Severity Of Restless Legs Syndrome Symptoms Research Articles

Investigating the Effect of Temperature Therapy on the Severity of Restless Legs Syndrome: Systematic Review and Meta-Analysis.

Background: Restless legs syndrome (RLS) is a sensorimotor disorder leading to disturbance of resting, discomfort, stress, and impaired daytime activity in the sufferers. The present systematic review and meta-analysis was conducted to determine the effect of temperature therapy on the severity of RLS.Methods: The electronic databases of Google Scholar, ProQuest, Scopus, PubMed, Web of Science, and State Inpatient Databases (SID) were searched from inception to August 2022. The Cochrane Collaboration's Risk of Bias Tool was used to check the quality of included studies. Meta-analysis was performed by calculating standardized mean differences (SMDs), using random effects model, and running Comprehensive Meta-Analysis (CMA) software version 2.Results: The included studies (n=6) comprised 177 participants, whose mean age was 49.85 years old. The results of the meta-analysis showed temperature therapy could reduce the severity of RLS (SMD=-1.520, 95% CI: -2.122 to -0.918). Regarding the source of heterogeneity, meta-regression results indicated the efficacy of the intervention in reducing the severity of RLS enhanced significantly by increasing the duration of the intervention in each session (β=-0.039, 95% CI -0.076 to -0.002, P<0.001). The results also showed increasing the duration (β=-0.039, 95% CI -0.076 to -0.002, P<0.001) and the temperature of the intervention in each session (β=-0.016, 95% CI -0.028 to -0.003, P<0.05) significantly enhanced the efficacy of the intervention in reducing the severity of RLS. The results also indicated that, among patients with underlying clinical conditions, the effectiveness of temperature therapy was higher in hemodialysis patients (β=-2.006, 95% CI -2.736 to -1.276, P<0.05).Conclusion: The present study findings suggested temperature therapy could mildly reduce the severity of RLS symptoms. It was also found that the highest efficacy of this intervention could be achieved when the higher temperature was used in fewer treatment sessions in hemodialysis patients. Based on our findings, this intervention can be included in the care plan of patients with RLS considering the settings described to achieve the highest efficacy.

A Comparative Investigation of Functional Connectivity Utilizing Electroencephalography in Insomnia Patients with and without Restless Leg Syndrome

The current study aimed to identify distinctive functional brain connectivity characteristics that differentiate patients with restless legs syndrome (RLS) from those with primary insomnia. Quantitative electroencephalography (QEEG) was employed to analyze connectivity matrices using the phaselocking value technique. A total of 107 patients with RLS (RLS group) and 17 patients with insomnia without RLS (primary insomnia group) were included in the study. Demographic variables were compared using t tests and chi-square tests, while differences in connectivity were examined through multiple analyses of covariance. Correlation analysis was conducted to explore the relationship between connectivity and the severity of RLS. The results indicated significant differences in the primary somatosensory cortex (F = 4.377, r = 0.039), primary visual cortex (F = 4.215, r = 0.042), and anterior prefrontal cortex (F = 5.439, r = 0.021) between the RLS and primary insomnia groups. Furthermore, the connectivity of the sensory cortex, including the primary somatosensory cortex (r = -0.247, p = 0.014), sensory association cortex (r = -0.238, p = 0.028), retrosplenial region (r = -0.302, p = 0.002), angular gyrus (r = -0.258, p = 0.008), supramarginal gyrus (r = -0.230, p = 0.020), primary visual cortex (r = -0.275, p = 0.005) and secondary visual cortex (r = -0.226, p = 0.025) exhibited an inverse association with RLS symptom severity. The prefrontal cortex, primary somatosensory cortex, and visual cortex showed potential as diagnostic biomarkers for distinguishing RLS from primary insomnia. These findings indicate that QEEG-based functional connectivity analysis shows promise as a valuable diagnostic tool for RLS and provides insights into its underlying mechanisms. Further research is needed to explore this aspect further.

