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

Not Applicable

Withdrawn

Brief Summary: 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: 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.

Recruitment & Eligibility

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

Arm && Interventions

Group	Intervention	Description
Slumber Curve Group	Slumber Curve sleep aid	Patients receiving Slumber Curve sleep aid for management of pain and sleep quality following rotator cuff repair.

Primary Outcome Measures

Name	Time	Method
Fitbit Sleep Data - Time spent awake, restless, and asleep	90 days	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.
Postoperative Oral Morphine Equivalents	90 days	Oral morphine equivalents of all opioid-containing medications received
Simple Shoulder Test (SST)	90 days	Function score. Higher score indicates greater function.
Pittsburgh Sleep Quality Index (PSQI)	90 days	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.
Single Assessment Numeric Evaluation (SANE)	90 days	Function score, 0-100%, 100% is best outcome
Fitbit Sleep Data - Sleep Stages	90 days	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.
Visual Analog Scale (VAS)	90 days	Pain score, 0-10, 10 is best outcome

Secondary Outcome Measures

Name	Time	Method