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Clinical study of acupuncture on insomnia in Parkinson's disease

Clinical Efficacy and Mechanism Study of Jin's three-needle therapy for Parkinson's Insomnia

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ITMCTR
Registry ID
ITMCTR2025002431
Enrollment
Unknown
Registered
2025-12-10
Start date
2024-08-13
Completion date
Unknown
Last updated
2026-01-12

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

Conditions

parkinson disease

Interventions

Waiting group: Anti-Parkinson drugsd

Sponsors

The First Affiliated Hospital of Guangzhou University of Chinese Medicine
Lead Sponsor

Eligibility

Sex/Gender
All
Age
35 Years to 80 Years

Inclusion criteria

Inclusion criteria: (1) Meets diagnostic criteria for PD and insomnia, with insomnia onset occurring after PD diagnosis; (2) Male or female, aged 35–80 years; (3) Patient voluntarily participates in this study and signs written informed consent; (4) Pittsburgh Sleep Quality Index (PSQI) score >7; (5) Hoehn and Yahr staging of 1–3; (6) No use of adjunctive medications beyond stable baseline PD therapy; if used, a washout period (typically 3–7 days) must be completed before study inclusion.

Exclusion criteria

Exclusion criteria: (1) Patients with secondary Parkinson's disease, Parkinsonian syndromes, or other conditions suspected to be related to the patient's symptoms, such as Parkinson's superimposed syndromes or senile tremor; (2) Confirmed severe systemic diseases, such as stroke, malignant tumors, renal failure, diabetes, atrial fibrillation, etc.; (3) Patients with confirmed cortical sensory loss, ideomotor apraxia, or progressive aphasia; (4) Patients with severe cognitive impairment, blindness, deafness, or other conditions preventing adequate cooperation; (5) Patients with depression, severe anxiety disorders, psychotic states, schizophrenia, or other major psychiatric disorders; (6) Presence of other conditions or factors affecting sleep quality, such as drug, alcohol, or caffeine addiction; (7) Fear of acupuncture; (8) Refusal of anti-Parkinson's medication; (9) Acupuncture treatment contraindications: Individuals with concurrent severe life-threatening underlying conditions, or those with ulcers, abscesses, skin infections, or limb deficiencies at selected acupuncture points that preclude treatment. (10) Pregnant women or those planning pregnancy within 3 months; (11) Individuals who participated in other clinical trials involving drugs, acupuncture, or similar treatments within 1 month prior to study enrollment.

Design outcomes

Primary

MeasureTime frame
Pittsburgh Sleep Quality Index;

Secondary

MeasureTime frame
Parkinson's Disease Sleep Scale 2 ;Hamilton Anxiety Scale;Parkinson's Disease Questionnaire-39;Unified Parkinson's Disease Rating Scale;Sleep Diary;Adrenocorticotropic hormone;Cortisol;Corticotropin-releasing hormone;

Countries

china

Contacts

Public ContactLixing Zhuang

The First Affiliated Hospital of Guangzhou University of Chinese Medicine

ZhuangLixing@163.com13822287775

Outcome results

None listed

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