Parkinson's DiseaseNQPDSHNCT04023201
Nocturnal Symptoms and Quality of Life in Patients With Parkinson's Disease in Shanghai
An observational study of Parkinson's Disease, run by Xinhua Hospital, Shanghai Jiao Tong University School of Medicine at 1 site in China.
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. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Parkinson's Disease
- What is being tested?
- Nocturnal symptoms
- How many people
- 1,500 participants
- Where
- 1 siteChina
- Study dates
- 3 Jul 2019to 31 Jan 2020
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Parkinson's disease patients diagnosed according to the diagnostic criteria of MDS
Who may be able to join
- Parkinson's disease patients diagnosed according to the diagnostic criteria of MDS
- Signing informed consent
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Xinhua Hospital Affiliated to Shanghai Jiao Tong University School of Medicine
Shanghai, Shanghai Municipality, 200092
Yu Zhang, Doctor, 8613916006909, zhangyu0330@126.com
About this study
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.
Read the 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.
- Conditions
- Parkinson's Disease
- Being tested
- Nocturnal symptoms
- Medical subject headings
- Parkinson Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Nocturnal symptomsOther
Parkinson's disease patients with or without nocturnal symptoms
| Study group | Role | What they receive |
|---|---|---|
| Parkinson's disease patients | Parkinson's disease patients with or without nocturnal symptoms Receives: Other: Nocturnal symptoms |
What is being measured
The primary outcome is the main question the study is designed to answer.
nocturnal symptoms in patients with Parkinson's disease
the incidence and influencing factors of nocturnal symptoms in patients with Parkinson's disease
Measured: January 31, 2020
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Jul 2019
- Study start3 Jul 2019
- Primary completion31 Dec 2019 (estimated)
- Study completion31 Jan 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Parkinson's DiseaseStudies of the same condition, open and under way.
- More trials run by Xinhua Hospital, Shanghai Jiao Tong University School of MedicineThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Cross-sectional
- Enrolment
- 1,500 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Zhenguo Liu, Doctor, Study chair, Xinhua Hospital, Shanghai Jiao Tong University School of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04023201
- Sponsor's protocol ID
- XHEC-C-2019-094
- Acronym
- NQPDSH
- Status last verified
- Jul 2019
- First submitted
- 15 Jul 2019
- Last updated
- 17 Jul 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
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.
PubMed 15505143
Study at a glance
From the registry record, last updated by the sponsor on 17 Jul 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Nocturnal Symptoms and Quality of Life in Patients With Parkinson's Disease in Shanghai
- ClinicalTrials.gov ID
- NCT04023201
- Acronym / sponsor ID
- NQPDSH / XHEC-C-2019-094
- Conditions
- Parkinson's Disease
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 1,500 participants (estimated)
- Lead sponsor
- Xinhua Hospital, Shanghai Jiao Tong University School of MedicineUniversity, hospital or other
- Study start
- 3 Jul 2019 (actual)
- Primary completion
- 31 Dec 2019 (estimated)
- Study completion
- 31 Jan 2020 (estimated)
- First posted
- 17 Jul 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Case only
- Time perspective
- Cross-sectional
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Parkinson's disease patients | – | Other: Nocturnal symptomsParkinson's disease patients with or without nocturnal symptoms |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Parkinson's disease patients diagnosed according to the diagnostic criteria of MDS
Key inclusion criteria (2 listed)
- Parkinson's disease patients diagnosed according to the diagnostic criteria of MDS
- Signing informed consent
Key exclusion criteria (6 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Nocturnal symptomsParkinson's disease patients with or without nocturnal symptoms | Other | Parkinson's disease patients |
Primary outcome
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
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Jul 2019.
- Background: PubMed 15505143Grandas 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.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Zhenguo Liu, Doctor study chair
Xinhua Hospital, Shanghai Jiao Tong University School of Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Parkinson's Disease, run by Xinhua Hospital, Shanghai Jiao Tong University School of Medicine at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 17 Jul 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Yu Zhang (8613916006909, zhangyu0330@126.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
nocturnal symptoms in patients with Parkinson's disease (time frame: January 31, 2020). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04023201, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Jul 2019.