RESTLESS LEGS SYNDROME (RLS) AND NEUROPATHY

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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.'