Sleep Disturbance Clinical Trial
Official title:
Randomized Trial Investigating Melatonin Supplementation vs Placebo on Sleep Disturbance Following Total Joint Arthroplasty
Verified date | October 2020 |
Source | Rothman Institute Orthopaedics |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
The purpose of this study is to determine whether melatonin when used as a supplement after surgery improves sleep following total joint arthroplasty
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 |
Country | Name | City | State |
---|---|---|---|
United States | Rothman Orthopaedic Institute | Philadelphia | Pennsylvania |
Lead Sponsor | Collaborator |
---|---|
Rothman Institute Orthopaedics |
United States,
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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