NCT06902285 Magnesium-L-Threonate for Sleep Quality Post-Arthroplasty
| NCT ID | NCT06902285 |
| Status | Recruiting |
| Phase | Phase 4 |
| Sponsor | University of Miami |
| Condition | Sleep |
| Study Type | INTERVENTIONAL |
| Enrollment | 64 participants |
| Start Date | 2025-04-21 |
| Primary Completion | 2027-07-01 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 4 studies follow an already-approved treatment in real-world conditions to monitor long-term safety and effectiveness.
This trial targets 64 participants in total. It began in 2025-04-21 with a primary completion date of 2027-07-01.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
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
Eligibility Criteria
Inclusion Criteria: * 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 Exclusion Criteria: * 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
Contact & Investigator
Victor H Hernandez, MD
PRINCIPAL INVESTIGATOR
University of Miami
Frequently Asked Questions
Who can join the NCT06902285 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Sleep. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT06902285 trial and what does that mean for participants?
Phase 4 studies are conducted after a treatment has been approved. They monitor long-term safety and real-world effectiveness in a broader patient population.
Is NCT06902285 currently recruiting?
Yes, NCT06902285 is actively recruiting participants. Contact the research team at vhh1@miami.edu for enrollment information.
Where is the NCT06902285 trial being conducted?
This trial is being conducted at Miami, United States.
Who is sponsoring the NCT06902285 clinical trial?
NCT06902285 is sponsored by University of Miami. The principal investigator is Victor H Hernandez, MD at University of Miami. The trial plans to enroll 64 participants.