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

Surgery Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT04774965
• Other study ID #: IRB-300006834
• Status: Not yet recruiting
• Phase: N/A
• Start date: June 30, 2024
• Est. completion date: February 1, 2027

Study information

• Verified date: July 2023
• Source: University of Alabama at Birmingham
• Contact: Kyle D Paul, BS
• Phone: 2053329804
• Email: kylepaul[@]uab.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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 information / eligibility

• Status: Not yet recruiting
• Enrollment: 50
• Est. completion date: February 1, 2027
• Est. primary completion date: December 31, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 99 Years

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

Related Conditions & MeSH terms

• Pain, Postoperative
• Rotator Cuff Injuries
• Rotator Cuff Tears
• Surgery

Intervention

Device:
• Slumber Curve sleep aid
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.

Locations

Country	Name	City	State
United States	UAB Hospital Highlands	Birmingham	Alabama

Sponsors (2)

Lead Sponsor	Collaborator
University of Alabama at Birmingham	Eight28, LLC

Country where clinical trial is conducted

United States, 

References & Publications (1)

Kunze KN, Movasagghi K, Rossi DM, Polce EM, Cohn MR, Karhade AV, Chahla J. Systematic Review of Sleep Quality Before and After Arthroscopic Rotator Cuff Repair: Are Improvements Experienced and Maintained? Orthop J Sports Med. 2020 Dec 29;8(12):2325967120969224. doi: 10.1177/2325967120969224. eCollection 2020 Dec. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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
Primary	Visual Analog Scale (VAS)	Pain score, 0-10, 10 is best outcome	90 days
Primary	Single Assessment Numeric Evaluation (SANE)	Function score, 0-100%, 100% is best outcome	90 days
Primary	Postoperative Oral Morphine Equivalents	Oral morphine equivalents of all opioid-containing medications received	90 days
Primary	Simple Shoulder Test (SST)	Function score. Higher score indicates greater function.	90 days