Back to resultsRandomized Trial Investigating Melatonin Supplementation vs Placebo on Sleep Disturbance Following Total Joint Arthroplasty
Primary Purpose
Sleep Disturbance, Total Joint Arthroplasty
Status
Unknown status
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
melatonin 6mg
Placebo
Sponsored by
About this trial
This is an interventional treatment trial for Sleep Disturbance
Eligibility Criteria
Inclusion Criteria:
- Patients who undergo unilateral primary total joint arthroplasty
- Patient willing and able to complete postoperative surveys
Exclusion Criteria:
- Patients who undergo revision total joint arthroplasty
- Patients who undergo bilateral total joint arthroplasty
- Patients currently taking melatonin supplementation
- Patient has history of substance abuse (drug or alcohol)
- Patient is a workman's comp patient or patient has current litigation pending
- Patient has an allergy to melatonin
- Patient has a history of delirium/psychiatric/depression/on antidepressants
- Patient has a history of insomnia/ on sleep aid medication
- Anyone on warfarin
- Sleep apnea
- Patient discharged to SNF or rehab
- Patients who have inflammatory conditions
- Shift work or night work
Sites / Locations
- Rothman Orthopaedic Institute
Arms of the Study
Arm 1
Arm 2
Arm Type
Placebo Comparator
Active Comparator
Arm Label
Group 1
Group 2
Arm Description
Placebo Tablet
Melatonin (6mg)
Outcomes
Primary Outcome Measures
Patient Sleep Quality
Patients quality of sleep will be analyzed by having them answer a sleep quality index (PSQI) questionnaires
Secondary Outcome Measures
Full Information
NCT ID
NCT04590742
First Posted
October 12, 2020
Last Updated
October 15, 2020
Sponsor
Rothman Institute Orthopaedics
1. Study Identification
Unique Protocol Identification Number
NCT04590742
Brief Title
Randomized Trial Investigating Melatonin Supplementation vs Placebo on Sleep Disturbance Following Total Joint Arthroplasty
Official Title
Randomized Trial Investigating Melatonin Supplementation vs Placebo on Sleep Disturbance Following Total Joint Arthroplasty
Study Type
Interventional
2. Study Status
Record Verification Date
October 2020
Overall Recruitment Status
Unknown status
Study Start Date
February 27, 2018 (Actual)
Primary Completion Date
November 30, 2021 (Anticipated)
Study Completion Date
November 30, 2021 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Rothman Institute Orthopaedics
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
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
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Sleep Disturbance, Total Joint Arthroplasty
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
154 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Group 1
Arm Type
Placebo Comparator
Arm Description
Placebo Tablet
Arm Title
Group 2
Arm Type
Active Comparator
Arm Description
Melatonin (6mg)
Intervention Type
Drug
Intervention Name(s)
melatonin 6mg
Intervention Description
6 weeks of melatonin (6mg) given to patient
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Patient given 6 weeks of placebo tablet
Primary Outcome Measure Information:
Title
Patient Sleep Quality
Description
Patients quality of sleep will be analyzed by having them answer a sleep quality index (PSQI) questionnaires
Time Frame
6 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
99 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
Patients who undergo unilateral primary total joint arthroplasty
Patient willing and able to complete postoperative surveys
Exclusion Criteria:
Patients who undergo revision total joint arthroplasty
Patients who undergo bilateral total joint arthroplasty
Patients currently taking melatonin supplementation
Patient has history of substance abuse (drug or alcohol)
Patient is a workman's comp patient or patient has current litigation pending
Patient has an allergy to melatonin
Patient has a history of delirium/psychiatric/depression/on antidepressants
Patient has a history of insomnia/ on sleep aid medication
Anyone on warfarin
Sleep apnea
Patient discharged to SNF or rehab
Patients who have inflammatory conditions
Shift work or night work
Facility Information:
Facility Name
Rothman Orthopaedic Institute
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19107
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Randomized Trial Investigating Melatonin Supplementation vs Placebo on Sleep Disturbance Following Total Joint Arthroplasty
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