Melatonin 5 mg for Sleep Disorders

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
Patients undergoing primary, unilateral TKA
Primary diagnosis of osteoarthritis (OA)
Must not have
Be younger than 18 years old
Screening 3 weeks
Treatment Varies
Follow Up1-year
Awards & highlights

Study Summary

This trial will compare the effects of melatonin vs. placebo in patients undergoing primary total knee arthroplasty. The goal is to see if melatonin can improve postoperative sleep quality and if improved sleep quality correlates to better postoperative outcomes.

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

Eligibility Criteria

Inclusion Criteria

You will be eligible if you check “Yes” for the criteria below
You are having a knee replacement surgery on one knee only.
You have been diagnosed with osteoarthritis (OA) as your main medical condition.
You are not taking any medication to help you sleep currently.


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

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Sleep Quality
Secondary outcome measures
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.
First Studied
Drug Approval Stage
How many patients have taken this drug
Melatonin 5 mg
Completed Phase 4

Find a site

Who is running the clinical trial?

Hospital for Special Surgery, New YorkLead Sponsor
236 Previous Clinical Trials
61,426 Total Patients Enrolled
Alejandro G Della Valle, MDPrincipal Investigator
Hospital for Special Surgery, New York

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Can patients currently join this clinical exploration?

"Data hosted on indicates that this trial, which was first unveiled on January 10th 2022, is currently seeking participants. The page was last updated on August 25th 2022."

Answered by AI

What is the sample size for this clinical experiment?

"Affirmative, according to this medical investigation is actively seeking volunteers. It was first made available on the 10th of January 2022 and recently updated on the 25th of August 2022. 152 participants are needed at 1 site for inclusion in this trial."

Answered by AI

Who else is applying?

What state do they live in?
How old are they?
18 - 65
What portion of applicants met pre-screening criteria?
Did not meet criteria
Recent research and studies
~66 spots leftby Oct 2024