0702 Suicidality in Patients Using Opioid Medications to Treat Severe, Refractory Restless Legs Syndrome: Prevalence and Associations

Abstract Introduction Prior investigations demonstrate a high prevalence of suicidal ideation and behavior in Restless Legs Syndrome (RLS) patients, particularly those with depression and severe RLS symptoms. The present study examines the prevalence of, and associations with, active suicidal ideation (ASI) and passive suicidal ideation (PSI) in patients using prescribed opioids for severe refractory RLS. Methods The National RLS Opioid Registry is an observational longitudinal study consisting of individuals taking a prescribed opioid for diagnosed RLS, nearly all with previously augmented symptoms. Information on opioid dosages, side effects, past and current concomitant RLS treatments, RLS severity, psychiatric symptoms, and opioid abuse risk factors were collected at baseline and every 6 months thereafter by REDCap surveys. Two years following enrollment, the C-SSRS was utilized to assess both PSI and ASI in the previous year, whereas the last question on the PHQ-9 assessed PSI in the past two weeks. Results At baseline, participants reported a reduction in previous suicidality following initiation of opioids: ASI from 22.0% to 7.0%, and PSI from 36.7% to 13.4%. At the 2-year PHQ-9 survey, 10.1% of registry participants reported PSI within the two previous weeks. At that same 2-year assessment, on the C-SSRS, 7.8% of participants reported both PSI and ASI in the past year. Overall, suicidality was associated with depression, anxiety, female sex, and perceived opioid stigma. PSI was less likely to be present in those taking methadone. Serial mediation analysis found that both RLS severity and depression severity moderated the relationship between methadone use and PSI. Specifically, methadone use was associated with decreased RLS severity, which was associated with decreased depression severity, and then further, less PSI. Conclusion Maximal treatment of RLS symptoms and approaches which mitigate the other clinical features associated with ASI and PSI in this population (anxiety, depression, stigma) are worthy of independent therapeutic attention. Similarly, this data may be useful for prescribers when assessing the appropriateness of opioid treatment for individual patients. Support (if any) The National RLS Opioid Registry has received support from the RLS Foundation, the Baszucki Brain Research Fund, Florence Petrlik Family Foundation, Diane and Richard Brainerd, and the Blakeley Foundation.

The effects of restless legs syndrome on sleep and quality of life during pregnancy: a comparative descriptive study

Objective: The study aimed to identify the effects of restless legs syndrome (RLS) on sleep quality and quality of life in pregnant women.Methods: This comparative and descriptive study was conducted with 109 pregnant women between the 24 and 39 weeks of gestation. The presence and severity of RLS were investigated using the International Restless Legs Syndrome Study Group’s Diagnostic Criteria Scale and Severity Rating Scale, and the effects of the syndrome on sleep and quality of life were evaluated. Results: The prevalence of RLS in pregnant women was found to be 47.7%. In the RLS group, 22.0% of the pregnant women had severe RLS symptoms and 20.2% had moderate RLS symptoms. The mean score for Restless Legs Syndrome Severity Rating Scale was determined 20.75±6.38. The mean score for quality of life scale was determined 17.75±3.73 in RLS group and 26.46±2.67 in non-RLS group. Conclusion: The difference between the mean scores for Pittsburgh Sleep Quality Index of the pregnant women with RLS and those without the syndrome was found to be statistically significant. While the mean score for Quality of Life Scale in pregnant women with RLS was lower in general health, physical health and psychological health sub-dimensions, no statistically significant difference was found in social relations and environment sub-dimensions. It is recommended that nurses investigate RLS complaints of pregnant women and include non-pharmacological methods in their nursing practices.

Emergence of restless legs syndrome during opioid discontinuation.

The development of restless legs syndrome (RLS) has been rarely reported during and following opioid withdrawal. We aimed to determine the presence and severity of RLS symptoms during and after supervised opioid tapering. Ninety-seven adults enrolled in the Mayo Clinic Pain Rehabilitation Center who underwent supervised prescription opioid tapering were prospectively recruited. RLS presence and severity was assessed with the Cambridge-Hopkins Questionnaire 13 and International Restless Legs Syndrome Study Group Rating Severity Scale at admission, midpoint, and dismissal from the program as well as 2 weeks, 4 weeks, and 3 months after completion. Frequency and severity of RLS symptoms were compared between admission and each time point. Average age of the cohort was 52.6 ± 13.3 years with a morphine milligram equivalent dose for the cohort of 45.6 ± 48.3 mg. Frequency of RLS symptoms increased from 28% at admission to peak frequency of 41% at 2 weeks following discharge from the Mayo Pain Rehabilitation Clinic (P = .01), returning to near baseline frequency 3 months after opioid discontinuation. International Restless Legs Syndrome Study Group Rating Severity Scale increased from baseline and then remained relatively stable at each time point following admission. Thirty-five (36.1%) participants developed de novo symptoms of RLS during their opioid taper, with those being exposed to higher morphine milligram equivalent doses having higher risk of developing RLS. Moderately severe symptoms of RLS, as assessed by survey, occur commonly in individuals undergoing opioid tapering, particularly if exposed to higher doses. In many cases, symptoms appear to be self-limited, although a minority develop persistent symptoms. Our results may have implications for successful opioid tapering, but future confirmatory studies with structured clinician interview are needed to establish that these symptoms truly represent restless legs syndrome given the potential for RLS-mimicking symptoms in individuals with chronic pain syndromes. McCarter SJ, Labott JR, Mazumder MK, etal. Emergence of restless legs syndrome during opioid discontinuation. J Clin Sleep Med. 2023;19(4):741-748.

