Sleep medicine
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Randomized Controlled Trial Multicenter Study
Efficacy and safety of zolpidem-MR: a double-blind, placebo-controlled study in adults with primary insomnia.
To evaluate the clinical efficacy and safety of modified-release zolpidem (zolpidem-MR 12.5mg) for the treatment of primary insomnia in adults. ⋯ Zolpidem-MR 12.5mg is effective and safe in treating primary insomnia in adults and improves sleep maintenance, induction and duration of sleep.
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Multicenter Study Comparative Study
The Johns Hopkins telephone diagnostic interview for the restless legs syndrome: preliminary investigation for validation in a multi-center patient and control population.
To develop and validate a telephone diagnostic interview (the Johns Hopkins telephone diagnostic interview for restless legs, abbreviated TDI) for diagnosis of the restless legs syndrome (RLS). ⋯ The TDI is a sensitive, specific, and reliable instrument for diagnosing RLS by experienced interviewers in a brief, anonymous telephone encounter.
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Multicenter Study
Validation of the International Restless Legs Syndrome Study Group rating scale for restless legs syndrome.
There is a need for an easily administered instrument which can be applied to all patients with restless legs syndrome (RLS) to measure disease severity for clinical assessment, research, or therapeutic trials. The pathophysiology of RLS is not clear and no objective measure so far devised can apply to all patients or accurately reflect severity. Moreover, RLS is primarily a subjective disorder. Therefore, a subjective scale is at present the optimal instrument to meet this need. ⋯ This scale meets performance criteria for a brief, patient completed instrument that can be used to assess RLS severity for purposes of clinical assessment, research, or therapeutic trials. It supports a finding that RLS is a relatively uniform disorder in which the severity of the basic symptoms is strongly related to their impact on the patient's life. In future studies, the IRLS should be tested against objective measures of RLS severity and its sensitivity should be studied as RLS severity is systematically manipulated by therapeutic interventions.