Back to resultsPeriodic Limb Movements Among Dialysis and Non-dialysis Chronic Kidney Disease Patients
Primary Purpose
The Aim of the Study Was to Screen Prevalence of Periodic Limb Movements Among Chronic Kidney Disease Patients
Status
Completed
Phase
Not Applicable
Locations
Egypt
Study Type
Interventional
Intervention
Polysomnography
Sponsored by
About this trial
This is an interventional diagnostic trial for The Aim of the Study Was to Screen Prevalence of Periodic Limb Movements Among Chronic Kidney Disease Patients
Eligibility Criteria
Inclusion Criteria:
- chronic kidney disease
Exclusion Criteria:
- diabetic, hepatic and chrest disease patients
Sites / Locations
- Aswan University Hospital
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Diagnostic Polysomnography
Arm Description
Outcomes
Primary Outcome Measures
Periodic limb movement
Screening the prevalence of periodic limb movement
Secondary Outcome Measures
Full Information
NCT ID
NCT05153616
First Posted
November 28, 2021
Last Updated
November 28, 2021
Sponsor
Aswan University Hospital
1. Study Identification
Unique Protocol Identification Number
NCT05153616
Brief Title
Periodic Limb Movements Among Dialysis and Non-dialysis Chronic Kidney Disease Patients
Official Title
Periodic Limb Movements Among Dialysis and Non-dialysis Chronic Kidney Disease Patients
Study Type
Interventional
2. Study Status
Record Verification Date
November 2021
Overall Recruitment Status
Completed
Study Start Date
May 1, 2017 (Actual)
Primary Completion Date
March 10, 2020 (Actual)
Study Completion Date
March 10, 2020 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Aswan University Hospital
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
Periodic leg movement disorder is defined as periodic episodes of repetitive limb movements during sleep that mainly occur in the lower limb, including the hips, knees and toes and sometimes affects the upper limb. It may be accompanied by frequent nocturnal arousals, and if so, this sleep disturbance may cause excessive daytime sleepiness. Chronic kidney disease patients are at risk of periodic leg movements and common causes are iron deficiency, anemia, raised serum calcium and central and peripheral nervous system disorders.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
The Aim of the Study Was to Screen Prevalence of Periodic Limb Movements Among Chronic Kidney Disease Patients
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
100 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Diagnostic Polysomnography
Arm Type
Experimental
Intervention Type
Diagnostic Test
Intervention Name(s)
Polysomnography
Intervention Description
Full night attended polysomnography to diagnose periodic limb movements
Primary Outcome Measure Information:
Title
Periodic limb movement
Description
Screening the prevalence of periodic limb movement
Time Frame
One night
10. Eligibility
Sex
All
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
chronic kidney disease
Exclusion Criteria:
diabetic, hepatic and chrest disease patients
Facility Information:
Facility Name
Aswan University Hospital
City
Aswan
Country
Egypt
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Periodic Limb Movements Among Dialysis and Non-dialysis Chronic Kidney Disease Patients
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