Health Condition 1: N184- Chronic kidney disease, stage 4 (severe) Health Condition 2: N185- Chronic kidney disease, stage 5 Health Condition 3: N186- End stage renal disease
Conditions
Interventions
Intervention1: Nil: Nil
Intervention2: Nil: Nil
Intervention3: Nil: Nil
Sponsors
NIL
Eligibility
Inclusion criteria
Inclusion criteria: 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.
Exclusion criteria
Exclusion criteria: 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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| To estimate the prevalence of Restless Legs Syndrome (RLS), diagnosed using the Modified Restless Legs Syndrome diagnostic questionnaire.Timepoint: Baseline | — |
Secondary
| Measure | Time frame |
|---|---|
| To identify independent clinical & biochemical predictors of RLS with a particular focus on anemia, iron status & dialysis modalityTimepoint: Baseline;To describe the severity distribution of RLS using the International RLS Rating Scale (IRLS)Timepoint: Baseline;To assess the correlation between RLS severity (IRLS score)and health-related quality of life (KDQOL-13), depression (PHQ-9), & sleep quality (PSQI)Timepoint: Baseline | — |
Countries
India
Contacts
Public ContactDr Indu Ramachandra Rao
Kasturba Medical College, Manipal
Outcome results
None listed