18 and older, any sex, with Primary Total Hip Arthroplasty or Primary Total Knee Arthroplasty. Patients with the condition only — healthy volunteers not accepted.
Results — posted to ClinicalTrials.gov
Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.
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.
Baseline
Group
Value
95% CI
Control Group (Usual Care)
7.73
± 4.06
Sleep Hygiene Education
7.81
± 5.04
Over-the-counter Sleep Aids (25 mg Benadryl + 3mg Melatonin)
8.36
± 5.51
2 Week Follow Up
Group
Value
95% CI
Control Group (Usual Care)
7.31
± 3.66
Sleep Hygiene Education
8.17
± 3.76
Over-the-counter Sleep Aids (25 mg Benadryl + 3mg Melatonin)
7.30
± 4.67
6 Week Follow Up
Group
Value
95% CI
Control Group (Usual Care)
8.00
± 4.26
Sleep Hygiene Education
8.36
± 4.82
Over-the-counter Sleep Aids (25 mg Benadryl + 3mg Melatonin)
6.17
± 2.21
12 Week Follow Up
Group
Value
95% CI
Control Group (Usual Care)
6.40
± 3.17
Sleep Hygiene Education
6.68
± 3.74
Over-the-counter Sleep Aids (25 mg Benadryl + 3mg Melatonin)
8.13
± 6.10
Pittsburgh Sleep Quality Index (PSQI)Primary· Baseline, 2 weeks, 6 weeks and 12 weeks post-op
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
Baseline
Group
Value
95% CI
Control Group (Usual Care)
10.13
± 4.44
Sleep Hygiene Education
10.96
± 4.77
Over-the-counter Sleep Aids (25 mg Benadryl + 3mg Melatonin)
12.14
± 6.00
2 Weeks Follow Up
Group
Value
95% CI
Control Group (Usual Care)
9.46
± 3.97
Sleep Hygiene Education
13.17
± 3.50
Over-the-counter Sleep Aids (25 mg Benadryl + 3mg Melatonin)
12.55
± 5.87
6 Weeks Follow Up
Group
Value
95% CI
Control Group (Usual Care)
10.38
± 5.98
Sleep Hygiene Education
11.77
± 3.46
Over-the-counter Sleep Aids (25 mg Benadryl + 3mg Melatonin)
6.81
± 3.74
12 Weeks Follow Up
Group
Value
95% CI
Control Group (Usual Care)
9.4
± 3.53
Sleep Hygiene Education
10.7
± 4.41
Over-the-counter Sleep Aids (25 mg Benadryl + 3mg Melatonin)
7.33
± 3.64
Visual Analogue Scale (VAS) for PainPrimary· Baseline, 2 weeks, 6 weeks and 12 weeks post-op
Patient Reported Outcome Measure - pain Scale: 0-10. 0 being no pain and 10 being unbearable pain
Baseline
Group
Value
95% CI
Control Group (Usual Care)
4.67
± 3.04
Sleep Hygiene Education
4.46
± 2.08
Over-the-counter Sleep Aids (25 mg Benadryl + 3mg Melatonin)
6.21
± 1.93
2 Week Follow Up
Group
Value
95% CI
Control Group (Usual Care)
4.31
± 2.46
Sleep Hygiene Education
3.67
± 2.00
Over-the-counter Sleep Aids (25 mg Benadryl + 3mg Melatonin)
4.09
± 1.87
6 Week Follow Up
Group
Value
95% CI
Control Group (Usual Care)
2.67
± 1.67
Sleep Hygiene Education
2.36
± 1.56
Over-the-counter Sleep Aids (25 mg Benadryl + 3mg Melatonin)
2.45
± 1.81
12 Week Follow Up
Group
Value
95% CI
Control Group (Usual Care)
1.8
± 1.32
Sleep Hygiene Education
2.55
± 1.50
Over-the-counter Sleep Aids (25 mg Benadryl + 3mg Melatonin)
2.78
± 2.95
Sponsor's own description
To compare non-prescription sleep aids (low-dose diphenhydramine and melatonin) to sleep hygiene education for improving postoperative sleep quality after total joint arthroplasty.
Publications & conference data
No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by James A. Keeney
Last refreshed: 16 July 2024
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT03968939.