NCT04023201

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
1,500

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jul 2019

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 3, 2019

Completed
12 days until next milestone

First Submitted

Initial submission to the registry

July 15, 2019

Completed
2 days until next milestone

First Posted

Study publicly available on registry

July 17, 2019

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2019

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

January 31, 2020

Completed
Last Updated

July 17, 2019

Status Verified

July 1, 2019

Enrollment Period

6 months

First QC Date

July 15, 2019

Last Update Submit

July 15, 2019

Conditions

Outcome Measures

Primary Outcomes (1)

  • 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

Study Arms (1)

Parkinson's disease patients

Parkinson's disease patients with or without nocturnal symptoms

Other: Nocturnal symptoms

Interventions

Parkinson's disease patients with or without nocturnal symptoms

Parkinson's disease patients

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

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

You may qualify if:

  • Parkinson's disease patients diagnosed according to the diagnostic criteria of MDS
  • Signing informed consent

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Xinhua Hospital Affiliated to Shanghai Jiao Tong University School of Medicine

Shanghai, Shanghai Municipality, 200092, China

RECRUITING

Related Publications (1)

  • Grandas F, Iranzo A. Nocturnal problems occurring in Parkinson's disease. Neurology. 2004 Oct 26;63(8 Suppl 3):S8-11. doi: 10.1212/wnl.63.8_suppl_3.s8.

    PMID: 15505143BACKGROUND

MeSH Terms

Conditions

Parkinson Disease

Condition Hierarchy (Ancestors)

Parkinsonian DisordersBasal Ganglia DiseasesBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesMovement DisordersSynucleinopathiesNeurodegenerative Diseases

Study Officials

  • Zhenguo Liu, Doctor

    Xinhua Hospital, Shanghai Jiao Tong University School of Medicine

    STUDY CHAIR

Central Study Contacts

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 15, 2019

First Posted

July 17, 2019

Study Start

July 3, 2019

Primary Completion

December 31, 2019

Study Completion

January 31, 2020

Last Updated

July 17, 2019

Record last verified: 2019-07

Locations