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Completed

NCT Number: NCT04795336

Melatonin Use After Primary Total Joint Arthroplasty

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.

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Key information

Conditions

Osteo Arthritis Knee

Age range

18 year–95 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

NYU Langone Health

New York, 10016, United States

About this study

This will be a single-center randomized double blind placebo control clinical trial. In the cohort of patients undergoing primary elective total hip and the cohort of patients undergoing primary elective knee arthroplasty, participants are recruited from those who are willing to consent and participate in the study, and will be randomly 1:1 divided into intervention group and placebo group.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

Melatonin 5 mg

Drug

Melatonin is a widely sold synthetic molecule in various forms including tablets, gummies and liquid. In the present study, the tablet version of the medication will be used at a dose of 5mg

Placebo

Other

The placebo ingredients are Microcrystalline Cellulose, Silica, Gelatin, Titanium Dioxide, Red #3, and Blue #1.

Primary outcomes

  1. Change in Sleep Disturbance as Measured by Epworth Sleep Score (ESS)

    Time frame: Visit 1 (Screening Visit), Visit 2 (2 months post surgery)

    The primary objective is the Epworth Sleep Score used to evaluate the impact of melatonin use on the quality of sleep, including total hours of sleep and nighttime awakenings in patients undergoing elective primary total hip and knee arthroplasty. The ESS score (the sum of 8 item scores, 0-3) can range from 0 to 24. The higher the ESS score, the higher that person's average sleep propensity in daily life (ASP), or their 'daytime sleepiness'.

Secondary outcomes

  1. Change in Patient-Reported Outcomes Measurement Information System (PROMIS) Sleep Disturbance Score

    Time frame: Visit 1 (Screening Visit), 14 days after surgery visit

    The PROMIS Sleep Disturbance questionnaire comprises 8 items assessing patients' sleep over the past 7 days. Each item is rated on a Likert scale from 1-5. The raw score is the sum of responses and is transformed to a normalized score from 0-100; higher scores indicate greater sleep disturbance.

Sponsors and collaborators

Lead sponsor

NYU Langone Health

Other

Registry information

Official study title

Melatonin Use After Primary Total Joint Arthroplasty: A Randomized, Double Blind Placebo-Controlled Trial

Important dates

Study start
2021
Primary completion
2024
Study completion
2024
First posted
Mar 12, 2021
Registry last updated
May 4, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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