NCT06866132进行中（未招募）不适用
Form, Fit and Function Feasibility Study
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 20
- 试验地点
- 2
- 主要终点
- Mean Change in IRLS Rating Scale Score
研究概览
简要总结
This study assesses the tolerability, safety, and impact of an investigational medical device on restless legs syndrome symptoms.
The IRB has established that the investigational device is non-significant risk.
详细描述
In this 12-week study, participants complete a 2-week baseline (no intervention) followed by 8-weeks of investigational medical device intervention (weeks 3-10) followed by 2-weeks with no intervention (weeks 11-12).
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
- 21 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Subject has signed a valid, IRB-approved informed consent form, can understand the requirements of the study and instructions for device usage, and can converse in English
- •Subject has received a medical diagnosis of primary restless legs syndrome.
- •Subject agrees to not change dosage or schedule of any medications that are known to impact RLS symptoms during the study, including RLS medications, antidepressants, sleep medications, or sedative antihistamines.
- •Subject has moderate-severe RLS symptoms as defined by a score of 15 or greater points on IRLS (International Restless Legs Syndrome Study Group Rating Scale) over the week prior to study entry.
- •Subject reports that RLS symptoms caused awakenings or interfered with falling back asleep at least 3 nights per week during the month prior to study entry,
- •Subject reports that RLS symptoms are most significant in lower legs and/or feet.
排除标准
- •The subject has an active medical device implant anywhere in the body (including but not limited to pacemakers, spinal cord stimulators, deep brain stimulators).
- •The subject has a metal implant at the site of the study device electrode application (not including knee replacements).
- •The subject has been diagnosed with epilepsy or other seizure disorder.
- •The subject has a moderate or severe cognitive disorder or mental illness that would affect his or her ability to participate in the study.
- •The subject has a known allergy to device materials, electrode gel, polyurethane foam, or lycra (or a severe previous reaction to medical adhesives or bandages).
- •Subject has any of the following at or near the location of device application: Acute injury, Cellulitis, Open sores
- •The subject is unable or unwilling to comply with study requirements.
- •The subject has a medical condition not listed above that may put them at risk.
- •Subject has prior experience with any neurostimulation devices developed by the study sponsor
- •Subject has a primary sleep disorder other than RLS that significantly interferes with sleep at the present time (e.g. obstructive sleep apnea stably controlled via CPAP would not be an exclusion).
- •On nights with no RLS symptoms (if any), subject reports typical sleep onset latency of >60min.
- •Subject has severe peripheral neuropathy affecting the lower legs and/or subject has neuropathy and is unable to clearly distinguish between symptoms of neuropathy and symptoms of RLS.
- •Subject reports that bedtime is typically outside of 9pm-3am or reports that bedtime regularly varies by more than 4 hours, such as due to shift work.
- •During initial device set-up, device does not properly fit the subject or calibrated intensity settings are outside of operational range
结局指标
主要结局
Mean Change in IRLS Rating Scale Score
时间窗: 10 weeks
International Restless Legs Syndrome Study Group (IRLS) Rating Scale Score is a participant-rated questionnaire that rates RLS severity from 0-40, where 40 is the most severe. The mean change is assessed from study entry to Week 10.
次要结局
- Mean change in the number of nights with RLS per week(10 weeks)
- Mean Change in MOS-II(10 weeks)
- Mean Change in MOS-I(10 weeks)
- Mean PGI-I score(10 weeks)
- Percent of Patients Reporting Much Improved or Very Much Improved(10 weeks)
- Mean Change in Periodic Limb Movement Index (PLMI)(10 weeks)
- Mean Change in Sleep Efficiency Percentage(10 weeks)
- Mean Change in Minutes Awake after Sleep Onset (WASO)(10 weeks)
- Mean Change in Total Sleep Time (TST)(10 weeks)
研究者
研究点 (2)
Loading locations...
相似试验
已完成
不适用
Wearability, Saefty and Usability Assessment for the Upper Limb Exoskeleton BRIDGE/EMPATIAMuscular DystrophiesNCT03951844Alessandra Pedrocchi14
进行中（未招募）
不适用
Multi-sensory Intervention Room Application (MIRA) Device in the NSICUPost Intensive Care SyndromeNCT06509815Icahn School of Medicine at Mount Sinai34
进行中（未招募）
不适用
Cook Venous Valve System for Treatment of Chronic Venous InsufficiencyVenous Insufficiency of LegNCT05883943MED Institute Inc.4
已完成
不适用
A Prospective Study Of Free-Hand Transperineal Image Fusion Targeted Biopsies Under Local AnesthesiaProstate NeoplasmNCT04376008The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School1,050
已完成
不适用
A Feasibility Study to Evaluate the Safety and Effectiveness of Implantation of Flowise Cerebral Flow Diverter (Flowise)Intracranial AneurysmNCT02609867Yonsei University10