Trial Outcomes & Findings for Total Joint Arthroplasty and Sleep (NCT NCT03968939)
NCT ID: NCT03968939
Last Updated: 2024-07-16
Results Overview
Epworth Sleepiness Scale is widely used in the field of sleep medicine as a subjective measure of a patient's sleepiness. The test is a list of eight situations in which to rate the participants tendency to become sleepy. * No chance of dozing = 0 * Slight chance of dozing = 1 * Moderate chance of dozing = 2 * High chance of dozing = 3 Total the values of the responses. The total score is based on a scale of 0 to 24. The higher score the higher the chance the participant is experiencing excessive sleepiness.
COMPLETED
PHASE4
55 participants
Baseline, 2 weeks, 6 weeks and 12 weeks post-op
2024-07-16
Participant Flow
Participant milestones
| Measure |
Control Group (Usual Care)
Control Group (Usual Care): Participants do not use any type of sleep education or non-prescription sleep medications to assist with getting a "good night's sleep".
|
Sleep Hygiene Education
Sleep Hygiene Education: Participants are provided a Sleep Hygiene Education Brochure containing information about getting a "good night's sleep."
|
Over-the-counter Sleep Aids (25 mg Benadryl + 3mg Melatonin)
Participants are given both:
1. Over-the-counter sleep aids:25 mg Diphenhydramine (Benadryl) and 3mg oral melatonin to be taken before bedtime;
2. and a Sleep Hygiene Education Brochure containing information about getting a "good night's sleep."
|
|---|---|---|---|
|
Overall Study
STARTED
|
15
|
26
|
14
|
|
Overall Study
COMPLETED
|
15
|
26
|
14
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Total Joint Arthroplasty and Sleep
Baseline characteristics by cohort
| Measure |
Control Group (Usual Care)
n=15 Participants
Control Group (Usual Care): Participants do not use any type of sleep education or non-prescription sleep medications to assist with getting a "good night's sleep".
|
Sleep Hygiene Education
n=26 Participants
Sleep Hygiene Education: Participants are provided a Sleep Hygiene Education Brochure containing information about getting a "good night's sleep."
|
Over-the-counter Sleep Aids (25 mg Benadryl + 3mg Melatonin)
n=14 Participants
Participants are given both:
1. Over-the-counter sleep aids:25 mg Diphenhydramine (Benadryl) and 3mg oral melatonin to be taken before bedtime;
2. and a Sleep Hygiene Education Brochure containing information about getting a "good night's sleep."
|
Total
n=55 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Continuous
|
67.77 Years
n=5 Participants
|
67.19 Years
n=7 Participants
|
66.47 Years
n=5 Participants
|
66.71 Years
n=4 Participants
|
|
Sex: Female, Male
Female
|
6 Participants
n=5 Participants
|
18 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
27 Participants
n=4 Participants
|
|
Sex: Female, Male
Male
|
9 Participants
n=5 Participants
|
8 Participants
n=7 Participants
|
11 Participants
n=5 Participants
|
28 Participants
n=4 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
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 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
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
White
|
14 Participants
n=5 Participants
|
26 Participants
n=7 Participants
|
14 Participants
n=5 Participants
|
54 Participants
n=4 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
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
|
Region of Enrollment
United States
|
15 participants
n=5 Participants
|
26 participants
n=7 Participants
|
14 participants
n=5 Participants
|
55 participants
n=4 Participants
|
|
Total Joint Arthroplasty (TJA) Cohort
Total Knee Arthroplasty (TKA)
|
9 Participants
n=5 Participants
|
18 Participants
n=7 Participants
|
9 Participants
n=5 Participants
|
36 Participants
n=4 Participants
|
|
Total Joint Arthroplasty (TJA) Cohort
Total Hip Arthroplasty (THA)
|
6 Participants
n=5 Participants
|
8 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
19 Participants
n=4 Participants
|
PRIMARY outcome
Timeframe: Baseline, 2 weeks, 6 weeks and 12 weeks post-opPopulation: Due to attrition, the number analyzed at each time point is the number of participants who followed up with the research team
Epworth Sleepiness Scale is widely used in the field of sleep medicine as a subjective measure of a patient's sleepiness. The test is a list of eight situations in which to rate the participants tendency to become sleepy. * No chance of dozing = 0 * Slight chance of dozing = 1 * Moderate chance of dozing = 2 * High chance of dozing = 3 Total the values of the responses. The total score is based on a scale of 0 to 24. The higher score the higher the chance the participant is experiencing excessive sleepiness.
Outcome measures
| Measure |
Control Group (Usual Care)
n=15 Participants
Control Group (Usual Care): Participants do not use any type of sleep education or non-prescription sleep medications to assist with getting a "good night's sleep".
|
Sleep Hygiene Education
n=26 Participants
Sleep Hygiene Education: Participants are provided a Sleep Hygiene Education Brochure containing information about getting a "good night's sleep."
|
Over-the-counter Sleep Aids (25 mg Benadryl + 3mg Melatonin)
n=14 Participants
Participants are given both:
1. Over-the-counter sleep aids:25 mg Diphenhydramine (Benadryl) and 3mg oral melatonin to be taken before bedtime;
2. and a Sleep Hygiene Education Brochure containing information about getting a "good night's sleep."
