Parkinson’s disease with insomnia
Conditions
Interventions
Leborexant:None
Sponsors
Guangdong Provincial People's Hospital(Guangdong Academy of Medical Sciences)
Eligibility
Sex/Gender
All
Age
30 Years to 80 Years
Inclusion criteria
Inclusion criteria: 1.Age =30 and =80 years at the time of signing the informed consent form;gender unrestricted; 2.Patients diagnosed with idiopathic Parkinson’s disease (PD) according to the Movement Disorder Society (MDS) 2015 Revised Clinical Diagnostic Criteria for Parkinson’s Disease; 3.Hoehn & Yahr stage I–III, receiving a stable dose of anti-Parkinsonian medication for at least four weeks prior to enrollment, with no dose adjustments planned during the treatment period; 4.Meeting DSM-5 diagnostic criteria for chronic insomnia: experiencing insomnia symptoms on =3 nights per week for the past three months, with subjective complaints of shortened total sleep time (sTST 5); 5. Good sleep hygiene habits, ensuring at least seven hours of time in bed; 6.Capable of independently completing questionnaires and attending follow-up visits, and having signed a written informed consent form.
Exclusion criteria
Exclusion criteria: 1.Presence of severe or unstable cardiovascular, hepatic, renal, hematologic, endocrine, neurologic, or other systemic or organ diseases, as determined by the investigator (e.g., asthma, chronic obstructive pulmonary disease [COPD], chronic pain, thyroid disorders, diabetes mellitus, hypertension); 2.Presence of severe psychiatric disorders, as determined by the investigator (e.g., schizophrenia spectrum and other psychotic disorders, bipolar and related disorders, obsessive-compulsive and related disorders, somatic symptom disorders), or unstable depressive or anxiety disorders; 3.Current suicidal risk, as determined by the investigator, or a score =3 on the suicide item of the 17-item Hamilton Depression Rating Scale (HAMD-17); 4.Presence of dementia or other clearly defined cognitive impairment, as determined by the investigator (using the Mini-Mental State Examination [MMSE] cutoff values based on educational level: MMSE =20 for individuals with elementary school education or lower;MMSE =24 for individuals with middle school education or higher); 5.Presence of restless legs syndrome (RLS) severely impairing sleep quality or periodic limb movements during sleep, as determined by the investigator (International Restless Legs Syndrome Study Group Rating Scale [IRLS] score =16); 6.Presence of moderate-to-severe obstructive sleep apnea syndrome without standardized treatment, as determined by the investigator (STOP-BANG score =5 or Epworth Sleepiness Scale [ESS] score =16); 7.Confirmed diagnosis of narcolepsy, or presence of classic core symptoms of narcolepsy (e.g., excessive daytime sleepiness, cataplexy, sleep paralysis, hypnagogic hallucinations) without completion of standardized diagnostic evaluation; 8.Inability to discontinue other sedative-hypnotic medications or drugs known to significantly affect sleep during the study period; inability to discontinue physical therapies or systematic psychological therapies for insomnia; use of hypnotics, sedating antidepressants, or antipsychotics within the past week; 9. Prior standardized treatment with dual orexin receptor antagonists (DORAs) for insomnia with inadequate therapeutic response; 10.Prolonged daytime bed rest; 11.Pregnancy or lactation; 12.Participation in another clinical study; 13.Other medical or clinical conditions that, in the investigator’s judgment, may interfere with efficacy assessment or increase safety risks for the participant.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Pittsburgh Sleep Quality Index; | — |
Secondary
| Measure | Time frame |
|---|---|
| PSQI Scale: Daytime Functioning Subscale Score;Parkinson’s Disease Rating Scale-III Score and Parkinson’s Disease Quality of Life Questionnaire Score;Hamilton Depression Scale 17 items, HAMD-17 Score;EMG burst frequency, EMG burst duration, and EMG burst amplitude during REM sleep;Parkinson's Disease Sleep Scale-2 Score;Hamilton Anxiety Scale,HAMA Score;Epworth Sleepiness Scale Score;Rapid Eye Movement Sleep Behavior Disorder Questionnaire-Hong Kong Score;Insomnia Severity Index; | — |
Countries
China
Contacts
Public ContactLijuan Wang
Guangdong Provincial People's Hospital(Guangdong Academy of Medical Sciences)
Outcome results
None listed