Initial Cervical Spinal Cord Demyelinating Lesions are not Associated with Restless Legs Syndrome in Patients with Multiple Sclerosis.

This study aims to determine the prevalence and severity of restless legs syndrome (RLS) in patients with multiple sclerosis (MS) and its association with spinal cord lesions, fatigue, quality of life, and sleep disturbance. We recruited 222 consecutive MS patients admitted to MS outpatient clinic. Beck's Depression Inventory (BDI), Fatigue Severity Scale (FSS), Epworth Sleepiness Scale (ESS), Pittsburgh Sleep Quality Index (PSQI), and MS Quality of Life-54 (MSQoL-54) questionnaire scores of all patients were measured. Initial cervical spinal cord magnetic resonance imaging (MRI) of the patients at first clinical evaluation for diagnosis was reviewed for accompanying demyelinating lesions. RLS was diagnosed in 53 (23.87%) patients. RLS was associated with poor sleep, worse quality of life, increased fatigue, and depressive mood. The sleep quality index, FSS, and MSQoL-54 physical composite scores significantly correlated with RLS severity (P < 0.001, P = 0.001, P < 0.001, respectively). Of the 200 patients, 127 (63.5%) had spinal cord lesions. 22.83% of the patients with cervical spinal cord lesions had RLS comorbidity. We found no significant difference regarding spinal cord demyelinating lesions between RLS positives and negatives. (P = 0.77). In addition, having multiple spinal cord demyelinating lesions did not differ between the two groups (P = 0.84). Besides, the severity of RLS symptoms did not differ in patients who had a single cervical spinal lesion and those who had multiple lesions (P = 0.35). We have demonstrated the negative impact of comorbid RLS on fatigue, sleep quality, mood, and quality of life in MS patients. However, initial spinal cord lesions did not correlate with RLS comorbidity. The severity of RLS symptoms is associated with poor sleep and physical health.

Cognitive strategies to improve symptoms of restless legs syndrome.

Symptoms of restless legs syndrome are relieved by movement. Whether a cognitive task decreases sensory discomfort remains understudied. We aimed to assess the frequency of patients with restless legs syndrome who report decreased sensory discomfort during cognitive activities, and quantify this decrease during a cognitive task. Three-hundred and fifty-eight consecutive adults with restless legs syndrome (age 55.17 ± 14.62 years; 55.87% women; 27.65% treated) answered the question: "Does the intensity of your restless legs syndrome symptoms decrease when you perform activities other than moving your legs?" rated on a nine-point Likert scale (from fully-agree to totally-disagree). A subgroup of 65 consecutive drug-free patients underwent an 80-min suggested immobilisation test at 20:00 hours to quantify legs discomfort on a visual analogue scale before polysomnography, including 40 patients performing a cognitive task (balloon analogue risk task) from the 60 to 80 min. A total of 130 (36.3%) patients reported a decrease, 158 (44.1%) no decrease, and 70 (19.5%) uncertain changes in severity of restless legs syndrome symptoms during cognitive activities, with a similar proportion whether treated or not. Patients experiencing a decrease had less severe restless legs syndrome symptoms. In the suggested immobilisation test, mixed-effect regression models showed that legs discomfort decreased in patients performing the cognitive task while it continued to increase in those without task, with a larger difference in patients reporting a self-reported decrease in restless legs syndrome during cognitive activities. In conclusion, one-third of patients reported a self-reported decrease of restless legs syndrome symptoms during cognitive activities, this improvement in restless legs syndrome was confirmed during a sustained cognitive task. Cognitive strategies could be implemented for the management of restless legs syndrome.

