Phase 4
Completed N=55
Total Joint Arthroplasty and Sleep
Primary Total Hip Arthroplasty · Primary Total Knee Arthroplasty
Source: ClinicalTrials.gov NCT03968939 ↗
Enrolled (actual)
55
Serious AEs
0.0%
Results posted
Jul 2024
Primary outcomePrimary: Epworth Sleepiness Scale (ESS) — 7.73; 7.81; 8.36; 7.31 score on a scale
◆ Published Evidence
No publication linked
No peer-reviewed publication reporting this trial's results has been linked yet. This can indicate results are unpublished — a known publication-bias signal. We re-check periodically.
Summary
To compare non-prescription sleep aids (low-dose diphenhydramine and melatonin) to sleep hygiene education for improving postoperative sleep quality after total joint arthroplasty.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Epworth Sleepiness Scale (ESS) |
7.73; 7.81; 8.36; 7.31; 8.17; 7.30 | — |
| PRIMARY Pittsburgh Sleep Quality Index (PSQI) |
10.13; 10.96; 12.14; 9.46; 13.17; 12.55 | — |
| PRIMARY Visual Analogue Scale (VAS) for Pain |
4.67; 4.46; 6.21; 4.31; 3.67; 4.09 | — |
Eligibility Criteria
Inclusion Criteria
All patients undergoing elective primary total hip or knee arthroplasty
Exclusion Criteria
- History of substance abuse
- Workman's compensation patients
- Revision joint replacement
- History of prescription or over-the- counter sleep aid use
Data sourced from ClinicalTrials.gov (NCT03968939). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.