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Sleep Quality and Pain Medication Use Following Arthroscopic Rotator Cuff Repair

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ClinicalTrials.gov Identifier: NCT04278677
Recruitment Status : Enrolling by invitation
First Posted : February 20, 2020
Last Update Posted : February 20, 2020
Sponsor:
Information provided by (Responsible Party):
Rothman Institute Orthopaedics

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.

Condition or disease Intervention/treatment Phase
Sleep Disturbance Dietary Supplement: melatonin Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 80 participants
Allocation: Non-Randomized
Intervention Model: Crossover Assignment
Intervention Model Description: This is a provider-crossover study design.
Masking: Single (Participant)
Masking Description: This is a provider-crossover study design: subjects will receive treatment according to their provider's standard of care
Primary Purpose: Treatment
Official Title: Sleep Quality and Pain Medication Use Following Arthroscopic Rotator Cuff Repair
Estimated Study Start Date : March 2020
Estimated Primary Completion Date : January 2021
Estimated Study Completion Date : March 2021

Resource links provided by the National Library of Medicine

Drug Information available for: Melatonin

Arm Intervention/treatment
Active Comparator: Melatonin supplementation
5mg melatonin tablets to be taken for 6 weeks
Dietary Supplement: melatonin
Melatonin capsules to be taken for 6 weeks

No Intervention: No supplementation



Primary Outcome Measures :
  1. Pittsburg Sleep Quality Index (PSQI) [ Time Frame: 6 weeks post-surgery ]
    PSQI is a validated outcome measure for sleep quality



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04278677


Locations
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United States, New Jersey
Rothman Orthopaedics at Egg Harbor Township
Egg Harbor Township, New Jersey, United States, 08234
Sponsors and Collaborators
Rothman Institute Orthopaedics
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Responsible Party: Rothman Institute Orthopaedics
ClinicalTrials.gov Identifier: NCT04278677    
Other Study ID Numbers: 2020 TJ 02
First Posted: February 20, 2020    Key Record Dates
Last Update Posted: February 20, 2020
Last Verified: February 2020

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Dyssomnias
Parasomnias
Sleep Wake Disorders
Nervous System Diseases
Mental Disorders
Melatonin
Antioxidants
Molecular Mechanisms of Pharmacological Action
Protective Agents
Physiological Effects of Drugs
Central Nervous System Depressants