Effect of stretching exercises versus thermotherapy on restless legs syndrome symptoms, pain, and quality of sleep among pregnant women

Background: Restless legs syndrome (RLS) is a sensory-motor disorder affecting up to one in three pregnant women, which peaks during the third trimester and is linked to poor pregnancy outcomes. Symptoms typically worsen during a period of inactivity, especially at night, resulting in sleep disruption or deprivation. This study aimed to compare the effects of stretching exercises versus thermotherapy on RLS symptoms and sleep quality among pregnant women. Study design: A quasi-experimental study was carried out at the antenatal outpatient clinic of Maternity University Hospital. A sample of 60 pregnant women was randomly assigned to two groups. One group was instructed to perform leg stretching exercises daily for one week, and the other group applied thermotherapy. They rated their RLS symptoms, pain level, and sleep quality at baseline and after receiving interventions. Results: the severity of RLS symptoms declined to a mild level among pregnant women immediately and after one week of performing stretching exercises (53.3%, 93.3%), compared to 6.7% and 63.3% of those who applied thermotherapy (p=0.001, p= 0.02).

0558 Emergence of Restless Legs Syndrome During Opioid Withdrawal

Abstract Introduction Discontinuation of opioid medications may be associated with emergence of restless legs syndrome (RLS), which may complicate opioid withdrawal. However, this has not been systematically studied. We aimed to prospectively determine the frequency of the occurrence and severity of RLS symptoms in patients undergoing physician supervised opioid tapering during a 3-week interdisciplinary pain rehabilitation program. Methods Adult patients undergoing prescription opioid taper were prospectively recruited during their participation in the Mayo Pain Rehabilitation Center from 2016 to 2021. Subjects completed the Cambridge-Hopkins RLS Questionnaire 13 and International Restless Legs Syndrome Study Group Rating Scale (IRLS) at baseline, midpoint, and dismissal from the program as well as 2 weeks, 1 and 3 months after dismissal from the program. Results 101 patients participated with 61% being female taking a mean morphine equivalent dose of 46.6 ± 49.0 mg. Baseline prevalence of RLS symptoms was 29% (29/101), increasing to 32% (32/101) at midpoint of treatment and further to 35% (34/97) at dismissal from the program. Frequency of RLS symptoms peaked 2 weeks after dismissal at 38% (30/78) and steadily declined to 35% (28/80) and 31% (21/68) at 1 month and 3 months after dismissal, respectively. Thirty-five percent of patients without baseline RLS symptoms reported de novo RLS symptoms at some point during their opioid taper. RLS severity score followed a similar trend as the presence of symptoms with a baseline of 16.6 ± 10.0. RLS severity score was maximum at 19.1 ± 7.3 one month following dismissal and decreased but remained elevated above baseline at 3 months following dismissal. Conclusion Symptoms of RLS occurred in over a third of patients on chronic opioids and increased during opioid withdrawal, appearing to peak in frequency and severity 2-4 weeks after discontinuation and gradually improved 3 months after discontinuation. Over one-third of patients in our cohort developed de novo symptoms of RLS at some point during their opioid withdrawal. Physicians supervising individuals undergoing opioid withdrawal should be aware of the potential development of RLS symptoms which may hinder successful opioid withdrawal. Support (If Any)

Restless legs syndrome severity in the National RLS Opioid Registry during the COVID-19 pandemic

Objective/backgroundNo research has yet assessed the impact of the coronavirus disease 2019 (COVID-19) pandemic on restless legs syndrome (RLS). We hypothesized that RLS symptom severity would be increased during the COVID-19 pandemic in a sample of patients with diagnosed RLS. Patients/methodsThe National RLS Opioid Registry is a longitudinal observational study of patients using opioid medications for treatment of RLS. Questionnaires assessing RLS symptom severity, medication dosages, sleep disturbance, depression, and anxiety are administered at baseline and at recurring 6-month surveys. Survey responses from the outset of the pandemic in April/May 2020 were compared to responses completed by other participants in January/February 2020 (between-subjects analysis), as well as responses by the same participants at baseline, approximately six months later in September 2020 through February 2021, and approximately one year later in March through June 2021 (within-subjects analyses). ResultsThese analyses provide evidence for higher RLS symptom severity scores at the outset of the COVID-19 pandemic in the US. Symptom severity scores were still elevated on subsequent questionnaires completed over six months into the pandemic but had returned towards baseline by the spring of 2021. Participants with increases in RLS severity were significantly more likely than others to see increases in sleep disturbance, depression, and anxiety. ConclusionsThis is the first study demonstrating increased RLS symptom severity during the earliest stage of the COVID-19 pandemic. These findings warrant similar investigations in other patient populations and suggest that clinicians should attend to RLS symptoms during times of socioeconomic and/or political uncertainty.

