Parkinson's disease
Conditions
Interventions
Parkinson's Disease with Sleep Disorders Group:All enrolled subjects will receive daridorexant tablets 50 mg orally 30 minutes before bedtime, with at least 7 hours remaining until their planned wake
Sponsors
The Second Affiliated Hospital of Hainan Medical University
Eligibility
Sex/Gender
All
Age
40 Years to 80 Years
Inclusion criteria
Inclusion criteria: 1. Age range: 40 - 80 years old. 2. Patients diagnosed with Parkinson's disease according to the clinical diagnostic criteria of the Movement Disorder Society (MDS) of the International Parkinson and Movement Disorders Association. 3. Hoehn & Yahr staging: I - III stage. 4. Meet the diagnostic criteria for chronic insomnia disorder as defined in the International Classification of Sleep Disorders, 3rd edition (ICSD-3), with a complaint of insomnia lasting for >= 3 months, and the main feature being difficulty in maintaining sleep (total wake time after sleep onset, WASO > 30 minutes). 5. Have received stable doses (>= 4 weeks) of anti-PD drugs. 6. Have signed a written informed consent form.
Exclusion criteria
Exclusion criteria: 1. Secondary Parkinsonism or Parkinsonian superimposed syndrome (such as Multiple System Atrophy, MSA; Progressive Supranuclear Palsy, PSP; Dementia with Lewy Bodies, DLB). 2. The main cause of sleep disorders other than severe insomnia (such as uncontrolled obstructive sleep apnea, OSA), or the presence of progressive rapid eye movement sleep behavior disorder (REM sleep behavior disorder, RBD) requires further assessment; or those who are currently using benzodiazepines/other potent sedative-hypnotic drugs for a long time and cannot safely discontinue them. 3. Regular use of prescription drugs that may affect sleep (more than 3 times per week) before enrollment. 4. Severe cognitive impairment (Mini-Mental State Examination, MMSE total score < 10). 5. Presence of severe or unstable mental disorders, other neurological diseases or physical diseases. 6. Pregnant/lactating or having other conditions that make participation in this study inappropriate. 7. Known allergy to the components of Dalirex.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Wake After Sleep Onset(WASO);Sleep onset latency;Parkinson’s Disease Questionnaire – 39; | — |
Secondary
| Measure | Time frame |
|---|---|
| Subjective total sleep time;Sleep efficiency;Motor Function (MDS-UPDRS-III);Insomnia Severity Index;Incidence rate of fall events;Cognitive Function (MOCA, MMSE);Sleep Quality (Parkinson's Disease Sleep Scale, PDSS);Biomarkers (e.g., GFAP, NfL); | — |
Countries
China
Contacts
Public ContactYou Yong;Luan Jiajie
The Second Affiliated Hospital of Hainan Medical University
Outcome results
None listed