NCT03879707

Improving Sleep Quality After Total Joint Arthroplasty ( TJA)

• Status: Withdrawn
• Phase: EARLY_Phase 1
• Study type: Interventional
• Enrollment: 0 (actual)
• Sponsor: Stanford University · Academic / Other
• Sex: All
• Age: 18 Years – 99 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is the evaluate and improve sleep quality after Total joint replacement.

Detailed description

Patients in early stage after TKA tend to suffer from sleep problem. Sleep disturbances frequently occur in patients after surgery, and its occurrence is harmful for postoperative recovery. Many factors can affect the quality of sleep after a major surgery including anesthesia-type, narcotic use and discomfort due to pain or restricted leg movements. Pain directly leads to sleep disruption or even deprivation and, in turn, poor-quality sleep aggravates pain sensation. There seems to be a vicious circle: pain - poor-quality sleep - intensified pain - even poorer-quality sleep. Presumably, if a patient suffers from catastrophizing, depression and anxiety , the result of TKA will be worse due to poor sleep.

Conditions

• Pain After TJA

Interventions

Type	Name	Description
DRUG	Melatonin 5 mg	Melatonin is known to induce sleep
DRUG	Placebo Oral Tablet	Placebo
DRUG	Magnesium 500Mg Oral Tablet	Magnesium plays a role in supporting deep, restorative sleep by maintaining healthy levels of GABA, a neurotransmitter that promotes sleep. Research indicates supplemental magnesium can improve sleep quality, especially in people with poor sleep

Timeline

• Start date: 2025-06-01
• Primary completion: 2028-06-01
• Completion: 2028-06-01
• First posted: 2019-03-19
• Last updated: 2025-04-11

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study