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TKA Melatonin and Sleep Quality

N/A
Waitlist Available
Led By Alejandro G Della Valle, MD
Research Sponsored by Hospital for Special Surgery, New York
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 1-year

Summary

This trial will test if taking a melatonin pill can improve sleep quality in patients who have had knee replacement surgery. Melatonin helps regulate the sleep-wake cycle, and the study aims to see if it can help these patients sleep better after their operation. Melatonin has been studied for its potential to improve sleep quality in various populations, including surgical patients.

Eligible Conditions
  • Insomnia
  • Sleep Disorders
  • Joint Replacement Surgery
  • Replacement
  • Knee

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~1-year
This trial's timeline: 3 weeks for screening, Varies for treatment, and 1-year for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Sleep Quality
Secondary study objectives
Knee Function
Lower Extremity Activity
Opioids Prescribed
+5 more

Trial Design

2Treatment groups
Experimental Treatment
Placebo Group
Group I: Melatonin Group (Experimental)Experimental Treatment1 Intervention
Patients who will take one (1) 5mg Melatonin tablet 30 minutes before bedtime daily for the 6 weeks following surgery.
Group II: Placebo Group (Control)Placebo Group1 Intervention
Patients who will take one (1) placebo (Vitamin C) tablet 30 minutes before bedtime daily for the 6 weeks following surgery.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Melatonin 5 mg
2016
Completed Phase 4
~500

Find a Location

Who is running the clinical trial?

Hospital for Special Surgery, New YorkLead Sponsor
250 Previous Clinical Trials
61,160 Total Patients Enrolled
Alejandro G Della Valle, MDPrincipal InvestigatorHospital for Special Surgery, New York
~45 spots leftby Dec 2025
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