Randomized Trial Investigating Melatonin Supplementation vs Placebo on Sleep Disturbance Following Total Joint Arthroplasty

October 15, 2020 updated by: Rothman Institute Orthopaedics
The purpose of this study is to determine whether melatonin when used as a supplement after surgery improves sleep following total joint arthroplasty

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

154

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Pennsylvania
      • Philadelphia, Pennsylvania, United States, 19107
        • Rothman Orthopaedic Institute

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 99 years (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

  1. Patients who undergo unilateral primary total joint arthroplasty
  2. Patient willing and able to complete postoperative surveys

Exclusion Criteria:

  1. Patients who undergo revision total joint arthroplasty
  2. Patients who undergo bilateral total joint arthroplasty
  3. Patients currently taking melatonin supplementation
  4. Patient has history of substance abuse (drug or alcohol)
  5. Patient is a workman's comp patient or patient has current litigation pending
  6. Patient has an allergy to melatonin
  7. Patient has a history of delirium/psychiatric/depression/on antidepressants
  8. Patient has a history of insomnia/ on sleep aid medication
  9. Anyone on warfarin
  10. Sleep apnea
  11. Patient discharged to SNF or rehab
  12. Patients who have inflammatory conditions
  13. Shift work or night work

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: Group 1
Placebo Tablet
Drug: Placebo
Patient given 6 weeks of placebo tablet
Active Comparator: Group 2
Melatonin (6mg)
Drug: melatonin 6mg
6 weeks of melatonin (6mg) given to patient

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Patient Sleep Quality
Time Frame: 6 weeks
Patients quality of sleep will be analyzed by having them answer a sleep quality index (PSQI) questionnaires
6 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Rothman Institute Orthopaedics

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 27, 2018

Primary Completion (Anticipated)

November 30, 2021

Study Completion (Anticipated)

November 30, 2021

Study Registration Dates

First Submitted

October 12, 2020

First Submitted That Met QC Criteria

October 15, 2020

First Posted (Actual)

October 19, 2020

Study Record Updates

Last Update Posted (Actual)

October 19, 2020

Last Update Submitted That Met QC Criteria

October 15, 2020

Last Verified

October 1, 2020

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • JJP17D.511

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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