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

NCT04774965 · Status: WITHDRAWN · Phase: NA · Type: INTERVENTIONAL

Last updated 2025-03-19

No results posted yet for this study

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

Interventions

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.

Sponsors & Collaborators

  • Eight28, LLC

    collaborator UNKNOWN

  • University of Alabama at Birmingham

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
99 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-06-30
Primary Completion
2024-06-24
Completion
2024-06-24
FDA Device
Yes

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04774965 on ClinicalTrials.gov