UMIN-CTR Clinical Trial

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
Last 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
1st 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