NCT04278677

Brief Summary

The purpose of this study is to investigate if oral melatonin reduces postoperative sleep 18 disturbances and narcotics use. We will enroll patients undergoing primary arthroscopic rotator 19 cuff repair (ARCR) at the Rothman Institute.

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
80

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Mar 2020

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

First Submitted

Initial submission to the registry

February 18, 2020

Completed
2 days until next milestone

First Posted

Study publicly available on registry

February 20, 2020

Completed
10 days until next milestone

Study Start

First participant enrolled

March 1, 2020

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2021

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2021

Completed
Last Updated

February 20, 2020

Status Verified

February 1, 2020

Enrollment Period

10 months

First QC Date

February 18, 2020

Last Update Submit

February 18, 2020

Conditions

Sleep Disturbance

Outcome Measures

Primary Outcomes (1)

  • Pittsburg Sleep Quality Index (PSQI)

    PSQI is a validated outcome measure for sleep quality

    6 weeks post-surgery

Study Arms (2)

Melatonin supplementation

ACTIVE COMPARATOR

5mg melatonin tablets to be taken for 6 weeks

Dietary Supplement: melatonin

No supplementation

NO INTERVENTION

Interventions

melatoninDIETARY_SUPPLEMENT

Melatonin capsules to be taken for 6 weeks

Melatonin supplementation

Eligibility Criteria

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

You may qualify if:

  • Patients who undergo primary ARCR
  • Patient willing and able to complete postoperative surveys

You may not qualify if:

  • Daily melatonin use for \> 1 week during the last 3 months
  • Irreparable tears
  • Revision rotator cuff repairs
  • Severe glenohumeral arthritis
  • Concurrent adhesive capsulitis
  • Age less than 18
  • Pregnancy
  • History of substance abuse (drug or alcohol)
  • Workman's comp patient or patient has current litigation pending
  • Allergy to melatonin
  • History of delirium/psychiatric/depression/ on antidepressants
  • History of insomnia/ on sleep aid medication
  • Use of prescription sedatives
  • use of Zelboraf (vemurafenib)
  • Use of all blood thinning medications besides aspirin (warfarin, plavix, lovenox, etc.)
  • +1 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Rothman Orthopaedics at Egg Harbor Township

Egg Harbor, New Jersey, 08234, United States

Location

Related Publications (1)

  • Perez AR, Destine H, Patel NK, Campbell RE, Muchintala R, Hall AT, Pepe MD, Tucker BS, Tjoumakaris FP. Effects of Melatonin on Sleep Quality and Patient-Reported Outcomes After Arthroscopic Rotator Cuff Surgery: A Prospective Randomized Controlled Trial. Am J Sports Med. 2024 Oct;52(12):3075-3083. doi: 10.1177/03635465241272076. Epub 2024 Sep 15.

    PMID: 39279257DERIVED

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
NON RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Masking Details
This is a provider-crossover study design: subjects will receive treatment according to their provider's standard of care
Purpose
TREATMENT
Intervention Model
CROSSOVER
Model Details: This is a provider-crossover study design.
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 18, 2020

First Posted

February 20, 2020

Study Start

March 1, 2020

Primary Completion

January 1, 2021

Study Completion

March 1, 2021

Last Updated

February 20, 2020

Record last verified: 2020-02

Locations

US(1)