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出境医 / 临床实验 / Nocturnal Symptoms and Quality of Life in Patients With Parkinson's Disease in Shanghai (NQPDSH)

Nocturnal Symptoms and Quality of Life in Patients With Parkinson's Disease in Shanghai (NQPDSH)

Study Description
Brief 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.

Condition or disease Intervention/treatment
Parkinson's Disease Other: Nocturnal symptoms

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 Design
Layout table for study information
Study Type : Observational
Estimated Enrollment : 1500 participants
Observational Model: Case-Only
Time Perspective: Cross-Sectional
Official Title: Nocturnal Symptoms and Quality of Life in Patients With Parkinson's Disease in Shanghai
Actual Study Start Date : July 3, 2019
Estimated Primary Completion Date : December 31, 2019
Estimated Study Completion Date : January 31, 2020
Arms and Interventions
Group/Cohort Intervention/treatment
Parkinson's disease patients
Parkinson's disease patients with or without nocturnal symptoms
 Other: Nocturnal symptoms
Parkinson's disease patients with or without nocturnal symptoms
Outcome Measures
Primary Outcome Measures :
  1. 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


Eligibility Criteria
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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
Parkinson's disease patients diagnosed according to the diagnostic criteria of MDS
Criteria

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.
Contacts and Locations

Contacts
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Contact: Yu Zhang 8613916006909 zhangyu0330@126.com

Locations
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China, Shanghai
Xinhua Hospital Affiliated to Shanghai Jiao Tong University School of Medicine Recruiting
Shanghai, Shanghai, China, 200092
Contact: Yu Zhang, Doctor    8613916006909    zhangyu0330@126.com   
Sponsors and Collaborators
Xinhua Hospital, Shanghai Jiao Tong University School of Medicine
Investigators
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Study Chair: Zhenguo Liu, Doctor Xinhua Hospital, Shanghai Jiao Tong University School of Medicine
Tracking Information
First Submitted Date July 15, 2019
First Posted Date July 17, 2019
Last Update Posted Date July 17, 2019
Actual Study Start Date July 3, 2019
Estimated Primary Completion Date December 31, 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: July 15, 2019) 		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
Original Primary Outcome Measures Same as current
Change History No Changes Posted
Current Secondary Outcome Measures Not Provided
Original Secondary Outcome Measures Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Nocturnal Symptoms and Quality of Life in Patients With Parkinson's Disease in Shanghai
Official Title Nocturnal Symptoms and Quality of Life in Patients With Parkinson's Disease in Shanghai
Brief 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.
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
Study Design Observational Model: Case-Only
Time Perspective: Cross-Sectional
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
Sampling Method Probability Sample
Study Population Parkinson's disease patients diagnosed according to the diagnostic criteria of MDS
Condition Parkinson's Disease
Intervention Other: Nocturnal symptoms
Parkinson's disease patients with or without nocturnal symptoms
Study Groups/Cohorts Parkinson's disease patients
Parkinson's disease patients with or without nocturnal symptoms
Intervention: Other: Nocturnal symptoms
Publications * Grandas F, Iranzo A. Nocturnal problems occurring in Parkinson's disease. Neurology. 2004 Oct 26;63(8 Suppl 3):S8-11. Review.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Recruiting
Estimated Enrollment
 (submitted: July 15, 2019) 		1500
Original Estimated Enrollment Same as current
Estimated Study Completion Date January 31, 2020
Estimated Primary Completion Date December 31, 2019   (Final data collection date for primary outcome measure)
Eligibility Criteria

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.
Sex/Gender
Sexes Eligible for Study: All
Ages Child, Adult, Older Adult
Accepts Healthy Volunteers No
Contacts
Contact: Yu Zhang 8613916006909 zhangyu0330@126.com
Listed Location Countries China
Removed Location Countries  
 
Administrative Information
NCT Number NCT04023201
Other Study ID Numbers XHEC-C-2019-094
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement
Plan to Share IPD: Undecided
Responsible Party Xinhua Hospital, Shanghai Jiao Tong University School of Medicine
Study Sponsor Xinhua Hospital, Shanghai Jiao Tong University School of Medicine
Collaborators Not Provided
Investigators
Study Chair: Zhenguo Liu, Doctor Xinhua Hospital, Shanghai Jiao Tong University School of Medicine
PRS Account Xinhua Hospital, Shanghai Jiao Tong University School of Medicine
Verification Date July 2019

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