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NCT06902285 | RECRUITING | Sleep

Magnesium-L-Threonate for Sleep Quality Post-Arthroplasty
Sponsor:

University of Miami

Information provided by (Responsible Party):

Victor Hugo Hernandez

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

Condition or disease

Sleep

Knee Osteoarthritis

Intervention/treatment

Magnesium Threonate

Control

Phase

PHASE4

Study Type : INTERVENTIONAL
Estimated Enrollment : 64 participants
Masking : DOUBLE
Primary Purpose : SUPPORTIVE_CARE
Official Title : Use of Magnesium-L-Threonate to Improve Subjective Sleep Quality After Total Joint Arthroplasties: Randomized Controlled Clinical Trial
Actual Study Start Date : 2025-04-21
Estimated Primary Completion Date : 2026-05-01
Estimated Study Completion Date : 2026-05-01

Information not available for Arms and Intervention/treatment

Ages Eligible for Study: 18 Years
Sexes Eligible for Study: ALL
Accepts Healthy Volunteers:
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
Magnesium-L-Threonate for Sleep Quality Post-Arthroplasty

Location Details

NCT06902285

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How to Participate

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Locations

RECRUITING

United States, Florida

University of Miami Hospital

Miami, florida, United States, 33136