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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000036626
Receipt No. R000041728
Scientific Title Prevalence of sleep-related problems and Sleep-related Characteristics among caregivers of Egyptian Parkinson's disease patients
Date of disclosure of the study information 2019/04/30
Last modified on 2019/04/30

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Basic information
Public title Prevalence of sleep-related problems and Sleep-related Characteristics among caregivers of Egyptian Parkinson's disease patients
Acronym sleep-related problems and Characteristics among caregivers of Egyptian Parkinson's disease patients
Scientific Title Prevalence of sleep-related problems and Sleep-related Characteristics among caregivers of Egyptian Parkinson's disease patients
Scientific Title:Acronym sleep-related problems and Characteristics among caregivers of Egyptian Parkinson's disease patients
Region
Africa

Condition
Condition cross-sectional analysis
Classification by specialty
Neurology
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 Here we aim to study characteristics and prevalence of sleep-related problems among caregivers of Egyptian PD patients
Basic objectives2 Others
Basic objectives -Others characteristics and prevalence of sleep-related problems among caregivers of Egyptian PD patients.
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes the prevalence of sleep-related problems among sample of caregivers of Egyptian PD patients
Key secondary outcomes correlation of clinical motor scales including H & Y scale and/or UPDRS in PD patients with severity of sleep-related problems among their caregivers.

Base
Study type Observational

Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
Interventions/Control_2
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10

Eligibility
Age-lower limit
18 years-old <=
Age-upper limit
50 years-old >=
Gender Male and Female
Key inclusion criteria PD patients with age above 50 years, of any gender, and caregivers with age above 18 years, of any gender were considered for inclusion
Key exclusion criteria Excluded from enrollment were caregiver participants of Vascular PD (VP) or Parkinson plus syndrome (PPS) patients, and caregiver participants who refused consent, or with known history of sleep disorders and/or medications, psychiatric disorders and/or medications and medical conditions causing sleep problem including -but not limited to- thyroid or hepatic disorders.
Target sample size 40

Research contact person
Name of lead principal investigator
1st name Wael
Middle name
Last name Ibrahim
Organization kasralainy hospital, faculty of medicine, cairo university
Division name Neurology
Zip code 11562
Address Cairo
TEL +201111919927
Email dr.wael_ezzat@residents.kasralainy.edu.eg

Public contact
Name of contact person
1st name Wael
Middle name
Last name Ibrahim
Organization Kasralainy hospital, Faculty of Medicine, Cairo University
Division name Neurology
Zip code 12411
Address 37 elhassan street, dokki
TEL +201111919927
Homepage URL
Email dr.wael_ezzat@yahoo.com

Sponsor
Institute Neurology department
kasralainy hospital, faculty of medicine, cairo university
Institute
Department

Funding Source
Organization N/A
Organization
Division
Category of Funding Organization Self funding
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization Kasralainy hospital, Faculty of Medicine, Cairo University
Address 37 elhassan street, dokki
Tel +201111919927
Email dr.wael_ezzat@yahoo.com

Secondary IDs
Secondary IDs NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW

Institutions
Institutions Kasralainy hospital, Faculty of Medicine, Cairo University

Other administrative information
Date of disclosure of the study information
2019 Year 04 Month 30 Day

Related information
URL releasing protocol
Publication of results Unpublished

Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description

Progress
Recruitment status Preinitiation
Date of protocol fixation
2019 Year 04 Month 30 Day
Date of IRB
2019 Year 04 Month 30 Day
Anticipated trial start date
2019 Year 05 Month 01 Day
Last follow-up date
2020 Year 05 Month 01 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information The study was conducted on Egyptian caregivers and their patients diagnosed with IPD according to UK Parkinson's Disease Society Brain Bank Clinical Diagnostic Criteria5 presented to movement disorders clinic at Kasralainy hospital in period from May 2019 to April 2020. Caregiver was defined in our study according to NCI Dictionary of Cancer Terms as the person who gives care to PD patient who need help taking care of themselves, and may be health professionals, family members, friends, social workers, or members of the clergy. They may give care at home or in a hospital or other health care setting.
Those PD patients with age above 50 years, of any gender, and caregivers with age above 18 years, of any gender were considered for inclusion. Excluded from enrollment were caregiver participants of Vascular PD (VP) or Parkinson plus syndrome (PPS) patients, and caregiver participants who refused consent, or with known history of sleep disorders and/or medications, psychiatric disorders and/or medications and medical conditions causing sleep problem including -but not limited to- thyroid or hepatic disorders.

Management information
Registered date
2019 Year 04 Month 30 Day
Last modified on
2019 Year 04 Month 30 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000041728

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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