinical Study of Zhu's Scalp Acupuncture Combined with Auricular Acupressure for Post-Stroke Insomnia under AI-Based Portable Sleep Monitor Evaluation

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
ITMCTR
Registry ID
ITMCTR2026000546
Enrollment
Unknown
Registered
2026-03-18
Start date
2025-08-18
Completion date
Unknown
Last updated
2026-03-30

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

Conditions

post-stroke insomnia,PSI

Interventions

Treatment Group??:The combined intervention consisted of Zhu's scalp acupuncture and auricular acupoint pressing. Scalp acupuncture was applied to the Frontal-Ding zone (, É Ding Dài) and the Temporal
Control Group:The control group received auricular acupoint pressing only. The intervention was applied to the following points: Shenmen (TF4), Heart (CO15), Sympathetic (AH6a), and Subcortex (AT4).

Sponsors

Zhuhai Hospital of Integrated Traditional Chinese and Western Medicine
Lead Sponsor

Eligibility

Sex/Gender
All
Age
40 Years to 80 Years

Inclusion criteria

Inclusion criteria: (1) Patients who meet both Chinese and Western medicine diagnostic criteria, and whose stroke duration is =1 year; (2) Age between 40 and 80 years old, regardless of gender; (3) No history of sleep disorders, anxiety, depression, or other mental symptoms before the stroke, and no use of sleep medications before or after the stroke, or discontinuation of such medications for at least one month; (4) Pittsburgh Sleep Quality Index (PSQI) score between 8 and 16, and Insomnia Severity Index (ISI) score between 10 and 21; (5) The subject or their family member has signed the informed consent form.

Exclusion criteria

Exclusion criteria: (1) Patients who do not meet the above diagnostic criteria and inclusion criteria, and who had insomnia symptoms before the onset of stroke; (2) Patients with increased or decreased sensory sensitivity; (3) Patients with severe cognitive impairment who are unable to cooperate with relevant examinations; (4) Pregnant or breastfeeding patients; (5) Patients allergic to Vaccaria seeds, acupuncture needles, or alcohol, or those with a fear of acupuncture, or those with skin lesions, bleeding, or infection at the application or acupuncture site; (6) Patients with infectious diseases such as hepatitis, tuberculosis, or pneumonia, or those with severe cardiopulmonary disease or severe dysphagia or speech impairment that prevents basic communication required for this study; (7) Patients simultaneously participating in other research projects.

Design outcomes

Primary

MeasureTime frame
AI Portable Sleep Monitor;

Secondary

MeasureTime frame
Pittsburgh Sleep Quality Index ,PSQI;Insomnia Severity Index ,ISI;Stroke-Specific Quality of Life Scale, SS-QOL;Hospital anxiety depression scale,HADS;

Countries

China

Contacts

Public ContactLiao Jinlian

Zhuhai Hospital of Integrated Traditional Chinese and Western Medicine

gilianliao@163.com18390860964

Outcome results

None listed

Source: ITMCTR (via WHO ICTRP) · Data processed: Apr 4, 2026