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

NCT04774965 | Withdrawn FDA Device

• 1 other identifier: IRB-300006834
• Study Type: interventional
• Target: N/A
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Rotator Cuff Tears; Surgery; Pain, Postoperative

Outcome Measures

Primary Outcomes (7)

• 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

Study Arms (2)

Slumber Curve Group

EXPERIMENTAL

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

Device: Slumber Curve sleep aid

Normal Sleep Routine Group

NO INTERVENTION

Patients not receiving sleep aid.

Interventions

Slumber Curve sleep aid DEVICE

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.

Slumber Curve Group

Eligibility Criteria

• Age: 18 Years - 99 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Any male or nonpregnant female aged 18 years or older with a full-thickness rotator cuff tear undergoing rotator cuff repair surgery

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Alabama at Birmingham: lead
• Eight28, LLC: collaborator

Related 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.

  PMID: 33447619 BACKGROUND

MeSH Terms

Conditions

Rotator Cuff Injuries; Pain, Postoperative

Condition Hierarchy (Ancestors)

Rupture; Wounds and Injuries; Shoulder Injuries; Tendon Injuries; Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pain; Neurologic Manifestations; Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor, Section Chief, Sports Medicine

Study Record Dates

• First Submitted: February 24, 2021
• First Posted: March 1, 2021
• Study Start: June 30, 2023
• Primary Completion: June 24, 2024
• Study Completion: June 24, 2024
• Last Updated: March 19, 2025

Record last verified: 2025-03