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CTRI Number  CTRI/2025/12/098360 [Registered on: 03/12/2025] Trial Registered Prospectively
Last Modified On: 02/12/2025
Post Graduate Thesis  Yes 
Type of Trial  Observational 
Type of Study   Cross Sectional Study 
Study Design  Single Arm Study 
Public Title of Study   How common is Restless Leg Syndrome in people with severe kidney disease? 
Scientific Title of Study   Prevalence of Restless Legs Syndrome in Advanced Chronic Kidney Disease Patients: A Cross-Sectional Study 
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Shravana N C 
Designation  PhD Scholar 
Affiliation  Kasturba Medical College, Manipal 
Address  Room No 15, Department of Nephrology, Kasturba Medical College, Manipal, Manipal Academy of Higher Education, Manipal, Udupi, Karnataka, India

Udupi
KARNATAKA
576104
India 
Phone  9449342562  
Fax    
Email  shravana1.kmcmpl2024@learner.manipal.edu  
 
Details of Contact Person
Scientific Query  
Name  Dr Indu Ramachandra Rao 
Designation  Additional Professor 
Affiliation  Kasturba Medical College, Manipal 
Address  Room No 15, Department of Nephrology, Kasturba Medical College, Manipal, Manipal Academy of Higher Education, Manipal, Udupi, Karnataka, India

Udupi
KARNATAKA
576104
India 
Phone  9592896393  
Fax    
Email  indu.rao@manipal.edu  
 
Details of Contact Person
Public Query  
Name  Dr Indu Ramachandra Rao 
Designation  Additional Professor 
Affiliation  Kasturba Medical College, Manipal 
Address  Room No 15, Department of Nephrology, Kasturba Medical College, Manipal, Manipal Academy of Higher Education, Manipal, Udupi, Karnataka, India


KARNATAKA
576104
India 
Phone  9592896393  
Fax    
Email  indu.rao@manipal.edu  
 
Source of Monetary or Material Support  
Kasturba Hospital, Manipal 
 
Primary Sponsor  
Name  NIL 
Address  NIL 
Type of Sponsor  Other [NA] 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Indu Ramachandra Rao  Kasturba Hospital, Manipal  Room No. 15, Department of Nephrology, Kasturba Medical College, Manipal, Manipal Academy of Higher Education, Manipal, Karnataka, India
Udupi
KARNATAKA 		 9592896393

indu.rao@manipal.edu 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Kasturba Medical College and Kasturba Hospital Institutional Ethics Committee  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: N184||Chronic kidney disease, stage 4 (severe), (2) ICD-10 Condition: N185||Chronic kidney disease, stage 5, (3) ICD-10 Condition: N186||End stage renal disease,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Nil  Nil 
Intervention  Nil  Nil 
Intervention  Nil  Nil 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  90.00 Year(s)
Gender  Both 
Details  Eligible participants are adults aged 18 years or older diagnosed with advanced chronic kidney disease, specifically Stages 4 or 5, including both dialysis and non-dialysis patients. To be included, they must be able to complete the sleep disorder questionnaires and relevant clinical assessments. Importantly, each participant must provide written informed consent after understanding the study procedures and objectives. 
 
ExclusionCriteria 
Details  Individuals are excluded if they have previously undergone a kidney transplant or if they suffer from neurological disorders unrelated to Restless Legs Syndrome, such as Parkinson’s disease, multiple sclerosis, or non-CKD peripheral neuropathies. The study also excludes those with severe psychiatric illnesses that independently affect sleep, such as active psychosis or a severe major depressive episode. Additionally, patients who have recently (within the last six weeks) used medications known to induce or worsen Restless Legs Syndrome are not eligible. These medications include certain antipsychotics, antidepressants (SSRIs, SNRIs, TCAs), antiemetics, lithium, and some antihistamines. Finally, anyone with an active infection or currently hospitalized due to an acute illness is also excluded from participation. 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
To estimate the prevalence of Restless Legs Syndrome (RLS), diagnosed using the Modified Restless Legs Syndrome diagnostic questionnaire.  Baseline 
 
Secondary Outcome  
Outcome  TimePoints 
To identify independent clinical & biochemical predictors of RLS with a particular focus on anemia, iron status & dialysis modality  Baseline 
To describe the severity distribution of RLS using the International RLS Rating Scale (IRLS)  Baseline 
To assess the correlation between RLS severity (IRLS score)and health-related quality of life
(KDQOL-13), depression (PHQ-9), & sleep quality (PSQI) 		 Baseline 
 
Target Sample Size   Total Sample Size="231"
Sample Size from India="231" 
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" 
Phase of Trial   N/A 
Date of First Enrollment (India)   21/12/2025 
Date of Study Completion (India) Applicable only for Completed/Terminated trials 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Applicable only for Completed/Terminated trials 
Estimated Duration of Trial   Years="1"
Months="0"
Days="0" 
Recruitment Status of Trial (Global)   Not Yet Recruiting 
Recruitment Status of Trial (India)  Not Yet Recruiting 
Publication Details   N/A 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Response - NO
Brief Summary   This cross-sectional study aims to determine the prevalence of Restless Legs Syndrome (RLS) among adults with advanced chronic kidney disease (CKD stages 4 to 5) at a tertiary care center. Using validated questionnaires, including the mRLSDQ, IRLS, KDQOL13, PHQ9, and PSQI, the study will assess the presence, severity, and impact of RLS on quality of life, mood, and sleep. Clinical and biochemical factors such as anemia, iron status, and dialysis modality will be evaluated as potential predictors. The study involves 231 participants, requires no biological samples, and aims to fill gaps in Indian data to enhance the early detection and management of RLS in CKD patients. 
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