Total Joint Arthroplasty and Sleep

NCT03968939 | Completed Phase 4 Results FDA Drug

• 1 other identifier: 2013726
• Study Type: interventional
• Target: 55
• Locations: 1 country
• Sites: 1

Brief 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

Outcome Measures

Primary Outcomes (3)

• Epworth Sleepiness Scale (ESS)

  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, 2 weeks, 6 weeks and 12 weeks post-op

• Pittsburgh Sleep Quality Index (PSQI)

  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.

  Baseline, 2 weeks, 6 weeks and 12 weeks post-op

• Visual Analogue Scale (VAS) for Pain

  Patient Reported Outcome Measure - pain Scale: 0-10. 0 being no pain and 10 being unbearable pain

  Baseline, 2 weeks, 6 weeks and 12 weeks post-op

Study Arms (3)

Control group (Usual Care)

NO INTERVENTION

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

ACTIVE COMPARATOR

Sleep Hygiene Education: Participants are provided a Sleep Hygiene Education Brochure containing information about getting a "good night's sleep."

Behavioral: Sleep Hygiene Education

Over-the-counter sleep aids (25 mg Benadryl + 3mg melatonin)

ACTIVE COMPARATOR

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."

Drug: Diphenhydramine (Benadryl); Dietary Supplement: Melatonin; Behavioral: Sleep Hygiene Education

Interventions

Diphenhydramine (Benadryl) DRUG

Oral Diphenhydramine (Benadryl), 25 mg

Over-the-counter sleep aids (25 mg Benadryl + 3mg melatonin)

Melatonin DIETARY_SUPPLEMENT

Oral Melatonin, 3 mg

Over-the-counter sleep aids (25 mg Benadryl + 3mg melatonin)

Sleep Hygiene Education BEHAVIORAL

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

Over-the-counter sleep aids (25 mg Benadryl + 3mg melatonin); Sleep Hygiene Education

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• All patients undergoing elective primary total hip or knee arthroplasty

You may not qualify if:

• History of substance abuse
• Workman's compensation patients
• Revision joint replacement
• History of prescription or over-the- counter sleep aid use

Sponsors & Collaborators

• James A. Keeney: lead

Study Sites (1)

Vicki L Jones

Columbia, Missouri, 65212, United States

Location

MeSH Terms

Interventions

Diphenhydramine; Melatonin

Intervention Hierarchy (Ancestors)

Ethylamines; Amines; Organic Chemicals; Benzhydryl Compounds; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Tryptamines; Indoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists

Results Point of Contact

• Title: Vicki L Jones
• Organization: UMissouri - Missouri Orthopaedic Institute

jonesvicki@health.missouri.edu

573-882-7583

Publication Agreements

• PI is Sponsor Employee: Yes
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Masking Details: 1. Benadryl + Melatonin Group + Sleep Hygiene Education 2. Sleep Hygiene Education Group 3. Control group (Usual Care)
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Chief Adult Hip and Knee Reconstruction Service, Department of Orthopaedic Surgery, University of Missouri

Study Record Dates

• First Submitted: May 23, 2019
• First Posted: May 30, 2019
• Study Start: October 1, 2019
• Primary Completion: March 1, 2022
• Study Completion: May 22, 2022
• Last Updated: July 16, 2024
• Results First Posted: July 16, 2024

Record last verified: 2024-06

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)