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Total Joint Arthroplasty and Sleep

NCT03968939 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 55

Last updated 2024-07-16

Study results available
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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.

Conditions

  • Primary Total Hip Arthroplasty
  • Primary Total Knee Arthroplasty

Interventions

DRUG

Diphenhydramine (Benadryl)

Oral Diphenhydramine (Benadryl), 25 mg

DIETARY_SUPPLEMENT

Melatonin

Oral Melatonin, 3 mg

BEHAVIORAL

Sleep Hygiene Education

Brochure containing information about getting a "good night's sleep."

Sponsors & Collaborators

  • James A. Keeney

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-10-01
Primary Completion
2022-03-01
Completion
2022-05-22
FDA Drug
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03968939 on ClinicalTrials.gov