Publications by authors named "Jerrold Kram"

Article Synopsis
  • - The study aimed to assess the effectiveness and safety of tonic motor activation (TOMAC) in patients suffering from restless legs syndrome (RLS) that does not respond to medications.
  • - Conducted as a large, randomized, double-blind trial, it involved 133 participants and found that TOMAC significantly improved symptoms compared to a sham treatment, with a 45% responder rate in the active group at the end of the first stage.
  • - Results indicated that TOMAC was safe with mostly mild side effects, and it showed promise as an effective new treatment option for patients with medication-refractory RLS.
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Study Objectives: To evaluate long-term efficacy and safety of tonic motor activation (TOMAC) for treatment of medication-refractory moderate-to-severe primary restless legs syndrome (RLS).

Methods: In the parent study (RESTFUL), adults with refractory RLS were randomized to active TOMAC or sham for 4 weeks followed by 4 weeks of open-label active TOMAC. In the extension study, earlier RESTFUL completers comprised the control group (n = 59), which was followed for 24 weeks with no TOMAC intervention, and later RESTFUL completers compromised the treatment group (n = 44), which received 24 additional weeks of open-label active TOMAC followed by no intervention for 8 weeks.

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Study Objectives: To assess variable negative external pressure (vNEP) therapy using a range of pressures and varying collar sizes and shapes to identify combinations that improve the efficacy and comfort of this emerging therapy for obstructive sleep apnea (OSA).

Methods: This prospective, open-label pilot study included 28 eligible patients (71% men) having documented moderate OSA (apnea-hypopnea index [AHI] 15 events/h ≤ AHI ≤ 30 events/h) at 1 sleep clinic for an overnight, in-lab sleep trial. Each participant tested at least 2 of 6 available vNEP devices during sleep periods ≥ 2 hours.

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Study Objectives: To determine if the application of continuous negative external pressure (cNEP) is effective and safe in individuals with obstructive sleep apnea (OSA) during an overnight in-laboratory sleep study.

Methods: A prospective, open-label pilot study in subjects with documented OSA recruited from the patient population at one sleep clinic. The intervention was application and titration of cNEP during overnight polysomnography.

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Study Objectives: Evaluate the efficacy of a novel device placed in the nares that imposes an expiratory resistance for the treatment of obstructive sleep apnea (OSA) and evaluate adherence to the device over a 30-day in-home trial period.

Design: One diagnostic and 3 treatment polysomnograms were administered in a Latin-square design to identify the optimal expiratory resistance to be used during the 30-day in-home trial. Subjects had repeat polysomnography with the prescribed device at the end of the 30-day trial.

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