Trial · NCT04795336
Melatonin Use After Primary Total Joint Arthroplasty
NCT04795336, Phase 1, Completed, NYU Langone Health; results first posted 2025-05-04
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Melatonin Use After Primary Total Joint Arthroplasty. Trials, record NCT04795336. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT04795336
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Melatonin Use After Primary Total Joint Arthroplasty
- NCT number
- NCT04795336
- Status
- Completed
- Phases
- Phase 1
- Enrollment
- 294 participants, actual
- Lead sponsor
- NYU Langone Health
- Conditions
- Osteo Arthritis Knee
- Interventions
- Melatonin 5 mg, Placebo
- First posted
- 2021-03-12
- Last updated
- 2025-05-04
- Results first posted
- 2025-05-04
Source ClinicalTrials.gov
Registered outcomes2
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Change in Sleep Disturbance as Measured by Epworth Sleep Score (ESS) | 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 | Change in Patient-Reported Outcomes Measurement Information System (PROMIS) Sleep Disturbance Score | 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. |
Source ClinicalTrials.gov
Outcomes2
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Change in Sleep Disturbance as Measured by Epworth Sleep Score (ESS) | Visit 1 (Screening Visit), Visit 2 (2 months post surgery) | score on a scale | MEAN | |
| SECONDARY | Change in Patient-Reported Outcomes Measurement Information System (PROMIS) Sleep Disturbance Score | Visit 1 (Screening Visit), 14 days after surgery visit | score on a scale | MEAN |
Source ClinicalTrials.gov
Results by group8
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Change in Sleep Disturbance as Measured by Epworth Sleep Score (ESS) | Knee Cohort | 7.2 | Standard Deviation 4.4 | score on a scale | |
| Change in Sleep Disturbance as Measured by Epworth Sleep Score (ESS) | Knee Cohort Control | 6.2 | Standard Deviation 4.1 | score on a scale | |
| Change in Sleep Disturbance as Measured by Epworth Sleep Score (ESS) | Hip Cohort | 6 | Standard Deviation 4 | score on a scale | |
| Change in Sleep Disturbance as Measured by Epworth Sleep Score (ESS) | Hip Cohort Control | 6.8 | Standard Deviation 4.5 | score on a scale | |
| Change in Patient-Reported Outcomes Measurement Information System (PROMIS) Sleep Disturbance Score | Knee Cohort | 4.6 | Standard Deviation 8.2 | score on a scale | |
| Change in Patient-Reported Outcomes Measurement Information System (PROMIS) Sleep Disturbance Score | Knee Cohort Control | 4 | Standard Deviation 8.4 | score on a scale | |
| Change in Patient-Reported Outcomes Measurement Information System (PROMIS) Sleep Disturbance Score | Hip Cohort | 0.3 | Standard Deviation 9.8 | score on a scale | |
| Change in Patient-Reported Outcomes Measurement Information System (PROMIS) Sleep Disturbance Score | Hip Cohort Control | 2.1 | Standard Deviation 9.8 | score on a scale |
Source ClinicalTrials.gov
Participant flow12
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Knee Cohort | 69 | |
| Overall Study | STARTED | Knee Cohort Control | 69 | |
| Overall Study | STARTED | Hip Cohort | 78 | |
| Overall Study | STARTED | Hip Cohort Control | 78 | |
| Overall Study | COMPLETED | Knee Cohort | 64 | |
| Overall Study | COMPLETED | Knee Cohort Control | 64 | |
| Overall Study | COMPLETED | Hip Cohort | 75 | |
| Overall Study | COMPLETED | Hip Cohort Control | 64 | |
| Overall Study | NOT COMPLETED | Knee Cohort | 5 | |
| Overall Study | NOT COMPLETED | Knee Cohort Control | 5 |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 participant flowAdverse events0
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
None in this release.
Adverse event totals12
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Knee Cohort | 0 | 64 |
| Total, all-cause mortality | Knee Cohort Control | 0 | 64 |
| Total, all-cause mortality | Hip Cohort | 0 | 75 |
| Total, all-cause mortality | Hip Cohort Control | 0 | 64 |
| Total, other adverse events | Knee Cohort | 0 | 64 |
| Total, other adverse events | Knee Cohort Control | 0 | 64 |
| Total, other adverse events | Hip Cohort | 0 | 75 |
| Total, other adverse events | Hip Cohort Control | 0 | 64 |
| Total, serious adverse events | Knee Cohort | 0 | 64 |
| Total, serious adverse events | Knee Cohort Control | 0 | 64 |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 adverse event totalsPapers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 38401621 | DERIVED |
Source PubMed
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT04795336
GET https://conductscience.org/api/trials/v1/NCT04795336/registered