Parkinson's disease-related insomnia
Conditions
Interventions
Control group:eszopiclone
Bailemian group:Bailemian combined with eszopiclone
Sponsors
The First Affiliated Hospital of Xi'an Jiaotong University
Eligibility
Sex/Gender
All
Age
60 Years to 80 Years
Inclusion criteria
Inclusion criteria: 1.Age 60–80 years, gender unrestricted; 2.Confirmed idiopathic Parkinson’s disease (PD) patients meeting the MDS clinical diagnostic criteria (Hoehn & Yahr stage I–III); 3.Stable anti-PD medication regimen for at least 4 weeks prior to enrollment, with no major adjustments expected during the study; 4.Chief complaint of insomnia for >=3 months, meeting the ICSD-3 diagnostic criteria for chronic insomnia disorder, and Pittsburgh Sleep Quality Index (PSQI) total score >7; 5.Voluntarily signed informed consent form.
Exclusion criteria
Exclusion criteria: 1. Secondary Parkinson's syndrome or overlapping Parkinson's syndrome. 2. Presence of other diseases that clearly cause insomnia (such as uncontrolled pain, severe sleep apnea syndrome (AHI > 15), restless legs syndrome, etc.). 3. Severe mental illness (such as major depression with suicide risk, schizophrenia) or severe cognitive impairment (MoCA 2 times the upper limit of normal, Cr > upper limit of normal). 7. Pregnant or breastfeeding women, or those planning pregnancy. 8. Any other condition that the researcher considers unsuitable for participation in this study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Difference in wakefulness after sleep onset (WASO); | — |
Secondary
| Measure | Time frame |
|---|---|
| Depressive symptoms;Sleep Latency;cognitive function;Anxiety symptoms;Motor symptoms of Parkinson's disease; | — |
Countries
China
Contacts
Public ContactMeng Zhang
The First Affiliated Hospital of Xi'an Jiaotong University
Outcome results
None listed