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

Sleep Disturbance Clinical Trial

Official title:

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

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT04590742
• Other study ID #: JJP17D.511
• Status: Enrolling by invitation
• Phase: N/A
• 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
• 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

Related Conditions & MeSH terms

• Dyssomnias
• Parasomnias
• Sleep Disturbance
• Total Joint Arthroplasty

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