RESTLESS LEGS SYNDROME (RLS) AND NEUROPATHY

这个子项目是许多研究子项目中的一个 由NIH/NCRR资助的中心赠款提供的资源。子项目和 研究者（PI）可能从另一个NIH来源获得了主要资金， 因此可以在其他CRISP条目中表示。所列机构为 研究中心，而研究中心不一定是研究者所在的机构。 在美国，周围神经病变影响超过2000万人，每年的治疗费用超过40 - 100亿美元。临床表现可包括疼痛、足部溃疡、截肢和生活质量（QOL）下降。尽管存在这些严重后果，但除了糖尿病患者的葡萄糖水平的强化治疗和疼痛的对症治疗外，尚不存在治疗神经病变或改善QOL的有效疗法。 周围神经病患者经常抱怨腿部不适，使他们无法入睡。这种抱怨是不宁腿综合征（RLS）的主要特征，RLS是一种常见的睡眠障碍。已发表的报告引用了神经病患者中RLS的不同频率，这可能是由于研究方法的差异。RLS的成功治疗改善了一般人群的生活质量。然而，RLS或其治疗对神经病患者生活质量的影响从未被研究过。 这项研究将是第一个前瞻性的，基于临床的评估神经病变的RLS的患病率，使用完善的诊断标准。此外，我们将评估治疗RLS对神经病患者生活质量的影响。如果研究假设得到证实，临床医生将被提醒神经病患者中容易治疗的睡眠障碍的高患病率，以及有意义的干预的新机会。 该项目的具体目标是： 主要目的：描述周围神经病变患者样本中RLS的频率。 目标1：使用访谈和经验证的问卷来评估经病史、检查和电诊断研究证实的周围神经病变患者的RLS。 假设1：该样本中RLS的频率将超过10%。 探索性目的：评估RLS及其治疗对周围神经病患者生活质量的影响。 目的2A：在入组时，对所有患者进行Norfolk-神经病QOL问卷调查，对确定为RLS的患者进行RLS QOL问卷调查 假设2A：即使在校正神经病变的严重程度后，RLS神经病变患者的基线平均QOL评分也低于无RLS的神经病变患者。 目标2B：在治疗任何潜在神经病变或RLS后3个月时重新使用QOL工具。 假设2B：治疗3个月后，RLS神经病变患者的平均QOL评分将较基线改善 假设2C：有RLS的神经病变患者中QOL评分较基线的平均变化将超过无RLS的神经病变患者中QOL评分较基线的平均变化。'

This subproject is one of many research subprojects utilizing the resources provided by a Center grant funded by NIH/NCRR. The subproject and investigator (PI) may have received primary funding from another NIH source, and thus could be represented in other CRISP entries. The institution listed is for the Center, which is not necessarily the institution for the investigator. Peripheral neuropathy affects over 20 million people in the United States, with an annual treatment cost of over 4-10 billion dollars. Clinical manifestations can include pain, foot ulceration, limb amputation, and decreased quality of life (QOL). Despite these serious consequences, no effective therapy exists to treat neuropathy or improve QOL, other than intensive treatment of glucose levels in diabetic patients and symptomatic treatment of pain. A frequent complaint among patients with peripheral neuropathy is leg discomfort that prevents them from falling asleep. This complaint is the cardinal feature of restless legs syndrome (RLS), a common sleep disorder. Published reports cite different frequencies for RLS among neuropathy patients, perhaps due to differences in study methods. Successful treatment of RLS improves QOL in the general population. However, the impact of RLS, or its treatment, on QOL of neuropathy patients has never been studied. This study will be the first prospective, clinic-based assessment of the prevalence of RLS in neuropathy, using well-established diagnostic criteria. Furthermore, we shall assess the impact of treating RLS on the QOL in neuropathy patients. If study hypotheses are confirmed, clinicians will be alerted to the high prevalence of an easily treated sleep disorder in neuropathy patients, and to a new opportunity for meaningful intervention. The Specific Aims of this project are: Primary Aim: To characterize the frequency of RLS in a sample of patients with peripheral neuropathy. Aim 1: Use interviews and a validated questionnaire to assess for RLS in patients with peripheral neuropathy confirmed by history, exam and electrodiagnostic studies. Hypothesis 1: The frequency of RLS in this sample will exceed 10%. Exploratory Aim: To assess the impact of RLS and its treatment on QOL among peripheral neuropathy patients. Aim 2A: At enrollment, administer the Norfolk-neuropathy QOL questionnaire to all patients and the RLS QOL questionnaire to those identified with RLS Hypothesis 2A: Neuropathy patients with RLS will have lower mean QOL scores at baseline than neuropathy patients without RLS, even after adjustment for severity of neuropathy. Aim 2B: Re-administer the QOL instruments at 3 months, after treatment of any underlying neuropathy or RLS. Hypothesis 2B: The mean QOL score in neuropathy patients with RLS will improve from baseline after 3 months of treatment Hypothesis 2C: The mean change from baseline QOL score in neuropathy patients with RLS will exceed the mean change from baseline QOL score in neuropathy patients without RLS.'