Sleep Quality and Pain Medication Use Following Arthrosco... | NCT04278677

Studies
Sleep Quality and Pain Medication Use Following Arthroscopic Rotator Cuff Repair

NCT04278677

Sponsor

Rothman Institute Orthopaedics

Status

Unknown status

Last Update Posted

Feb 20, 2020Actual

Enrollment

80Estimated

Phase

Not Applicable

Conditions

Sleep Disturbance

Interventions

melatonin

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Feb 2020

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Enrolling by invitation

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Mar 2020Estimated

Primary Completion Date

Jan 2021Estimated

Completion Date

Mar 2021Estimated

First Submitted Date

Feb 18, 2020

First Submission Date that Met QC Criteria

Feb 18, 2020

First Posted Date

Feb 20, 2020Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Feb 18, 2020

Last Update Posted Date

Feb 20, 2020Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Not provided

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

80Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Melatonin supplementation	Active Comparator	5mg melatonin tablets to be taken for 6 weeks	Dietary Supplement: melatonin
No supplementation	No Intervention

Interventions

Name	Type	Description	Arm Group Labels	Other Names
melatonin	Dietary Supplement	Melatonin capsules to be taken for 6 weeks	Melatonin supplementation

Outcomes Module

Primary Outcomes

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

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility 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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Rothman Orthopaedics at Egg Harbor Township		Egg Harbor	New Jersey	08234	United States

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
39279257	Derived	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.

ID	Term
D012893	Sleep Wake Disorders
D009422	Nervous System Diseases
D001523	Mental Disorders

ID	Term
D014363	Tryptamines
D007211	Indoles
D006574	Heterocyclic Compounds, 2-Ring
D000072471	Heterocyclic Compounds, Fused-Ring