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Clinical Trial Details — Status: Enrolling by invitation

Administrative data

NCT number NCT04590742
Other study ID # JJP17D.511
Secondary ID
Status Enrolling by invitation
Phase N/A
First received
Last updated
Start date February 27, 2018
Est. completion date November 30, 2021

Study information

Verified date October 2020
Source Rothman Institute Orthopaedics
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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


Recruitment information / eligibility

Status Enrolling by invitation
Enrollment 154
Est. completion date November 30, 2021
Est. primary completion date November 30, 2021
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years to 99 Years
Eligibility 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 Design


Intervention

Drug:
melatonin 6mg
6 weeks of melatonin (6mg) given to patient
Placebo
Patient given 6 weeks of placebo tablet

Locations

Country Name City State
United States Rothman Orthopaedic Institute Philadelphia Pennsylvania

Sponsors (1)

Lead Sponsor Collaborator
Rothman Institute Orthopaedics

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Patient Sleep Quality Patients quality of sleep will be analyzed by having them answer a sleep quality index (PSQI) questionnaires 6 weeks
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