Use of Magnesium-L-Threonate to Improve Subjective Sleep Quality After Total Joint Arthroplasties: Randomized Controlled Clinical Trial
试验速览
- 阶段
- 4 期
- 状态
- 招募中
- 入组人数
- 64
- 试验地点
- 2
- 主要终点
- Change in Epsworth Sleepiness Score
研究概览
简要总结
The study team is conducting a study to see if Magnesium-L-Threonate (MgT) can help improve how well participants sleep and reduce pain after total joint replacement surgery
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- Double (Participant, Investigator)
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
- •Patients undergoing primary total knee or hip arthroplasty at the University of Miami Hospital
- •Patients > 18 years of age
- •Subjects must be capable of providing informed consent
- •English or Spanish-speaking
排除标准
- •Previous total joint arthroplasty at the surgical site
- •History of sleeping disorders, including narcolepsy, sleep apnea, insomnia, parasomnias, and restless leg syndrome.
- •History of Complex Regional Pain Syndrome in ipsilateral extremity
- •History of demyelinating disorder or neurologic deficit in the affected extremity
- •History of psychiatric disorders that could impact sleep, such as untreated depression, bipolar disorder, or schizophrenia.
- •Participants taking medications known to cause significant sedation or insomnia.
- •Pregnant or breastfeeding
- •Being treated for a diagnosis other than primary osteoarthritis (e.g. pelvic/femur fracture)
- •Patients with known substance use disorder within 6 months of surgery
- •Liver Failure, via clinical diagnosis or international normalized ratio greater than 1.5 or Prothrombin time greater than 40
- •Chronic Kidney Disease or glomerular filtration rate less than 30 mL/min
研究组 & 干预措施
Magnesium L Threonate Group
Participants in this group will receive the Magnesium L Threonate intervention for up to 6 weeks postoperatively
干预措施: Magnesium Threonate (Drug)
Control Group
Participants in this group will receive the placebo comparator for up to 6 weeks postoperatively
干预措施: Control (Other)
结局指标
主要结局
Change in Epsworth Sleepiness Score
时间窗: 2 weeks, 4 weeks, 6 weeks
Score ranging from 0-24 with higher scores indicating greater sleepiness.
Change in Pittsburgh Sleep Quality Index (PSQI)
时间窗: 2 weeks, 4 weeks, 6 weeks
The total score has a value between 0-21 and a high total score demonstrates a poor quality of sleep. A total PSQI score which is ≤5 indicates "good sleep", and a score which is \>5 indicates "poor sleep
次要结局
- Change in Morphine Milligram Equivalent Prescribed(2 weeks, 4 weeks, 6 weeks)
- Patient-reported outcome measured by Knee Injury and Osteoarthritis Outcome Score(6 weeks)
- Medication Compliance measured in number of days study medication taken(6 weeks)
研究者
Victor Hugo Hernandez
Professor
University of Miami