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

Part of paid clinical trials in East Providence, Rhode Island.

Sponsor
Rhode Island Hospital
Study ID
NCT05011331
Status
Recruiting
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Conditions

  • Rotator Cuff Injuries

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • MedCline Shoulder Relief System — DEVICE
    Patients will receive a customized pillow to aid with sleep

Study Details

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.

Key Dates

Start date
Oct 13, 2020
Status verified
Apr 2025
Primary completion
Dec 31, 2026
Completion
Dec 31, 2027

Study Design

Enrollment
80 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: MedCline Shoulder Relief System
    Patients who will receive the MedCline Shoulder Relief System pillow
  • Active Comparator: Control
    Patients who will not receive the MedCline Shoulder Relief System pillow

Primary Outcome Measure

Change in Sleep Difficulty as Assessed as Assessed Using the Insomnia Severity Index (ISI) [ Time Frame: Baseline, two weeks, six weeks ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
University OrthopedicsEast ProvidenceRhode Island02915
Trevor Toavs
[email protected]
(401)443-4278

Find similar trials in East Providence, RI

By research site
University Orthopedics· East Providence, RI

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