NCT03852771终止不适用
CompRESsion Therapy for Restless Leg Syndrome: An Evaluation of Cirvo™ for the Treatment of Restless Leg Syndrome
Radial Medical, Inc.2 个研究点 分布在 1 个国家目标入组 18 人开始时间: 2019年3月12日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 发起方
- 入组人数
- 18
- 试验地点
- 2
- 主要终点
- Change in disease severity between the Baseline study visit and the 56-day visit, as assessed by the International Restless Leg Syndrome Study Group Severity Scale (IRLSS).
研究概览
简要总结
This study in patients with restless leg syndrome (RLS) will evaluate the use of Cirvo™ therapy for the treatment of this disorder when applied to both legs.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male or female over the age of
- •Diagnosis of Restless Leg Syndrome (RLS) per the Hopkins-Hening Diagnostic Questionnaire
- •International RLS Study Group (IRLSS) Score ≥
- •RLS symptoms occurring on at least 5 nights each week, with symptoms stable for at least 3 months.
排除标准
- •Known or suspected deep vein thrombosis.
- •Prior use with home intermittent pneumatic compression (IPC) device
- •Currently using any other device to treat RLS
- •Active skin infections in the affected leg
- •Vein ligation or skin graft of the leg within past 12 months
- •Mental or physical limitations that would prevent the subject from reliably completing study questionnaires.
- •Physical impairments that would prevent the use of the CirvoTM device.
- •Use of any medications typically used to treat RLS, where dose has not been stable for at least 2 months.
- •If previously on medication to treat RLS, patient must have been weened under medical supervision and off medication for at least 14 days at time of enrollment
- •History of pulmonary vascular disease (PVD)
- •History of pulmonary edema
- •History of decompensated congestive heart failure (CHF)
- •Open surgery or major trauma to the legs within the last six months
- •History of lower limb malignancy, primary or secondary
- •Acute symptomatic lower extremity thrombophlebitis
- •Any chronic back pain or lower extremity pain
- •Other sleep problems that are felt to be currently affecting the quality of sleep
- •Calf geometry on which Cirvo™ device does not appropriately fit
- •Known sensitivity to any of the materials used in the Cirvo™ device
- •Currently participating or plans to participate in in any other investigational clinical evaluation during the 56 day study period that may, in the opinion of the investigator, affect RLS.
结局指标
主要结局
Change in disease severity between the Baseline study visit and the 56-day visit, as assessed by the International Restless Leg Syndrome Study Group Severity Scale (IRLSS).
时间窗: 56 days
Assessment of change in IRLSS scores from Baseline study visit to 56 days.
次要结局
- Change in disease severity between the Baseline study visit and the 56-day visit, as assessed by the Clinical Global Impression (CGI-I) rating scale.(56 days)
- Change in sleep quality between the Baseline study visit and the 56-day visit, as assessed by the Medical Outcomes Study (MOS) sleep scale.(56 days)
- Change in disease severity between the Baseline study visit and after the last usage of the each parameter set trialed in Period 1 (nominally days 7, 14, 21, and 28), as assessed by the IRLSS.(28 days)
研究者
研究点 (2)
Loading locations...
相似试验
撤回
不适用
Vasculaire Leg Compression Device for the Treatment of Restless Legs Syndrome - A Prospective Clinical StudyEkbom SyndromeRestless Legs Syndrome,Restless Legs,NCT01861652Walter Reed National Military Medical Center
已完成
不适用
Hemodialysis Patients With Restless Legs Syndrome Used VibrationRLSNCT05249907Baskent University60
已完成
2 期
Restless Legs Syndrome Treatment With Botulinum ToxinRestless Legs SyndromeNCT00949806University Hospital, Bordeaux27
已完成
不适用
The Effect of Progressive Muscle Relaxation Exercise Training Given to Pregnant Women With Restless Leg SyndromeRestless Legs SyndromeNCT04853771Gazi University52
已完成
1 期
Treatment of Restless Leg Syndrome (RLS) Augmentation With Ecopipam, a D1 Specific AntagonistRestless Legs SyndromeAugmentationNCT03218969William Ondo, MD10