Material and Method: We’ve included 47 patients newly diagnosed with primary restless legs syndrome and a control group of 67 participants. “Sociodemographic Data Form”, “International Restless Legs Syndrome Study Group Rating Scale for Severity of Restless Legs Syndrome”, “The Pittsburgh Sleep Quality Index”, and “The World Health Organization Quality of Life Instrument Short Form Turkish Version” were applied to the participants.

Results: Patient and control groups were similar in many fields in terms of sociodemographic variables. Patient group had significantly higher sleep problems and lower quality of life compared to the control group. There was no difference among the genders in the patient group in terms of severity of the symptom. Although the severity of the symptom was similar among the smokers and nonsmokers in the patient group, the smoker group had higher level of sleep problems. Severity of the symptom demonstrated a positive correlation with sleep, and negative correlation with quality of life.

Conclusion: Restless legs syndrome has negative effects on sleep and quality of life. Such effects are impacted by the severity of the symptom.

While RLS, which causes complaints that can be de-scribed as pain, numbness, twitching, itching, etc., was diagnosed by identifying the five criteria determined by The International Restless Legs Syndrome Study Group (IRLSSG), the requirements of insomnia or daytime symptoms were introduced by the International Classification of Sleep Disorders-Third Edition in 2014 ³. There are varying conclusion in the literature on the prevalence of RLS, and the prevalence varies in the range of 1-15% in the adult population ⁴.

It is known to cause sleep disorder due to symptoms becoming more apparent generally at nighttime ⁵. RLS is a clinical condition which can disrupt the nor-mal life functions as a frequent cause of sleep disorders ⁶. Causing various sleep problems such as sleep onset latency, frequent awakening, and daytime sleepiness, RLS was used to be referred to as a mild neurological disorder in the beginning, today, it is demonstrated that the disorder negatively impacts the quality of life with physical, psychological, and social effects ^2,7.

In this study, we’ve planned to investigate the effects of the disorder and its severity on sleep and quality of life in individuals diagnosed with RLS. It was desired to investigate whether sleep problems differed compared to the control group, whether sociodemographic variables affect sleep problems in RLS, whether sleep problems worsen according to RLS severity, whether the presence of RLS affects quality of life, and whether there is a relationship between RLS severity and quality of life.

Study inclusion criteria were determined as being at the age of 18 and older, nonexistence of an ongoing neuro-developmental disorder, and nonexistence of alcohol and/or substance abuse. Participants with known iron deficiency anemia, pregnancy, polyneuropathy, chronic kidney failure, oral contraceptive users, and participants receiving RLS treatment were excluded from the study. We’ve obtained Ethics Committee approval dated 09.01.2019 and numbered KAEK-85 for our study. Our study was carried out in accordance with the Declara-tion of Helsinki.

Data Collection Tools
Sociodemographic Data Form: This is a semi-structured evaluation tools created by the researchers prepared for the purpose of collecting general or RLS related demographical and sociocultural data of the participants.

International Restless Leg Syndrome Study Group (IRLSSG) Rating Scale for Severity of RLS (RLSSS): Developed by IRLSSG, this scale comprises of 10 questions, each having a score range of 0-4, in-tended to determine the severity of the disorder⁸Pittsburgh Sleep Quality Index (PSQI): Intended to evaluate the existence and severity of sleep problems over the last month and comprising 19 questions, PSQI is developed by Buyyse et al., and Turkish version is adapted by Ağargün et al ^9,10. The scale comprises seven subdomains of subjective sleep quality, sleep latency, sleep duration, sleep efficiency, sleep disorder, sleep medication, and daytime dysfunction. Total score of 5 and above indicates a clinically poor sleep quality at a significant level ^9,10.

The World Health Organization Quality of Life Instrument Short Form Turkish Version (WHOQOL-BREF-TR): Intended to evaluate the quality of life of the individuals over the last 15 days, this index is developed by the World Health Organiza-tion, and Turkish adaption is available ^11,12. While the original version comprises 26 questions, Turkish version has 27 questions. The index includes subdomains of physical health, psychological health, social relationships, and environmental health, and measures the satisfaction with general quality of life and health.

