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

The University of Alabama at Birmingham logo

The University of Alabama at Birmingham

Status

Withdrawn

Conditions

Surgery
Pain, Postoperative
Rotator Cuff Tears

Treatments

Device: Slumber Curve sleep aid

Study type

Interventional

Funder types

Other

Identifiers

NCT04774965
IRB-300006834

Details and patient eligibility

About

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.

Full 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.

Sex

All

Ages

18 to 99 years old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Supportive Care

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

0 participants in 2 patient groups

Slumber Curve Group
Experimental group
Description:
Patients receiving Slumber Curve sleep aid for management of pain and sleep quality following rotator cuff repair.
Treatment:
Device: Slumber Curve sleep aid
Normal Sleep Routine Group
No Intervention group
Description:
Patients not receiving sleep aid.

Trial contacts and locations

1

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Central trial contact

Kyle D Paul, BS

Data sourced from clinicaltrials.gov

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