Sleep Quality and Pain Medication Use Following Arthroscopic Rotator Cuff Repair

February 18, 2020 updated by: Rothman Institute Orthopaedics
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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

80

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • New Jersey
      • Egg Harbor Township, New Jersey, United States, 08234
        • Rothman Orthopaedics at Egg Harbor Township

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

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

Exclusion Criteria:

  • 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.)
  • Sleep apnea

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: NON_RANDOMIZED
  • Interventional Model: CROSSOVER
  • Masking: SINGLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
NO_INTERVENTION: No supplementation
ACTIVE_COMPARATOR: Melatonin supplementation
5mg melatonin tablets to be taken for 6 weeks
Dietary supplement: melatonin
Melatonin capsules to be taken for 6 weeks

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Pittsburg Sleep Quality Index (PSQI)
Time Frame: 6 weeks post-surgery
PSQI is a validated outcome measure for sleep quality
6 weeks post-surgery

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Rothman Institute Orthopaedics

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ANTICIPATED)

March 1, 2020

Primary Completion (ANTICIPATED)

January 1, 2021

Study Completion (ANTICIPATED)

March 1, 2021

Study Registration Dates

First Submitted

February 18, 2020

First Submitted That Met QC Criteria

February 18, 2020

First Posted (ACTUAL)

February 20, 2020

Study Record Updates

Last Update Posted (ACTUAL)

February 20, 2020

Last Update Submitted That Met QC Criteria

February 18, 2020

Last Verified

February 1, 2020

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2020 TJ 02

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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