The Effects of SlumberCurve™ Following Rotator Cuff Surgery: A Randomized Control Trial

Study Overview
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Brief Summary
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The purpose of this study is to investigate the effects of a novel sleep aid known as SlumberCurve™, which serves as an adjustable form of a wedge pillow, on sleep quality and pain management following rotator cuff repair. The researchers hypothesize that SlumberCurve™ will significantly improve sleep quality and reduce night-time pain.

Detailed Description
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Poor sleep quality is prevalent among patients undergoing rotator cuff repair surgery, and negatively affects the potential for proper healing. Without adequate sleep, the production of anabolic steroids and inflammatory cytokines are diminished. These anabolic steroids and inflammatory cytokines play a key role in postoperative healing, resulting in adequate pain regulation and increased patient satisfaction. Therefore adequate sleep quality is important not only for quality of life, but for postoperative healing. A recent systematic review revealed that some studies reported varying degrees in both the time and magnitude of change in return to adequate sleep quality following rotator cuff repair. This study hopes to address this gap in the literature by investigating a novel sleep aid, SlumberCurve, and its effect on sleep quality and night-time pain relief. SlumberCurve is a Class I Medical Device and is currently advocated to relieve tension and diminish pain in patients undergoing rotator cuff repair surgery. The device provides adjustable elevation of the torso as well as concave positioning, placing the shoulder in a more forward position. This novel sleep aid has the potential to increase sleep quality, and therefore enhance both patient satisfaction and postoperative recovery from rotator cuff repair surgery.

Official Title
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The Effects of SlumberCurve™ Following Rotator Cuff Surgery: A Randomized Control Trial

Conditions
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Rotator Cuff Tears, Surgery, Pain, Postoperative

Intervention / Treatment
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* Device: Slumber Curve sleep aid


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: • Any male or nonpregnant female aged 18 years or older with a full-thickness rotator cuff tear undergoing rotator cuff repair surgery Exclusion Criteria: Patients who receive workers' compensation benefits Patients with irreparable tears Patients undergoing revision surgery Patients with concomitant severe glenohumeral arthritis or concurrent adhesive capsulitis Sleep apnea disorder or other diagnosed sleep disorder Neuropsychiatric disease Use of sleep medication Prior shoulder surgery Rotator cuff arthropathy with pseudo paralysis Acute fractures involving the proximal humerus or shoulder girdle

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 99 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Slumber Curve Group<br>Patients receiving Slumber Curve sleep aid for management of pain and sleep quality following rotator cuff repair. | Device: Slumber Curve sleep aid<br>* Patients who undergo rotator cuff repair and have been consented and randomized to the experimental group will be given a Slumber Curve sleep aid to be used during sleep. Each device will be numbered and recorded in the patient's REDCap entry for future reference if needed. Following administration of the Slumber Curve, patients will be given instructions on how to use the sleep aid while sleeping, and will be asked to use Slumber Curve nightly.<br>|
| No Intervention: Normal Sleep Routine Group<br>Patients not receiving sleep aid. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Fitbit Sleep Data - Time spent awake, restless, and asleep | Estimates of time spent awake, restless, and asleep will be assessed. All three measures will be recorded in minutes. Restless sleep indicates movement, and excessive movement will indicates time spent awake. | 90 days | 
| Fitbit Sleep Data - Sleep Stages | Sleep stages are estimated by utilizing movement and heart rate variability. Sleep stages are categorized into light sleep, deep sleep, and REM. Collective time spent in each stage will be recorded in minutes. | 90 days | 
| Pittsburgh Sleep Quality Index (PSQI) | The PSQI tracks sleep disturbances over time and includes seven component scores: subjective sleep quality, sleep latency, sleep duration, habitual sleep efficiency, sleep disturbances, sleeping medications, and daytime dysfunction. Total of 21 points. Scores of less than 5 indicate adequate sleep. Scores of greater than 5 indicate poor sleep. | 90 days | 
| Visual Analog Scale (VAS) | Pain score, 0-10, 10 is best outcome | 90 days | 
| Single Assessment Numeric Evaluation (SANE) | Function score, 0-100%, 100% is best outcome | 90 days | 
| Postoperative Oral Morphine Equivalents | Oral morphine equivalents of all opioid-containing medications received | 90 days | 
| Simple Shoulder Test (SST) | Function score. Higher score indicates greater function. | 90 days |