Phase 1 N=294 Randomized Double-blind Treatment

Melatonin Use After Primary Total Joint Arthroplasty

Osteo Arthritis Knee

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View on ClinicalTrials.gov: NCT04795336 ↗

Enrolled (actual)

294

Serious AEs

0.0%

Results posted

May 2025

Primary outcome: Primary: Change in Sleep Disturbance as Measured by Epworth Sleep Score (ESS) — 7.2; 6.2; 6; 6.8 score on a scale

Study Design & Population

Study type: Interventional
Phase: Phase 1
Interventions: Melatonin 5 mg (Drug); Placebo (Other)
Age: Adult, Older Adult · 18+ yrs
Sex: All
Sponsor: NYU Langone Health
Primary completion: Apr 2024

Outcome Measures

Outcome	Result	p-value
PRIMARY Change in Sleep Disturbance as Measured by Epworth Sleep Score (ESS)	7.2; 6.2; 6; 6.8	—
SECONDARY Change in Patient-Reported Outcomes Measurement Information System (PROMIS) Sleep Disturbance Score	4.6; 4; 0.3; 2.1	—

Summary

The purpose of this study is to determine the effect of melatonin supplementation on patient sleep quality, length of stay, and opioid consumption following primary, unilateral, elective total hip or knee arthroplasty.

Eligibility Criteria

Inclusion Criteria

Patient are current candidates for elective primary total hip and total knee arthroplasty.
Patients ≥18 years of age but ≤ 95
Patients have been medically cleared and scheduled for surgery

Exclusion Criteria

Non-elective conversion arthroplasty
Bilateral total joint arthroplasty
Contraindications to use of melatonin (diabetes, calcium channel blocker use, depression)
Conditions and medications likely to confound results due to impact on subjective and/or objective sleep quality (insomnia, drug/alcohol abuse, and use of benzodiazepines, and prescription sleep aids)
Conditions likely to impair capacity to adhere to protocol (mental impairment, psychiatric disorders other than anxiety/depression)

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT04795336). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.