Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04590742
Recruitment Status : Enrolling by invitation
First Posted : October 19, 2020
Last Update Posted : October 19, 2020
Sponsor:
Information provided by (Responsible Party):
Rothman Institute Orthopaedics

Brief Summary:
The purpose of this study is to determine whether melatonin when used as a supplement after surgery improves sleep following total joint arthroplasty

Condition or disease Intervention/treatment Phase
Sleep Disturbance Total Joint Arthroplasty Drug: melatonin 6mg Drug: Placebo Not Applicable

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 154 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Randomized Trial Investigating Melatonin Supplementation vs Placebo on Sleep Disturbance Following Total Joint Arthroplasty
Actual Study Start Date : February 27, 2018
Estimated Primary Completion Date : November 30, 2021
Estimated Study Completion Date : November 30, 2021

Resource links provided by the National Library of Medicine

Drug Information available for: Melatonin

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




Primary Outcome Measures :
  1. Patient Sleep Quality [ Time Frame: 6 weeks ]
    Patients quality of sleep will be analyzed by having them answer a sleep quality index (PSQI) questionnaires



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years to 99 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04590742


Locations
Layout table for location information
United States, Pennsylvania
Rothman Orthopaedic Institute
Philadelphia, Pennsylvania, United States, 19107
Sponsors and Collaborators
Rothman Institute Orthopaedics
Layout table for additonal information
Responsible Party: Rothman Institute Orthopaedics
ClinicalTrials.gov Identifier: NCT04590742    
Other Study ID Numbers: JJP17D.511
First Posted: October 19, 2020    Key Record Dates
Last Update Posted: October 19, 2020
Last Verified: October 2020

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
Layout table for MeSH terms
Dyssomnias
Parasomnias
Sleep Wake Disorders
Nervous System Diseases
Mental Disorders
Melatonin
Antioxidants
Molecular Mechanisms of Pharmacological Action
Protective Agents
Physiological Effects of Drugs
Central Nervous System Depressants