Analysis of Serum Vitamin D Level and Related Factors in Patients With Restless Legs Syndrome.

Objective: This study aimed to detect serum vitamin D (VitD) levels in patients with primary restless legs syndrome (RLS). The further objective was to analyze the relationship of VitD levels with the severity of RLS symptoms, sleep, anxiety, and depression.Methods: The serum 25-hydroxyvitamin D [25(OH)D] levels of 57 patients with primary RLS and the healthy physical examinees in our hospital during the same period were detected. The International Restless Legs Syndrome Study Group (IRLSSG) rating scale for measuring RLS severity and Pittsburgh Sleep Quality Index (PSQI) Scale, 24-item Hamilton Depression Rating Scale (HAMD24), and 14-item Hamilton Anxiety Scale (HAMA14) were used to assess the severity of symptoms, sleep, and emotional state of patients with RLS. Based on VitD level and IRLSSG score, they were grouped for analysis.Results: The serum 25(OH)D level was significantly lower in patients with RLS than in healthy controls, and the incidence of insufficient serum VitD levels was significantly higher in patients with RLS than in healthy people (both P < 0.05). The serum VitD level was significantly lower in (extremely) severe patients with RLS than in mild to moderate patients with RLS (P < 0.05). The IRLSSG scale score and HAMD24 score were significantly higher in patients with RLS with insufficient serum VitD levels than those with normal serum VitD levels (both P < 0.05). Correlation analysis of IRLSSG scale score with serum VitD level and each scale score in patients with RLS showed that IRLSSG scale score was negatively correlated with VitD level, but positively correlated with PSQI, HAMA14, and HAMD24 scores. The results of correlation analysis between serum VitD levels and each scale score in patients with RLS indicated that serum VitD levels were negatively correlated with IRLSSG scale scores, PSQI scores, and HAMD24 scores.Conclusion: The serum VitD level is generally lower in patients with RLS than in healthy people, and lower serum VitD level is associated with more severe symptoms of RLS, worse quality of sleep, and worse depression.

Effective and Safety Analysis of Electroacupuncture Treatment for Restless Legs Syndrome in Maintenance Hemodialysis Patients

BACKGROUND: Restless legs syndrome (RLS) is a common complication in maintenance hemodialysis (MHD) patients. Current study was conducted to analysis the effectiveness and safety of electroacupuncture on 3 acupuncture points from lower limb meridians in the treatment of RLS.&lt;br/&gt; METHODS: A total of 7 MHD patients (5 Male and 2 Female) in our center with severe RLS symptom were enrolled. After one month of pharmacological washout period, patients received 12 sessions of electroacupuncture on three acupoints (Zusanli (ST36), Sanyinjiao (SP6) and Taichong (LR-3)) during HD. Severity of RLS symptoms and the sleep quality were evaluated by IRLSSG and ISI scores for 3 times (before, after and 1 month later of the electroacupuncture treatment).&lt;br/&gt; RESULTS: The average age of enrolled patients was 52.6±8.9 years, with median dialysis duration of 3.0 years. The hemoglobin level was 125.9±22.9 g/l. The IRLSSG score was significantly lower after electroacupuncture treatment (9.4±3.9) than that before treatment (17.3±4.7) (P &lt;0.01). Both overall severity of RLS symptom average daily severity and frequency were significantly improved after electroacupuncture. It is also validated that the electroacupuncture treatment was contributed to sleep improvement in RLS patients after electroacupuncture treatment was discontinued for one month.&lt;br/&gt; CONCLUSION: Electroacupuncture on three lower limbs acupoints during MHD was as a safe and effective treatment for attenuating the symptoms of RLS and improvement of sleep quality in hemodialysis patients, and the therapeutic effect maintain for at least one month.

The prevalence and clinical characteristics of restless legs syndrome in patients with iron deficiency anemia in Korea.

