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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT04023201
Other study ID # XHEC-C-2019-094
Secondary ID
Status Recruiting
Phase
First received
Last updated
Start date July 3, 2019
Est. completion date January 31, 2020

Study information

Verified date July 2019
Source Xinhua Hospital, Shanghai Jiao Tong University School of Medicine
Contact Yu Zhang
Phone 8613916006909
Email zhangyu0330@126.com
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

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.


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.


Recruitment information / eligibility

Status Recruiting
Enrollment 1500
Est. completion date January 31, 2020
Est. primary completion date December 31, 2019
Accepts healthy volunteers No
Gender All
Age group N/A and older
Eligibility Inclusion Criteria:

1. Parkinson's disease patients diagnosed according to the diagnostic criteria of MDS

2. Signing informed consent

Exclusion Criteria:

1. clinically suspected Parkinson's disease, has not been diagnosed;

2. suspected or diagnosed as secondary Parkinson's syndrome (vascular, drug, traumatic, encephalitis, toxic, etc.);

3. suspected or diagnosed as atypical Parkinson's syndrome (progressive supranuclear palsy, multiple system atrophy, cortical basal ganglia degeneration, etc.);

4. There is a clear history of stroke, moderate to severe traumatic brain injury, hydrocephalus, brain surgery or history of brain tumors;

5. severe cognitive impairment or psychiatric symptoms;

6. Can not cooperate with the completion of the study.

Study Design


Related Conditions & MeSH terms


Intervention

Other:
Nocturnal symptoms
Parkinson's disease patients with or without nocturnal symptoms

Locations

Country Name City State
China Xinhua Hospital Affiliated to Shanghai Jiao Tong University School of Medicine Shanghai Shanghai

Sponsors (1)

Lead Sponsor Collaborator
Xinhua Hospital, Shanghai Jiao Tong University School of Medicine

Country where clinical trial is conducted

China, 

References & Publications (1)

Grandas F, Iranzo A. Nocturnal problems occurring in Parkinson's disease. Neurology. 2004 Oct 26;63(8 Suppl 3):S8-11. Review. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary nocturnal symptoms in patients with Parkinson's disease the incidence and influencing factors of nocturnal symptoms in patients with Parkinson's disease January 31, 2020
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