New pillow brace aims to give rotator cuff patients a better Night's sleep

NCT ID NCT07009379

Symptom relief Sponsor: GCS Ramsay Santé pour l'Enseignement et la Recherche Source: ClinicalTrials.gov ↗

First seen Jun 24, 2026 · Last updated Aug 21, 2026 · Updated 4 times

Summary

This study tests a special brace with a built-in pillow to see if it helps people sleep better after rotator cuff surgery. About 100 patients will either use the pillow brace or a standard brace. The goal is to reduce nighttime pain and improve sleep quality, which may help recovery.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance: Pillow Brace (a splint with a built-in cushion)
What this could lead to: If it works, this pillow brace could become a simple way to help people sleep better and recover more comfortably after rotator cuff surgery.
What could go wrong: This is a small, early-stage study with only 100 people. The brace is not yet CE-marked, and the results may not apply to everyone. It focuses on sleep, not on curing the injury.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

About 100 people

The number the study aims to enrol. It can still change while the study runs.

Started

Dec 2025

Expected to finish

Jul 2027

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: * Patient undergoing arthroscopic rotator cuff repair surgery confirmed by clinical diagnosis and preoperative imaging tests. * Patient able to understand the instructions for using the brace. * Patient able to perform activities of daily living with or without a brace, ensuring proper use of the brace. * Patient affiliated with or beneficiary of a social security system * French speaking patient, having signed an informed consent form Exclusion Criteria: * Patient with an uncertain diagnosis * Patient undergoing rotator cuff revision surgery. * Patient with complex or surgical fractures of the shoulder, humerus, or ribs * Patient with multiple fractures, open fractures, or those with pinning * Patient who has undergone multiple surgeries in the last 6 months. * Patient with shoulder pathologies unrelated to the rotator cuff, such as severe arthritis or capsulitis. * Patient on long-term morphine treatment * Patient with known allergies to splint materials * Protected patient: adult under guardianship, curatorship, or other legal protection, deprived of liberty by judicial or administrative order * Pregnant woman * Patient hospitalized without consent * Patient already enrolled and participating in another clinical study

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Conditions

The condition(s) this trial relates to.

Rotator Cuff Injuries rotator cuff syndrome

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Rotator cuff injury

How to take part

Only the study team decides who joins. These are the ways to reach them.

The places running it

1 site. The list below names each one and where it is.
The official record

ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

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A doctor treating you

A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

New pillow brace aims to give rotator cuff patients a better Night's sleep

What the study statuses mean