Statistical Method
Sample size and power analyzes were calculated using the G Power program. Data collected in the study were analyzed using SPSS (Statistical Package for the Social Sciences) for Windows 26 software (SPSS Inc., Chica-go, IL, USA). Continuous variables were expressed as mean±standard deviation, and categorical variables were expressed as counts and percentages. Kolmogorov-Smirnov Test was used to determine the compati-bility of continuous variables to normal distribution. Continuous variables did not manifest normal distribu-tion. Thus, Mann Whitney U Test was used for the comparison of quantitative data among two independ-ent groups, Kruskal-Wallis H Test was used for the comparison of quantitative data among multiple inde-pendent groups. Pearson Chi-square test was used for the comparison of categorical data. Pearson Correlation Test was used to evaluate the correlation level among the scales administered to the participants. Significance level was taken as p <0,05 in the statistical analyses.

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Table 1: Sociodemographic variables and intergroup comparisons.

Mean age of the patient group was 54. Patients were divided into two groups based on such value as <54 age and ≥54 age. Mean RLSSS scores of the two groups were 28,34±8,08 and 32,50±6,27, respectively. Groups were significantly different from one another in terms of RLSSS scores (p <0,05).

78,7% (n :37) of the patient group was female, and 21,3% (n :10) was male. While mean RLSSS score in the female group was 31,13±6,28, it was 28,00±10,79 in the male group. RLSSS scores were similar among the genders (p >0,05).

Total mean PSQI score in the female patient group 10,56±3,98, and 9,50±4,71 in the male patient group. There was no significant difference among the total PSQI scores of the patient group by gender (p >0,05).

38,3% (n :18) of the patient group was smokers, and 61,7% (n :29) was not regular smokers. While mean RLSSS scores of the smoker group was 32,11±5,56, it was 29,44±8,33 in the nonsmoker group. No signifi-cant difference was observed among the smokers and nonsmokers in terms of RLSSS scores (p <0,05). While the mean PSQI score of smokers was 12,83±3,74, the mean PSQI score of the nonsmokers was 8,79±3,58. There was significant difference among the groups (p <0,05).

Groups were compared in terms of RLSSS, WHOQOL-BREF-TR, PSQI index scores. Total RLSSS score manifested significant difference in the patient and control groups (p <0,001). WHOQOL-BREF-TR general quality of life, health satisfaction, and physical health sub-domain scores were identified as significantly higher in the control group (p <0,05). WHOQOL-BREF-TR psychological health, environ-mental health, and social relationships sub-domain scores were similar among the groups (p >0,05). Total score of PSQI index and all subdomain scores were significantly higher in the patient group (p <0,05) (Table 2).

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Table 2: Comparison of parameters by groups.

Analyzing the relationship between RLSSS and PSQI in terms of direction and level of correlation among the scales in the patient group; significant correlation in the positive direction was identified among the RLSSS and PSQI total score, subjective sleep quality, and sleep disorder sub-domains (Table 3). Analyzing the rela-tionship between RLSSS and WHOQO

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Table 3: Evaluation of correlations of scale scores in the patient groups.

L-BREF-TR; there was significant correlation in the negative direction among the RLSSS, WHOQOL-BREF-TR physical health, psychological health, gen-eral quality of life, and health satisfaction sub-domains (Table 3). Analyzing the relationship between PSQI and WHOQOL-BREF-TR; there was significant correlation in the negative direction among the subjective sleep quality and social relationships. No significant correlation was observed among sleep latency and WHOQOL-BREF-TR. We’ve observed significant correlation in the negative direction among all sub-domains of WHOQOL-BREF-TR except for shortened sleep duration and general quality of life. There was significant correlation in the negative direction among sleep efficiency and environmental health. There was significant correlation in the negative direction among all subdomains of WHOQOL-BREF-TR except for sleep disorder and general quality of life. There was significant correlation in the negative direction among the sub-domains of daytime dysfunction and physical health, environmental health, general quality of life, and health satisfaction. There was significant correla-tion in the negative direction among all subdomains of WHOQOL-BREF-TR except for total PSQI score and general quality of life (Table 3).