While the prevalence and clinical characteristics of restless legs syndrome (RLS) are known to vary according to ethnicity, a detailed evaluation of this condition among patients with iron deficiency anemia (IDA) has not yet been reported in an Asian population. We investigated the prevalence and clinical characteristics of RLS in patients with IDA in Korea compared with age- and sex-matched patients diagnosed with idiopathic RLS. This prospective single-center study was performed at a regional university hospital. Consecutive patients with IDA were enrolled over a 4-year period. Clinical interviews and laboratory tests were conducted at the first visit. RLS diagnosis was confirmed through face-to-face interviews. We randomly selected patients with idiopathic RLS without comorbid medical disorders from our sleep center dataset as control patients. The clinical characteristics of both groups were compared. We enrolled 124 patients with IDA. Fifty (40.3%) patients were diagnosed with RLS, with 82% exhibiting severe to very severe symptoms. Patients with IDA and RLS were older and reported more sleep deterioration than patients with IDA without RLS. Patients with IDA and RLS also had a more depressed mood and higher periodic limb movement index scores than patients with idiopathic RLS. The prevalence of RLS among patients with IDA in Korea was high, with the majority having severe to very severe symptoms. Patients with IDA and RLS had poorer sleep quality and more emotional problems than patients with IDA without RLS. Therefore, patients with IDA should be screened for RLS to prevent adverse effects on the quality of sleep and life.

Restless Legs Syndrome: Contemporary Diagnosis and Treatment.

Restless legs syndrome (RLS) is characterized by an uncomfortable urge to move the legs while at rest, relief upon movement or getting up to walk, and worsened symptom severity at night. RLS may be primary (idiopathic) or secondary to pregnancy or a variety of systemic disorders, especially iron deficiency, and chronic renal insufficiency. Genetic predisposition with a family history is common. The pathogenesis of RLS remains unclear but is likely to involve central nervous system dopaminergic dysfunction, as well as other, undefined contributing mechanisms. Evaluation begins with a thorough history and examination, and iron measures, including ferritin and transferrin saturation, should be checked at presentation and with worsened symptoms, especially when augmentation develops. Augmentation is characterized by more intense symptom severity, earlier symptom occurrence, and often, symptom spread from the legs to the arms or other body regions. Some people with RLS have adequate symptom control with non-pharmacological measures such as massage or temperate baths. First-line management options include iron-replacement therapy in those with evidence for reduced body-iron stores or, alternatively, with prescribed gabapentin or pregabalin, and dopamine agonists such as pramipexole, ropinirole, and rotigotine. Second-line therapies include intravenous iron infusion in those who are intolerant of oral iron and/or those having augmentation with intense, severe RLS symptoms, and opioids including tramadol, oxycodone, and methadone. RLS significantly impacts patients' quality of life and remains a therapeutic area sorely in need of innovation and a further pipeline of new, biologically informed therapies.

Restless legs syndrome/Willis-Ekbom disease in multiple sclerosis: a contributing factor for anxiety, disability, sleep disorder, and quality of life.

Restless legs syndrome (RLS) is one of the most common and burdensome sleep disorders in the course of multiple sclerosis (MS). To evaluate common MS-related symptoms and consequences between groups with and without RLS and further assess the association of quality of life determinants with RLS symptom severity. According to their RLS status, 46 relapsing-remitting MS patients were divided into MS-RLS+ (n=19) and MS-RLS- groups (n=27). Specific questionnaires were administered to assess the patients' health-related quality of life (HRQoL), fatigue levels, sleep quality, daily sleepiness, anxiety, and depression symptoms. Functional capacity was examined using the Expanded Disability Status Scale (EDSS). The prevalence of RLS was 41.3%. Compared to the MS-RLS- group, those with RLS had higher EDSS scores, more cranial and spinal lesions, longer disease duration, and were older. In the MS-RLS+ group, symptom severity scores were positively correlated with higher anxiety and poorer sleep quality. The symptom severity score was negatively correlated with mental HRQoL and pain scores. In conclusion, the findings of the current study indicate the negative impact of RLS on functional capacity, anxiety, sleep quality, and mental HRQoL of MS patients. Further studies using more accurate diagnostic strategies for identifying RLS and other sleep disorders are necessary to clarify the association of MS with RLS and explore relevant clinical implications.

