Trial Outcomes & Findings for Melatonin Use After Primary Total Joint Arthroplasty (NCT NCT04795336)
NCT ID: NCT04795336
Last Updated: 2025-05-04
Results Overview
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'.
Recruitment status
COMPLETED
Study phase
PHASE1
Target enrollment
294 participants
Primary outcome timeframe
Visit 1 (Screening Visit), Visit 2 (2 months post surgery)
Results posted on
2025-05-04
Participant Flow
Participant milestones
| Measure |
Knee Cohort
In 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 recruited into intervention group. Intervention group will receive a 5mg Melatonin prescription for 14 days
Melatonin 5 mg: 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
|
Knee Cohort Control
In 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 recruited into placebo group. Control group will receive a placebo pill for 14 days
Placebo: The placebo ingredients are Microcrystalline Cellulose, Silica, Gelatin, Titanium Dioxide, Red #3, and Blue #1.
|
Hip Cohort
In the cohort of patients undergoing primary elective total hip, participants are recruited from those who are willing to consent and participate in the study, and will be randomly recruited into intervention group. Intervention group will receive a 5mg Melatonin prescription for 14 days
Melatonin 5 mg: 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
|
Hip Cohort Control
In the cohort of patients undergoing primary elective total hip, participants are recruited from those who are willing to consent and participate in the study, and will be randomly recruited into placebo group. Control group will receive a placebo pill for 14 days
Placebo: The placebo ingredients are Microcrystalline Cellulose, Silica, Gelatin, Titanium Dioxide, Red #3, and Blue #1.
|
|---|---|---|---|---|
|
Overall Study
STARTED
|
69
|
69
|
78
|
78
|
|
Overall Study
COMPLETED
|
64
|
64
|
75
|
64
|
|
Overall Study
NOT COMPLETED
|
5
|
5
|
3
|
14
|
Reasons for withdrawal
| Measure |
Knee Cohort
In 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 recruited into intervention group. Intervention group will receive a 5mg Melatonin prescription for 14 days
Melatonin 5 mg: 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
|
Knee Cohort Control
In 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 recruited into placebo group. Control group will receive a placebo pill for 14 days
Placebo: The placebo ingredients are Microcrystalline Cellulose, Silica, Gelatin, Titanium Dioxide, Red #3, and Blue #1.
|
Hip Cohort
In the cohort of patients undergoing primary elective total hip, participants are recruited from those who are willing to consent and participate in the study, and will be randomly recruited into intervention group. Intervention group will receive a 5mg Melatonin prescription for 14 days
Melatonin 5 mg: 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
|
Hip Cohort Control
In the cohort of patients undergoing primary elective total hip, participants are recruited from those who are willing to consent and participate in the study, and will be randomly recruited into placebo group. Control group will receive a placebo pill for 14 days
Placebo: The placebo ingredients are Microcrystalline Cellulose, Silica, Gelatin, Titanium Dioxide, Red #3, and Blue #1.
|
|---|---|---|---|---|
|
Overall Study
Withdrawal by Subject
|
3
|
4
|
3
|
12
|
|
Overall Study
Lost study logs
|
0
|
1
|
0
|
2
|
|
Overall Study
Did not take study medication
|
2
|
0
|
0
|
0
|
Baseline Characteristics
Melatonin Use After Primary Total Joint Arthroplasty
Baseline characteristics by cohort
| Measure |
Knee Cohort
n=64 Participants
In 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 recruited into intervention group. Intervention group will receive a 5mg Melatonin prescription for 14 days
Melatonin 5 mg: 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
|
Knee Cohort Control
n=64 Participants
In 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 recruited into placebo group. Control group will receive a placebo pill for 14 days
Placebo: The placebo ingredients are Microcrystalline Cellulose, Silica, Gelatin, Titanium Dioxide, Red #3, and Blue #1.
|
Hip Cohort
n=75 Participants
In the cohort of patients undergoing primary elective total hip, participants are recruited from those who are willing to consent and participate in the study, and will be randomly recruited into intervention group. Intervention group will receive a 5mg Melatonin prescription for 14 days
Melatonin 5 mg: 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
|
Hip Cohort Control
n=64 Participants
In the cohort of patients undergoing primary elective total hip, participants are recruited from those who are willing to consent and participate in the study, and will be randomly recruited into placebo group. Control group will receive a placebo pill for 14 days
Placebo: The placebo ingredients are Microcrystalline Cellulose, Silica, Gelatin, Titanium Dioxide, Red #3, and Blue #1.
