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NCT04795336 · ClinicalTrials.gov registry record · Phase 1
Melatonin Use After Primary Total Joint Arthroplasty
A Phase 1 study of Osteoarthritis, Knee, sponsored by NYU Langone Health.
- Completed
- Registry status
- Phase 1
- Development phase
- 294
- Enrollment target
- 1
- Study location
NCT04795336: Completed Phase 1 study of Osteoarthritis, Knee, sponsored by NYU Langone Health.
NCT04795336 is a Phase 1 study of Osteoarthritis, Knee that has completed, run by NYU Langone Health. The registered enrollment target is 294 participants, below the 495-participant average among 112 other Osteoarthritis, Knee trials with a reported enrollment target (41% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04795336, a Phase 1 study of Osteoarthritis, Knee, has completed, sponsored by NYU Langone Health.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 294 participants
- Enrollment target
- 1
- Study location
Study 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.
Primary Outcome
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'.
Conditions Studied
Interventions
- OTHER Placebo
- DRUG Melatonin 5 mg
Study Locations (1)
New York
- NYU Langone Health - New York
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 294 participants |
| Start Date | 2021-07-12 |
| Est. Completion | 2024-04-18 |
| Phase | Phase 1 |
What the finished NCT04795336 record still lists
NCT04795336 is an interventional study that assigns participants to a tested intervention. The registered 294 participants enrollment target is mid-sized for trials with a published cap, below the 495-participant average among 112 other Osteoarthritis, Knee trials with a reported enrollment target (41% lower).
The record links to 1 condition, with Osteoarthritis, Knee appearing as the primary indexed condition, and to 2 interventions - of which Placebo is the first listed.
NCT04795336 reports a single indexed study location in New York.
Frequently Asked Questions
What is clinical trial NCT04795336 about?
NCT04795336 is a clinical study titled "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.
What is the current status of trial NCT04795336?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 294 participants. The study started on 2021-07-12. Estimated completion is 2024-04-18.
What conditions does trial NCT04795336 study?
This clinical trial studies the following conditions: Osteoarthritis, Knee.
What interventions are being tested in trial NCT04795336?
The interventions under investigation include: Placebo (OTHER), Melatonin 5 mg (DRUG).
Who is sponsoring clinical trial NCT04795336?
This trial is sponsored by NYU Langone Health, which has 1,164 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT04795336 being conducted?
This trial has 1 study location across New York. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Osteoarthritis, Knee
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT04795336's enrollment target sits among peer trials
294 27th of 112 higher than 86 of 112 other Osteoarthritis, Knee trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Osteoarthritis, Knee trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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