Prevalence of Restless Legs Syndrome in Advanced Chronic Kidney Disease Patients: A Cross-Sectional Study

未提供1 个研究点分布在 1 个国家目标入组 231 人开始时间: 2025年12月21日最近更新: 2025年12月2日

试验速览

阶段: 不适用
状态: 尚未招募
入组人数: 231
试验地点: 1

研究概览研究设计入排标准研究者研究点记录与标识符相似试验

研究概览

简要总结

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.

研究设计

研究类型: Observational

入排标准

年龄范围: 18.00 Year(s) 至 90.00 Year(s)（—）
性别: All

入选标准

•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.

排除标准

•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.

研究者

发起方

未提供

责任方

Principal Investigator

主要研究者

Shravana N C

Kasturba Medical College, Manipal

研究点 (1)

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