BridgeMD
New treatment option for Sleep
Official title Magnesium-L-Threonate for Sleep Quality Post-Arthroplasty
ClinicalTrials.gov ID: NCT06902285
What this study is testing
What is Magnesium Threonate?
Magnesium Threonate is an investigational medicine, given as an once-daily pill taken by mouth, being studied as a potential treatment for sleep.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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
- Phase 4: studies an already-approved treatment
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- Patients undergoing primary total knee or hip arthroplasty at the University of Miami Hospital
- Patients \> 18 years of age
- people must be capable of providing informed consent
- English or Spanish-speaking
You likely can't join if
- 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.
See the full eligibility criteria
- Patients undergoing primary total knee or hip arthroplasty at the University of Miami Hospital
- Patients \> 18 years of age
- people must be capable of providing informed consent
- English or Spanish-speaking
- 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
The study team makes the final eligibility decision.
Where it's taking place
- Miami, Florida, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Miami, Florida, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.