Sleep Disturbance
Conditions
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.
Interventions
DIETARY_SUPPLEMENTmelatonin
Melatonin capsules to be taken for 6 weeks
Sponsors
Rothman Institute Orthopaedics
Study design
Allocation
NON_RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Masking description
This is a provider-crossover study design: subjects will receive treatment according to their provider's standard of care
Intervention model description
This is a provider-crossover study design.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Pittsburg Sleep Quality Index (PSQI) | 6 weeks post-surgery | PSQI is a validated outcome measure for sleep quality |
Countries
United States
Outcome results
None listed