|
|---|---|---|---|
|
Epworth Sleepiness Scale (ESS)
Baseline
|
7.73 score on a scale
Standard Deviation 4.06
|
7.81 score on a scale
Standard Deviation 5.04
|
8.36 score on a scale
Standard Deviation 5.51
|
|
Epworth Sleepiness Scale (ESS)
2 Week Follow Up
|
7.31 score on a scale
Standard Deviation 3.66
|
8.17 score on a scale
Standard Deviation 3.76
|
7.30 score on a scale
Standard Deviation 4.67
|
|
Epworth Sleepiness Scale (ESS)
6 Week Follow Up
|
8.00 score on a scale
Standard Deviation 4.26
|
8.36 score on a scale
Standard Deviation 4.82
|
6.17 score on a scale
Standard Deviation 2.21
|
|
Epworth Sleepiness Scale (ESS)
12 Week Follow Up
|
6.40 score on a scale
Standard Deviation 3.17
|
6.68 score on a scale
Standard Deviation 3.74
|
8.13 score on a scale
Standard Deviation 6.10
|
PRIMARY outcome
Timeframe: Baseline, 2 weeks, 6 weeks and 12 weeks post-opPopulation: Due to attrition, the number analyzed at each time point is the number of participants who followed up with the research team
The PSQI measures several different aspects of sleep, offering seven component scores and one composite score. The component scores consist of subjective sleep quality, sleep latency (i.e., how long it takes to fall asleep), sleep duration, habitual sleep efficiency (i.e., the percentage of time in bed that one is asleep), sleep disturbances, use of sleeping medication, and daytime dysfunction. Each item is weighted on a 0-3 interval scale. The global PSQI score is then calculated by totaling the nine component scores, providing an overall score ranging from 0 to 27, where lower scores denote a healthier sleep quality.
Outcome measures
| Measure |
Control Group (Usual Care)
n=15 Participants
Control Group (Usual Care): Participants do not use any type of sleep education or non-prescription sleep medications to assist with getting a "good night's sleep".
|
Sleep Hygiene Education
n=26 Participants
Sleep Hygiene Education: Participants are provided a Sleep Hygiene Education Brochure containing information about getting a "good night's sleep."
|
Over-the-counter Sleep Aids (25 mg Benadryl + 3mg Melatonin)
n=14 Participants
Participants are given both:
1. Over-the-counter sleep aids:25 mg Diphenhydramine (Benadryl) and 3mg oral melatonin to be taken before bedtime;
2. and a Sleep Hygiene Education Brochure containing information about getting a "good night's sleep."
|
|---|---|---|---|
|
Pittsburgh Sleep Quality Index (PSQI)
6 Weeks Follow Up
|
10.38 score on a scale
Standard Deviation 5.98
|
11.77 score on a scale
Standard Deviation 3.46
|
6.81 score on a scale
Standard Deviation 3.74
|
|
Pittsburgh Sleep Quality Index (PSQI)
12 Weeks Follow Up
|
9.4 score on a scale
Standard Deviation 3.53
|
10.7 score on a scale
Standard Deviation 4.41
|
7.33 score on a scale
Standard Deviation 3.64
|
|
Pittsburgh Sleep Quality Index (PSQI)
2 Weeks Follow Up
|
9.46 score on a scale
Standard Deviation 3.97
|
13.17 score on a scale
Standard Deviation 3.50
|
12.55 score on a scale
Standard Deviation 5.87
|
|
Pittsburgh Sleep Quality Index (PSQI)
Baseline
|
10.13 score on a scale
Standard Deviation 4.44
|
10.96 score on a scale
Standard Deviation 4.77
|
12.14 score on a scale
Standard Deviation 6.00
|
PRIMARY outcome
Timeframe: Baseline, 2 weeks, 6 weeks and 12 weeks post-opPopulation: Due to attrition, the number analyzed at each time point is the number of participants who followed up with the research team
Patient Reported Outcome Measure - pain Scale: 0-10. 0 being no pain and 10 being unbearable pain
Outcome measures
| Measure |
Control Group (Usual Care)
n=15 Participants
Control Group (Usual Care): Participants do not use any type of sleep education or non-prescription sleep medications to assist with getting a "good night's sleep".
|
Sleep Hygiene Education
n=26 Participants
Sleep Hygiene Education: Participants are provided a Sleep Hygiene Education Brochure containing information about getting a "good night's sleep."
|
Over-the-counter Sleep Aids (25 mg Benadryl + 3mg Melatonin)
n=14 Participants
Participants are given both:
1. Over-the-counter sleep aids:25 mg Diphenhydramine (Benadryl) and 3mg oral melatonin to be taken before bedtime;
2. and a Sleep Hygiene Education Brochure containing information about getting a "good night's sleep."
|
|---|---|---|---|
|
Visual Analogue Scale (VAS) for Pain
Baseline
|
4.67 score on a scale
Standard Deviation 3.04
|
4.46 score on a scale
Standard Deviation 2.08
|
6.21 score on a scale
Standard Deviation 1.93
|
|
Visual Analogue Scale (VAS) for Pain
2 Week Follow Up
|
4.31 score on a scale
Standard Deviation 2.46
|
3.67 score on a scale
Standard Deviation 2.00
|
4.09 score on a scale
Standard Deviation 1.87
|
|
Visual Analogue Scale (VAS) for Pain
6 Week Follow Up
|
2.67 score on a scale
Standard Deviation 1.67
|
2.36 score on a scale
Standard Deviation 1.56
|
2.45 score on a scale
Standard Deviation 1.81
|
|
Visual Analogue Scale (VAS) for Pain
12 Week Follow Up
|
1.8 score on a scale
Standard Deviation 1.32
|
2.55 score on a scale
Standard Deviation 1.50
|
2.78 score on a scale
Standard Deviation 2.95
|
Adverse Events
Control Group (Usual Care)
Sleep Hygiene Education
Over-the-counter Sleep Aids (25 mg Benadryl + 3mg Melatonin)
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Vicki L Jones
UMissouri - Missouri Orthopaedic Institute
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place