Not yet recruitingNAINTERVENTIONAL

Pillow Brace Assessment on Sleep Quality of Patients Undergoing Arthroscopic Rotator Cuff Surgery

This study is investigating a new `Pillow Brace` designed to improve sleep quality for patients recovering from shoulder surgery for a rotator cuff injury. After this type of surgery, many people experience significant pain at night, which can make it hard to sleep. Current standard slings don't always help enough with this problem. The researchers believe this new brace, which includes a special support cushion, could reduce nighttime pain and lead to better sleep. This could help people recover faster and feel more satisfied with their care. The study aims to compare the `Pillow Brace` to standard slings to see if it makes a real difference.

At a glance

Status

Not yet recruiting

Phase

Sponsor

GCS Ramsay Santé pour l'Enseignement et la Recherche

Enrolment target

100

Start

01 Oct 2025

Estimated completion

31 Jul 2027

Rotator Cuff Injury

What is this study about?

When you have surgery on your shoulder for a rotator cuff injury, it's a common procedure to help you move your arm better and reduce pain. Surgeons use special techniques that have really improved how well people recover. However, one big challenge for patients is dealing with pain, especially at night. This pain can make it very difficult to get a good night's sleep, which then affects how quickly you heal and how happy you are with your recovery.

At the moment, the slings or braces usually given after surgery don't always do enough to help with this nighttime pain. This means there's a need for better ways to support patients during their recovery. This study is looking at a new type of brace, called the `Pillow Brace`, which has a built-in cushion system. The idea is that this cushion could help support your shoulder in a way that makes you more comfortable, particularly when you're trying to sleep.

The developers of this `Pillow Brace` hope it will make a big difference in reducing pain at night and therefore improving sleep quality. If it works, it could help people feel much more comfortable after surgery, speed up their recovery, and generally improve their quality of life. The study aims to see if this new brace really does help patients sleep better compared to the standard slings currently used.

Key takeaways

This study evaluates a new brace for shoulder surgery patients.
The `Pillow Brace` aims to improve sleep quality and reduce nighttime pain.
It's for people having first-time rotator cuff repair surgery.
The study compares the new brace to standard slings.
Better sleep could lead to a faster and more comfortable recovery.

Who may be eligible?

To take part in this study, you need to be an adult (18 years or older) who is having shoulder surgery to repair a rotator cuff injury. You should be able to understand the instructions for using the brace and be able to do your daily activities, even if you need some help. You also need to be part of a social security system and be able to speak French. Before joining, you will need to read and sign a consent form, showing you understand what the study involves.

You won't be able to join if your shoulder problem isn't definitely a rotator cuff injury, or if you're having another rotator cuff surgery because a previous one didn't work. People with broken bones in their shoulder, arm, or ribs, or those who’ve had many surgeries recently (in the last 6 months), can't take part. If you have severe arthritis or other shoulder problems not related to your rotator cuff, or if you're taking strong pain medication like long-term morphine, you also can't join. Pregnant women, anyone with allergies to brace materials, or those who are already in another research study are also unable to participate. The study also cannot include individuals under guardianship or similar legal protection.

Could this study suit you?

Answer these quick questions to see if you may be eligible. This is a guide only — the research team makes the final call.

Are you 18 years or older?
Are you having your first surgery for a rotator cuff injury now?
Can you understand instructions for using a brace?
Do you not have any other complex breaks or shoulder problems?
Are you not pregnant or already in another study?

Answer every question to see your result.

What does participation involve?

If you decide to take part in this study, you will be given either the new `Pillow Brace` or a standard sling after your shoulder surgery. You will use this brace/sling as instructed during your recovery. The study will involve regular check-ups to see how you are healing and to ask you about your pain levels and how well you are sleeping. There won't be any extra medications given as part of this study, as it focuses on the brace itself. The exact number of visits and the total duration of your involvement will be clearly explained to you before you agree to participate.

Potential risks and benefits

Taking part in this study may offer potential benefits, such as improved sleep and reduced nighttime pain if you receive the `Pillow Brace`. However, there's no guarantee it will work for everyone, and it might not be more effective than a standard sling. Potential risks are generally low, as the brace is for support, but it's always possible to experience discomfort or irritation from any medical device. You will be closely monitored for any issues. Remember, your participation is completely voluntary, and you have the right to withdraw from the study at any time, for any reason, without it affecting your medical care.

Locations (1)

Clinique Jouvenet
Verified postcode
Paris, France

Common questions

What is a rotator cuff injury?

It's when you damage the group of muscles and tendons that surround your shoulder joint, helping you lift and rotate your arm.

What is the 'Pillow Brace'?

It's a special type of brace that includes a supportive cushion, designed to help improve comfort and sleep quality after shoulder surgery.

Will I definitely get the 'Pillow Brace' if I join?

You might get the `Pillow Brace` or a standard sling. The study is comparing the two to see which works better.

Why is sleep so important after surgery?

Good sleep helps your body heal, reduces pain, and can make your recovery faster and more comfortable.

Can I leave the study if I change my mind?

Yes, you can choose to leave the study at any time without it affecting your medical care.

How to find out more

Philippe NGUYEN, MD

philippe.nguyen.pro@gmail.com +33 6 86 40 82 84 Official trial record

Always speak to your GP or specialist before deciding to take part in a study.