The Effect of a Custom Pillow on Sleep Quality in Patients With Nonoperative Rotator Cuff Syndrome

NCT05011331 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 80

Last updated 2025-04-29

No results posted yet for this study

Summary

The objective of this study is to determine if a pillow sleep aid improves sleep quality in the short term for patients who have shoulder pain from a rotator cuff injury and are being managed non-operatively.

Conditions

  • Rotator Cuff Injuries

Interventions

DEVICE

MedCline Shoulder Relief System

Patients will receive a customized pillow to aid with sleep

Sponsors & Collaborators

  • Amenity Health, Inc.

    collaborator INDUSTRY
  • Rhode Island Hospital

    lead OTHER

Principal Investigators

  • E S Paxton, MD · University Orthopedics

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-10-13
Primary Completion
2026-12-31
Completion
2027-12-31
FDA Device
Yes

Countries

  • United States

Study Locations

More Related Trials

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 NCT05011331 on ClinicalTrials.gov