NCT04590742

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

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
154

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Feb 2018

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 27, 2018

Completed
2.6 years until next milestone

First Submitted

Initial submission to the registry

October 12, 2020

Completed
7 days until next milestone

First Posted

Study publicly available on registry

October 19, 2020

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 30, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 30, 2021

Completed
Last Updated

October 19, 2020

Status Verified

October 1, 2020

Enrollment Period

3.8 years

First QC Date

October 12, 2020

Last Update Submit

October 15, 2020

Conditions

Sleep DisturbanceTotal Joint Arthroplasty

Outcome Measures

Primary Outcomes (1)

  • Patient Sleep Quality

    Patients quality of sleep will be analyzed by having them answer a sleep quality index (PSQI) questionnaires

    6 weeks

Study Arms (2)

Group 1

PLACEBO COMPARATOR

Placebo Tablet

Drug: Placebo

Group 2

ACTIVE COMPARATOR

Melatonin (6mg)

Drug: melatonin 6mg

Interventions

melatonin 6mgDRUG

6 weeks of melatonin (6mg) given to patient

Group 2
PlaceboDRUG

Patient given 6 weeks of placebo tablet

Group 1

Eligibility Criteria

Age18 Years - 99 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patients who undergo unilateral primary total joint arthroplasty
  • Patient willing and able to complete postoperative surveys

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Rothman Orthopaedic Institute

Philadelphia, Pennsylvania, 19107, United States

Location

MeSH Terms

Conditions

Parasomnias

Interventions

Melatonin

Condition Hierarchy (Ancestors)

Sleep Wake DisordersNervous System DiseasesMental Disorders

Intervention Hierarchy (Ancestors)

TryptaminesIndolesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingHeterocyclic CompoundsHormonesHormones, Hormone Substitutes, and Hormone Antagonists

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 12, 2020

First Posted

October 19, 2020

Study Start

February 27, 2018

Primary Completion

November 30, 2021

Study Completion

November 30, 2021

Last Updated

October 19, 2020

Record last verified: 2020-10

Locations

US(1)