Low risk of iron overload or anaphylaxis during treatment of restless legs syndrome with intravenous iron: a consecutive case series in a regular clinical setting

ObjectiveTo evaluate the incidence of iron overload and anaphylaxis following intravenous (IV) iron treatment of restless legs syndrome (RLS). MethodsA total of 58 consecutive RLS patients, meeting clinical requirements for IV iron treatment according to current IRLSSG guidelines were recruited. IV iron treatment consisted of two 500 mg infusions of ferric carboxymaltose (FCM) administered five days apart. During each of the three follow-up visits we obtained blood samples, substantia nigra echogenity index (SNEI) by means of transcranial sonography (TCS), and assessed the severity of RLS symptoms (IRLS scale). “Iron overload risk” was defined as transferrin saturation (TSAT) > 45% on two consecutive follow-up visits. In patients who had a reduction in systemic iron levels following treatment, an additional 500 mg of FCM was administered when feasible. In such cases an additional two follow-up visits were performed. ResultsAmong the total sample, only 2/58 participants met criteria for iron overload risk. They had no evidence of liver damage and did not require additional treatment. Among the 21 patients receiving an additional 500 mg infusion after, only one patient was diagnosed with iron overload risk. Among these three patients, only one was a hemochromatosis gene carrier. No anaphylaxis or other side-effects were reported. ConclusionsIn real-life clinical conditions, the risk of iron overload is low when IV FCM is administered according to the safety limits defined in the current RLS treatment guidelines. However, a close clinical follow-up with periodic blood sampling for iron status, is needed.

0809 A Randomized Double-blind, Placebo Controlled Trial With Cross-over, To Assess The Efficacy Of Correcting Vitamin D Deficiency In Improving The Symptoms Of Restless Legs Syndrome (RLS)

Abstract Introduction Recent studies have shown an association of low Vitamin D levels and severity of RLS symptoms. However, effect of treatment of Vit D deficiency on RLS symptoms was not reported, nor were other exacerbating factors for RLS such as iron deficiency or OSA addressed in prior studies, but have been addressed in our study. Methods This is an ongoing study at the JFKMC Sleep Clinic. Eligible Patients with RLS include those with vitamin D 25,hydroxy deficiency (&amp;lt;20 ng/ml), or insufficiency (&amp;lt;30 ng/ml). Such patients will be enrolled in the study after comorbid conditions like iron deficiency and OSA have been adequately corrected. Randomization of the patients will be done by the JFK pharmacy so the patient and provider are blinded to the substance. Substance A or B could be either Vitamin D3 Capsule 50,000 IU, or placebo. Each patient takes A for 6 weeks and then crosses over to B for 6 weeks. Weekly iRLS questionnaires will be collected. Actiwatch Device, to assess activity count per minute, will be worn on the ankle at night for one week time periods: at baseline, at end of 6 weeks of taking A and then at the end of 6 weeks of taking B. Vitamin D levels will also be assessed after each course of supplementation and correlated with subjective and objective findings. Results Between July 7, 2019 to current, 50 consecutive patients seen in sleep clinic with RLS were assessed for vitamin D levels. Ages ranged from 23-86 years. 27 patients were female (54%). Two patients met inclusion criteria and have started their 13-week study. Conclusion This study will help to establish the role of Vitamin D deficiency as a risk factor for RLS, independent of ferritin levels, and comorbid OSA, in affected individuals. This may help to discover a potentially treatable form of RLS. Support No financial support.

Impact of Positive Airway Pressure on International Restless Legs Syndrome Score in Sleep Disordered Breathing.

Study Objective: Studies have shown increased prevalence of restless legs syndrome (RLS) in sleep disordered breathing (SDB), however limited data have focused on the impact of SDB therapy on RLS. We hypothesize that positive airway pressure (PAP) will improve the International Restless Legs Syndrome (IRLS) score among SDB patients compared to patients without PAP. Methods: Patients with AHI ≥ 5 who responded positively to a RLS qualifier question from January 2010 to May 2015 were included in this retrospective study. IRLS score was used to measure RLS symptom severity. Two-sample t-tests and one-way analysis of variance were used to compare changes in IRLS score and linear regression models were created to examine IRLS change with PAP use and PAP adherence (PAP usage ≥4 h nightly for ≥70% of nights), adjusting for potential confounders. Results: In 434 patients (51.9 ± 13.4years, 50.5% female, 77.6% Caucasian; 325 PAP, 109 control), IRLS scores improved from baseline to follow-up, with the PAP group achieving significant improvement after adjustment for covariates (difference in IRLS: −1.8 (CI −3.6,0.00), p = 0.050). In self-reported PAP adherent patients, IRLS improvement was greater than controls (−5.3 ± 7.4 vs. −2.7 ± 7.6 respectively, p = 0.045), and comparable to non-adherent patients (−5.3 ± 7.4 vs. −3.0 ± 7.0, p = 0.091). Conclusions: Among SDB patients with a positive RLS qualifier, those who used PAP therapy achieved significantly greater improvement in IRLS scores than patients who did not use PAP, with more significant changes in the PAP adherent group. This is the first large clinical study to examine these relationships, providing a basis for future prospective interventional trials and informing clinicians of expected improvement in IRLS score in PAP treated SDB populations.

