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

NCT ID: NCT04774965

Last Updated: 2025-03-19

Basic Information

• Recruitment Status: WITHDRAWN
• Clinical Phase: NA
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-06-30
• Study Completion Date: 2024-06-24

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.

Conditions

Rotator Cuff Tears; Surgery; Pain, Postoperative

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: NONE

Study Groups

Slumber Curve Group

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

Group Type: EXPERIMENTAL

Slumber Curve sleep aid

Intervention Type: 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.

Normal Sleep Routine Group

Patients not receiving sleep aid.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

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.

Intervention Type: DEVICE

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 99 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Eight28, LLC

UNKNOWN

Sponsor Role: collaborator

University of Alabama at Birmingham

OTHER

Sponsor Role: lead

Responsible Party

Amit Momaya

Assistant Professor, Section Chief, Sports Medicine

Responsibility Role: PRINCIPAL_INVESTIGATOR

References

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.

Reference Type: BACKGROUND

PMID: 33447619 (View on PubMed)

Other Identifiers

IRB-300006834

Identifier Type: -

Identifier Source: org_study_id