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Magnesium-L-Threonate for Sleep After Joint Replacement

This study is looking at whether Magnesium-L-Threonate (MgT) can improve sleep quality and reduce pain after total knee or hip replacement surgery. You might be able to join if you are at least 18 years old, speak English or Spanish, and are having a total knee or hip replacement at the University of Miami Hospital. People with a history of certain sleep disorders like narcolepsy or sleep apnea cannot participate. The study will measure changes in your sleepiness (using the Epworth Sleepiness Score) and overall sleep quality (using the Pittsburgh Sleep Quality Index) over 6 weeks to see if MgT is helpful. The current recruitment status is unclear, but the study plans to enroll 64 participants.

Study design
This interventional study plans to enroll 64 participants. Some participants will receive Magnesium Threonate, while others will receive sugar pills.
What's involved
Participants will take a pill daily for at least 6 weeks. Sleepiness and sleep quality will be measured at 2, 4, and 6 weeks.
Compensation
Not stated in the trial record.
Follow-up
Participants will be followed for at least 6 weeks after starting the intervention.

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NCT06902285

Magnesium-L-Threonate for Sleep Quality Post-Arthroplasty

Recruiting
PHASE4Ages 18+InterventionalSupportive care
University of Miami
~64 participants
Updated 2026-07-09 on ClinicalTrials.gov
What's tested:Magnesium ThreonateControl

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Change in Epsworth Sleepiness Score
Measured over 2 weeks, 4 weeks, 6 weeks
+1 more outcome measured

Conditions

Sleep
Knee Osteoarthritis

Explore related trials

Osteoarthritis

Where it's being run

1 sites across 1 states
Florida1

Study leadership

  • Victor H Hernandez, MD · PRINCIPAL_INVESTIGATOR · University of Miami

Who to contact

Victor H Hernandez, MD
[email protected]
305-689-5195
Email the study team

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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

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

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

What this trial measures

  • Change in Epsworth Sleepiness Score2 weeks, 4 weeks, 6 weeks

    Score ranging from 0-24 with higher scores indicating greater sleepiness.

  • Change in Pittsburgh Sleep Quality Index (PSQI)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