|
Total
n=267 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|
|
Age, Continuous
|
64.1 years
n=5 Participants
|
67.6 years
n=7 Participants
|
62.7 years
n=5 Participants
|
62.6 years
n=4 Participants
|
63.9 years
n=21 Participants
|
|
Sex: Female, Male
Female
|
48 Participants
n=5 Participants
|
41 Participants
n=7 Participants
|
48 Participants
n=5 Participants
|
40 Participants
n=4 Participants
|
177 Participants
n=21 Participants
|
|
Sex: Female, Male
Male
|
16 Participants
n=5 Participants
|
23 Participants
n=7 Participants
|
27 Participants
n=5 Participants
|
24 Participants
n=4 Participants
|
90 Participants
n=21 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
5 Participants
n=4 Participants
|
8 Participants
n=21 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
64 Participants
n=5 Participants
|
64 Participants
n=7 Participants
|
72 Participants
n=5 Participants
|
59 Participants
n=4 Participants
|
259 Participants
n=21 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Race (NIH/OMB)
Asian
|
4 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
3 Participants
n=4 Participants
|
13 Participants
n=21 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Race (NIH/OMB)
Black or African American
|
14 Participants
n=5 Participants
|
13 Participants
n=7 Participants
|
10 Participants
n=5 Participants
|
6 Participants
n=4 Participants
|
43 Participants
n=21 Participants
|
|
Race (NIH/OMB)
White
|
43 Participants
n=5 Participants
|
38 Participants
n=7 Participants
|
54 Participants
n=5 Participants
|
46 Participants
n=4 Participants
|
181 Participants
n=21 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
3 Participants
n=5 Participants
|
12 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
9 Participants
n=4 Participants
|
30 Participants
n=21 Participants
|
|
Region of Enrollment
United States
|
64 participants
n=5 Participants
|
64 participants
n=7 Participants
|
75 participants
n=5 Participants
|
64 participants
n=4 Participants
|
267 participants
n=21 Participants
|
PRIMARY outcome
Timeframe: 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'.
Outcome measures
| Measure |
Knee Cohort
n=64 Participants
In 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 recruited into intervention group. Intervention group will receive a 5mg Melatonin prescription for 14 days
Melatonin 5 mg: 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
|
Knee Cohort Control
n=64 Participants
In 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 recruited into placebo group. Control group will receive a placebo pill for 14 days
Placebo: The placebo ingredients are Microcrystalline Cellulose, Silica, Gelatin, Titanium Dioxide, Red #3, and Blue #1.
|
Hip Cohort
n=75 Participants
In the cohort of patients undergoing primary elective total hip, participants are recruited from those who are willing to consent and participate in the study, and will be randomly recruited into intervention group. Intervention group will receive a 5mg Melatonin prescription for 14 days
Melatonin 5 mg: 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
|
Hip Cohort Control
n=64 Participants
In the cohort of patients undergoing primary elective total hip, participants are recruited from those who are willing to consent and participate in the study, and will be randomly recruited into placebo group. Control group will receive a placebo pill for 14 days
Placebo: The placebo ingredients are Microcrystalline Cellulose, Silica, Gelatin, Titanium Dioxide, Red #3, and Blue #1.
|
|---|---|---|---|---|
|
Change in Sleep Disturbance as Measured by Epworth Sleep Score (ESS)
|
7.2 score on a scale
Standard Deviation 4.4
|
6.2 score on a scale
Standard Deviation 4.1
|
6 score on a scale
Standard Deviation 4
|
6.8 score on a scale
Standard Deviation 4.5
|
SECONDARY outcome
Timeframe: Visit 1 (Screening Visit), 14 days after surgery visitThe 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.
Outcome measures
| Measure |
Knee Cohort
n=64 Participants
In 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 recruited into intervention group. Intervention group will receive a 5mg Melatonin prescription for 14 days
Melatonin 5 mg: 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
|
Knee Cohort Control
n=64 Participants
In 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 recruited into placebo group. Control group will receive a placebo pill for 14 days
Placebo: The placebo ingredients are Microcrystalline Cellulose, Silica, Gelatin, Titanium Dioxide, Red #3, and Blue #1.
|
Hip Cohort
n=75 Participants
In the cohort of patients undergoing primary elective total hip, participants are recruited from those who are willing to consent and participate in the study, and will be randomly recruited into intervention group. Intervention group will receive a 5mg Melatonin prescription for 14 days
Melatonin 5 mg: 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
|
Hip Cohort Control
n=64 Participants
In the cohort of patients undergoing primary elective total hip, participants are recruited from those who are willing to consent and participate in the study, and will be randomly recruited into placebo group. Control group will receive a placebo pill for 14 days
Placebo: The placebo ingredients are Microcrystalline Cellulose, Silica, Gelatin, Titanium Dioxide, Red #3, and Blue #1.
|
|---|---|---|---|---|
|
Change in Patient-Reported Outcomes Measurement Information System (PROMIS) Sleep Disturbance Score
|
4.6 score on a scale
Standard Deviation 8.2
|
4 score on a scale
Standard Deviation 8.4
|
0.3 score on a scale
Standard Deviation 9.8
|
2.1 score on a scale
Standard Deviation 9.8
|
Adverse Events
Knee Cohort
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Knee Cohort Control
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Hip Cohort
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Hip Cohort Control
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place