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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 : Unknown
Verified February 2020 by Rothman Institute Orthopaedics.
Recruitment status was:  Enrolling by invitation
First Posted : February 20, 2020
Last Update Posted : February 20, 2020
Sponsor:
Information provided by (Responsible Party):
Rothman Institute Orthopaedics

Tracking Information
First Submitted Date  ICMJE February 18, 2020
First Posted Date  ICMJE February 20, 2020
Last Update Posted Date February 20, 2020
Estimated Study Start Date  ICMJE March 2020
Estimated Primary Completion Date January 2021   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: February 18, 2020)
Pittsburg Sleep Quality Index (PSQI) [ Time Frame: 6 weeks post-surgery ]
PSQI is a validated outcome measure for sleep quality
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Sleep Quality and Pain Medication Use Following Arthroscopic Rotator Cuff Repair
Official Title  ICMJE Sleep Quality and Pain Medication Use Following Arthroscopic Rotator Cuff Repair
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE 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
Condition  ICMJE Sleep Disturbance
Intervention  ICMJE Dietary Supplement: melatonin
Melatonin capsules to be taken for 6 weeks
Study Arms  ICMJE
  • Active Comparator: Melatonin supplementation
    5mg melatonin tablets to be taken for 6 weeks
    Intervention: Dietary Supplement: melatonin
  • No Intervention: No supplementation
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Unknown status
Estimated Enrollment  ICMJE
 (submitted: February 18, 2020)
80
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE March 2021
Estimated Primary Completion Date January 2021   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT04278677
Other Study ID Numbers  ICMJE 2020 TJ 02
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE Not Provided
Current Responsible Party Rothman Institute Orthopaedics
Original Responsible Party Same as current
Current Study Sponsor  ICMJE Rothman Institute Orthopaedics
Original Study Sponsor  ICMJE Same as current
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account Rothman Institute Orthopaedics
Verification Date February 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP