Phase 4 N=55 Randomized Double-blind Treatment

Total Joint Arthroplasty and Sleep

Primary Total Hip Arthroplasty · Primary Total Knee Arthroplasty

Bottom Line

View on ClinicalTrials.gov: NCT03968939 ↗

Enrolled (actual)

Serious AEs

0.0%

Results posted

Jul 2024

Primary outcome: Primary: Epworth Sleepiness Scale (ESS) — 7.73; 7.81; 8.36; 7.31 score on a scale

Study Design & Population

Study type: Interventional
Phase: Phase 4
Interventions: Diphenhydramine (Benadryl) (Drug); Melatonin (Dietary_supplement); Sleep Hygiene Education (Behavioral)
Age: Adult, Older Adult · 18+ yrs
Sex: All
Sponsor: James A. Keeney
Primary completion: Mar 2022

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	—

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.

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

View full record on ClinicalTrials.gov →

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.