- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04023201
Nocturnal Symptoms and Quality of Life in Patients With Parkinson's Disease in Shanghai (NQPDSH)
July 15, 2019 updated by: Xinhua Hospital, Shanghai Jiao Tong University School of Medicine
This is a cross-sectional, retrospective clinical observation study focusing on the incidence and influencing factors of nocturnal symptoms in patients with Parkinson's disease.
Study Overview
Detailed Description
This study was a cross-sectional, retrospective clinical observation study investigating the incidence and influencing factors of nocturnal symptoms in patients with Parkinson's disease through the Parkinson's disease sleep-related scale.
At the same time, the effects of nocturnal symptoms on the quality of life of patients with Parkinson's disease were studied.
About 1,500 Parkinson's patients will be recruited into the study who come from Shanghai, China.
Study Type
Observational
Enrollment (Anticipated)
1500
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Yu Zhang
- Phone Number: 8613916006909
- Email: zhangyu0330@126.com
Study Locations
-
-
Shanghai
-
Shanghai, Shanghai, China, 200092
- Recruiting
- Xinhua Hospital Affiliated to Shanghai Jiao Tong University School of Medicine
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Sampling Method
Probability Sample
Study Population
Parkinson's disease patients diagnosed according to the diagnostic criteria of MDS
Description
Inclusion Criteria:
- Parkinson's disease patients diagnosed according to the diagnostic criteria of MDS
- Signing informed consent
Exclusion Criteria:
- clinically suspected Parkinson's disease, has not been diagnosed;
- suspected or diagnosed as secondary Parkinson's syndrome (vascular, drug, traumatic, encephalitis, toxic, etc.);
- suspected or diagnosed as atypical Parkinson's syndrome (progressive supranuclear palsy, multiple system atrophy, cortical basal ganglia degeneration, etc.);
- There is a clear history of stroke, moderate to severe traumatic brain injury, hydrocephalus, brain surgery or history of brain tumors;
- severe cognitive impairment or psychiatric symptoms;
- Can not cooperate with the completion of the study.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
---|---|
Parkinson's disease patients
Parkinson's disease patients with or without nocturnal symptoms
|
Parkinson's disease patients with or without nocturnal symptoms
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
nocturnal symptoms in patients with Parkinson's disease
Time Frame: January 31, 2020
|
the incidence and influencing factors of nocturnal symptoms in patients with Parkinson's disease
|
January 31, 2020
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Study Chair: Zhenguo Liu, Doctor, Xinhua Hospital, Shanghai Jiao Tong University School of Medicine
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
July 3, 2019
Primary Completion (Anticipated)
December 31, 2019
Study Completion (Anticipated)
January 31, 2020
Study Registration Dates
First Submitted
July 15, 2019
First Submitted That Met QC Criteria
July 15, 2019
First Posted (Actual)
July 17, 2019
Study Record Updates
Last Update Posted (Actual)
July 17, 2019
Last Update Submitted That Met QC Criteria
July 15, 2019
Last Verified
July 1, 2019
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- XHEC-C-2019-094
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
UNDECIDED
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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