When the RLS severity of the patient population was grouped by RLSSS score, 10,6% (n :5) of the patient group had “moderate”, 31,9% (n :15) had “severe”, and 57,4% (n :27) had “very severe” RLS severity levels. Analyzing the relationship between the RLS severity groups and WHOQOL-BREF-TR; significant difference was identified among the groups in terms of phys-ical health and health satisfaction sub-domain scores (Table 4).

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Table 4: Comparison of WHOQOL and PSQI scores according to RLS (Restless legs syndrome) stages.

Analyzing the relationship between RLS severity groups and PSQI; we’ve observed significant differ-ence among sleep disorder sub-domain and RLS groups (p <0,05, H :8,405), however, the differences among other sub-domains and RLS groups were not at a significant level (Table 4). Patients were grouped in terms of sleep disorder severities by total PSQI scores. Patients with score PSQI<5 were evaluated as having mild, PSQI≥5 to <10 as moderate, and PSQI≥10 as severe sleep disorder. Accordingly, 42,6% (n :20) of the patients had moderate, and 57,4% (n :27) had se-vere sleep disorder. Analyzing the relationship between the severity of sleep disorder and WHOQOL-BREF-TR; patients with severe sleep disorder had poorer quality of life compared to patients with moderate sleep disorder. Such difference was at a statistically significant degree in all domains except for general quality of life (Table 5).

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Table 5: Comparison of WHOQOL scores according to sleep dis-turbance severity of patient groups.

While there are studies demonstrating increase preva-lence of RLS by aging ^14,15, there are also studies demonstrating that the prevalence of RLS is not related to age ^16-18. Despite the fact that there are numerous studies investigating the relationship between age and prevalence of RLS, there are not adequate number of studies that investigate the relationship of age and severity of RLS. In our study, we’ve identified the severity of RLS as significantly higher in old age group compared to non-old age group. This data needs to be supported by new studies.

Results obtained in the studies investigating the rela-tionship of RLS with gender mainly demonstrate that it is more frequent and severe in females compared to males ^5,19,20. Although we’ve observed higher RLSSS scores in female patients compared to male patients in our study, such difference was not statistically significant. Our study does not differ from the general literature in this context. It is believed that the low number of participants affects such outcome.

There are various studies that investigate the relationship between smoking and RLS. While some of such studies have identified the relationship between smok-ing and RLS ^21-23, some was unable to demonstrate such relationship ^24,25. It is observed that the cur-rent data on this subject is conflicting. Although we have not observed any significant difference among the smoker and nonsmoker patient groups in terms of se-verity of RLS in our study, it is compatible with other studies that are unable to demonstrate the relationship among the two groups. However, our finding which demonstrates higher sleep disorder in the smoker group compared to nonsmoker group suggests that there may be a relationship between smoking and RLS despite the fact that there is a possibility that it may be related to other health issues which smoking may have caused.

One of the key findings of our study was the fact that individuals diagnosed with RLS generally had lower quality of life compared to healthy volunteers and such difference was apparent in perception of physical health and general quality of life. Studies demonstrate that RLS generally lowers the quality of life ^26-28. However, in our study, we’ve observed that the domains of quality of life, physical health, and health satisfaction decreased significantly as the severity of RLS increased in the patient group. There are studies in the literature on the fact that the quality of life declines as the severity of RLS increases ^27,29,30. Our study shows similarity with the literature in these aspects.

Another significant finding in our study was the fact that individuals diagnosed with RLS had significantly higher scores in total PSQI and in all sub-domains compared to healthy volunteers. Sleep disorder was common particularly in moderate and severe RLS due to the fact that the symptoms in individuals diagnosed with RLS were mainly observed at nighttime ³¹. In literature, approximately 85% of RLS patients has disorders such as sleep latency, maintaining sleep, and sleep efficiency, and one out of every three patients reports severe sleep disorders ^32-34. Our study supports the literature in this context.

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