SleepPhase 4NCT06902285
Magnesium-L-Threonate for Sleep Quality Post-Arthroplasty
A Phase 4 study testing Magnesium Threonate in people with Sleep and Knee Osteoarthritis, run by University of Miami at 1 site in United States.
Trial 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 Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Sleep, Knee Osteoarthritis
- What is being tested?
- Magnesium Threonate
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 64 participants
- Where
- 1 siteUnited States
- Study dates
- 21 Apr 2025to 1 Jul 2027
- Phase
- Phase 4
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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.
Show all 11Show fewer
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
University of Miami Hospital
Miami, Florida, 33136
Natalia Cruz, MD
Jonathan Stern, MD
About this study
Official title: Use of Magnesium-L-Threonate to Improve Subjective Sleep Quality After Total Joint Arthroplasties: Randomized Controlled Clinical Trial
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
- Conditions
- Sleep, Knee Osteoarthritis
- Being tested
- Magnesium Threonate, Control
- Medical subject headings
- Osteoarthritis, Knee
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Magnesium ThreonateDrug
Participants will receive a daily 145 mg pill by mouth 30 minutes before going to sleep
ControlOther
Participants will receive two sugar pills daily by mouth 30 minutes before going to sleep
| Study group | Role | What they receive |
|---|---|---|
| Magnesium L Threonate Group | Experimental | Participants in this group will receive the Magnesium L Threonate intervention for up to 6 weeks postoperatively Receives: Drug: Magnesium Threonate |
| Control Group | Placebo comparator | Participants in this group will receive the placebo comparator for up to 6 weeks postoperatively Receives: Other: Control |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Epsworth Sleepiness Score
Score ranging from 0-24 with higher scores indicating greater sleepiness.
Measured: 2 weeks, 4 weeks, 6 weeks
Change in Pittsburgh Sleep Quality Index (PSQI)
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
Measured: 2 weeks, 4 weeks, 6 weeks
Secondary outcomes (3)
Change in Morphine Milligram Equivalent Prescribed
Measured in milligram equivalents
Measured: 2 weeks, 4 weeks, 6 weeks
Patient-reported outcome measured by Knee Injury and Osteoarthritis Outcome Score
The total score ranges from 0-100. Lowers scores indicate a healthier knee
Measured: 6 weeks
Medication Compliance measured in number of days study medication taken
Medication compliance as measured by number of days taking study medication
Measured: 6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Mar 2025
- Study start21 Apr 2025
- Primary completion1 Jul 2027 (estimated)
- Study completion1 Jul 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for SleepStudies of the same condition, open and under way.
- More trials run by University of MiamiThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 64 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Miami
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Victor Hugo Hernandez, University of Miami
- Investigators
- Victor H Hernandez, MD, Principal investigator, University of Miami
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06902285
- Sponsor's protocol ID
- 20240578
- Status last verified
- Jul 2026
- First submitted
- 24 Mar 2025
- Last updated
- 9 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Use of Magnesium-L-Threonate to Improve Subjective Sleep Quality After Total Joint Arthroplasties: Randomized Controlled Clinical Trial
- ClinicalTrials.gov ID
- NCT06902285
- Acronym / sponsor ID
- 20240578
- Conditions
- Sleep, Knee Osteoarthritis
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 64 participants (estimated)
- Lead sponsor
- University of MiamiUniversity, hospital or other
- Study start
- 21 Apr 2025 (actual)
- Primary completion
- 1 Jul 2027 (estimated)
- Study completion
- 1 Jul 2027 (estimated)
- First posted
- 30 Mar 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Magnesium L Threonate Group | Experimental | Drug: Magnesium ThreonateParticipants in this group will receive the Magnesium L Threonate intervention for up to 6 weeks postoperatively |
| Control Group | Placebo comparator | Other: ControlParticipants in this group will receive the placebo comparator for up to 6 weeks postoperatively |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (11 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Magnesium ThreonateParticipants will receive a daily 145 mg pill by mouth 30 minutes before going to sleep | Drug | Magnesium L Threonate Group |
| ControlParticipants will receive two sugar pills daily by mouth 30 minutes before going to sleep | Other | Control Group |
Primary outcome
Change in Epsworth Sleepiness Score
Time frame: 2 weeks, 4 weeks, 6 weeks
Score ranging from 0-24 with higher scores indicating greater sleepiness.
Change in Pittsburgh Sleep Quality Index (PSQI)
Time frame: 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
3 secondary outcomes
Change in Morphine Milligram Equivalent Prescribed
Time frame: 2 weeks, 4 weeks, 6 weeks
Patient-reported outcome measured by Knee Injury and Osteoarthritis Outcome Score
Time frame: 6 weeks
Medication Compliance measured in number of days study medication taken
Time frame: 6 weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Jul 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Victor H Hernandez, MD principal investigator
University of Miami
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Magnesium Threonate in people with Sleep and Knee Osteoarthritis, run by University of Miami at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 9 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Victor H Hernandez, MD (305-689-5195, vhh1@miami.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Epsworth Sleepiness Score (time frame: 2 weeks, 4 weeks, 6 weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Jul 2026.