Acceptability and feasibility of a 12-week yoga vs. educational film program for the management of restless legs syndrome (RLS): study protocol for a randomized controlled trial

BackgroundRestless legs syndrome (RLS) is a common and burdensome sleep disorder associated with profound impairment of health, well-being, and quality of life. Unfortunately, the medications used for RLS management carry risk of serious side effects, including augmentation of symptoms. Yoga, an ancient mind-body discipline designed to promote physical, emotional, and mental well-being, may offer a viable, low-risk new treatment. The primary objectives of this pilot, parallel-arm, randomized controlled trial (RCT) are to assess the acceptability and feasibility of a 12-week yoga vs. educational film program for the management of RLS.MethodsForty-four adults with confirmed moderate to severe RLS will be recruited and randomized to a 12-week yoga (n = 22) or standardized educational film program (N = 22). Yoga group participants will attend two 75-min Iyengar yoga classes per week for the first 4 weeks, then one 75-min class per week for the remaining 8 weeks, and will complete a 30-min homework routine on non-class days. Educational film group participants will attend one 75-min class per week for 12 weeks and complete a daily RLS treatment log; classes will include information on: RLS management, including sleep hygiene practices; other sleep disorders; and complementary therapies likely to be of interest to those participating in a yoga and sleep education study.Yoga and treatment logs will be collected weekly. Feasibility outcomes will include recruitment, enrollment, and randomization rates, retention, adherence, and program satisfaction. Program evaluation and yoga-dosing questionnaires will be collected at week 12; data on exploratory outcomes (e.g., RLS symptom severity (IRLS), sleep quality (PSQI), mood (POMS, PSS), and health-related quality of life (SF-36)) will be gathered at baseline and week 12.DiscussionThis study will lay the essential groundwork for a planned larger RCT to determine the efficacy of a yoga program for reducing symptoms and associated burden of RLS. If the findings of the current trial and the subsequent larger RCTs are positive, this study will also help support a new approach to clinical treatment of this challenging disorder, help foster improved understanding of RLS etiology, and ultimately contribute to reducing the individual, societal, and economic burden associated with this condition.Trial registrationClinicalTrials.gov, ID: NCT03570515. Retrospectively registered on 1 February 2017.

Efficacy of vitamin D replacement therapy in restless legs syndrome: a randomized control trial

Restless legs syndrome is a movement sleep disorder that may be linked to dopaminergic dysfunction and in which vitamin D may play a role. This 12-week randomized, placebo-controlled trial elucidated the efficacy of vitamin D supplements in decreasing restless legs syndrome symptom severity. Thirty-five subjects with restless legs syndrome, diagnosed using the International Restless Legs Syndrome Study Group criteria, were enrolled. The subjects were randomized to orally receive either vitamin D (50,000IU caplets) or a placebo. All medications were administered weekly using a direct observation technique. Clinical assessments, including those for restless legs syndrome severity, were conducted at baseline and the end of the study using the International Restless Legs Syndrome Study Group rating scale. The serum vitamin D levels and bone profiles were measured at baseline and every 4weeks. The primary endpoint was the change in the restless legs syndrome severity score from baseline to week 12. There were 17 and 18 patients in the vitamin D and placebo groups, respectively. The groups did not differ with respect to age, sex, restless legs syndrome severity, or vitamin D levels. Participants in the vitamin D group showed no significant change in the mean restless legs syndrome severity score compared with the placebo group. The results suggest that vitamin D supplementation does not improve restless legs syndrome symptoms. ClinicalTrials.gov : NCT02256215 (available from: https://clinicaltrials.gov/ct2/show/NCT02256215 ).