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Joint surgery patients sought for sleep aid study

NCT ID NCT06902285

Symptom relief Sponsor: University of Miami Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jul 10, 2026 · Updated 2 times

Summary

This study tests whether a magnesium supplement called Magnesium-L-Threonate (MgT) can improve sleep quality and reduce pain in people recovering from total knee or hip replacement. Researchers will enroll 64 adults having surgery at the University of Miami Hospital. Participants take MgT and report changes in sleepiness, sleep quality, pain, and medication use.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 4

Runs after approval, following long-term safety and how well the treatment works in everyday use.

Participants

About 64 people

The number the study aims to enrol. It can still change while the study runs.

Started

Apr 2025

Expected to finish

Jul 2027

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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

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Conditions

The condition(s) this trial relates to.

osteoarthritis, hip osteoarthritis, knee sleep disorder

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Knee osteoarthritis Sleep

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    1 site. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • University of Miami Hospital

    RECRUITING

    Miami, Florida, 33136, United States

More trials for these conditions

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