AuthorisedTherapeutic use (Phase IV)Interventional

TheRapeutic StrAtegies for Obstructive SleeP Apnea in Older Adults with OverweigHt or Obesity: A RandomizEd Clinical TriaL (RAPHAEL study)

The RAPHAEL study is researching a new way to treat obstructive sleep apnea in older adults who are also overweight or obese. Obstructive sleep apnea is a common condition where breathing repeatedly stops and starts during sleep. The study is using a medication called Wegovy, given as an injection. Researchers want to find out if taking Wegovy for six months can reduce how often people stop breathing during sleep. They will also look at other things like how sleepy people feel during the day, their blood pressure, quality of life, and body weight. The aim is to see if Wegovy is a safe and effective treatment option for this group of people.

At a glance

Status

Authorised

Phase

Therapeutic use (Phase IV)

Sponsor

Institut De Recerca Biomedica De Lleida Fundacio Dr. Pifarre

Enrolment target

345

Start

30 Mar 2026

obstructive sleep apnea

What is this study about?

This study, called RAPHAEL, is all about finding better ways to help older adults who have a common sleep problem called obstructive sleep apnea, especially if they are also overweight or obese. Obstructive sleep apnea means that your breathing stops and starts many times while you're asleep. This can make you very tired during the day and can sometimes affect your health in other ways.

The researchers want to see if a medicine called Wegovy can help. Wegovy is given as an injection, and it's already used for weight management. In this study, they're hoping it might also help reduce the number of times people stop breathing during the night. They will be watching closely to see how participants' breathing changes after taking the medicine for six months.

Besides looking at breathing, the study will also check other important things. This includes how sleepy people feel, their blood pressure, how well they sleep, their mood, and their overall quality of life. They will also measure body weight and look at certain things in the blood that can tell us about inflammation and heart health. The goal is to understand all the ways Wegovy might help people with sleep apnea and whether it's a good and sensible treatment choice.

Key takeaways

The RAPHAEL study is exploring a new treatment for sleep apnea.
It focuses on older adults who are overweight or obese.
The study tests a medicine called Wegovy, given as an injection.
The main goal is to see if Wegovy reduces breathing interruptions during sleep.
Participation involves taking medication and regular clinic visits over six months.

Who may be eligible?

The RAPHAEL study is looking for both men and women of all adult ages. You will need to have a diagnosis of obstructive sleep apnea and also be considered overweight or obese to take part.

More specific details about your health and medical history would be checked by the study team to make sure it's safe for you to join. For example, they would need to ensure you don't have certain other health conditions or are taking medications that might interfere with the study medicine.

If you are interested in potentially joining, the study team would talk you through all the requirements in detail to see if the study is a good fit for you.

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 an adult of any age?
Have you been diagnosed with obstructive sleep apnea?
Are you considered overweight or obese?
Are you willing and able to attend regular clinic visits?

Answer every question to see your result.

What does participation involve?

If you decide to take part in this study, you would receive the study medication, Wegovy, which is given as an injection, over a period of six months. You would learn how to give yourself these injections or have someone help you. Throughout the study, you would have several visits to the clinic where the study team would check on your health and progress.

During these visits, you might have tests to measure your breathing during sleep, check your blood pressure, and take blood samples. You would also be asked to fill out questionnaires about how you are feeling, your sleep quality, and your general well-being. These assessments help the researchers understand if the medicine is working and how it affects different aspects of your health. The total duration of your active participation in the study, including follow-up, would last for six months.

Potential risks and benefits

Taking part in a study like this could offer potential benefits, such as receiving a new treatment that might improve your sleep apnea and overall health, and having close medical monitoring. However, there are also potential risks; for example, the study medicine Wegovy can have side effects, which the study team would fully explain to you. There's also no guarantee that the treatment will work for everyone, or that you will personally benefit. You have the right to withdraw from the study at any time, for any reason, without it affecting your usual medical care.

Locations (1)

Some site locations are approximate. We're improving this — please verify with the trial team before travelling.

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Unverified
Spain

Common questions

What is obstructive sleep apnea?

It's a condition where your breathing repeatedly stops and starts while you're asleep, often because your airway becomes temporarily blocked.

What is Wegovy?

Wegovy is a medicine that helps with weight management, and in this study, researchers are seeing if it can also help with sleep apnea.

How is Wegovy given?

It's given as an injection, using a pre-filled pen, which you would learn to use yourself or with help.

How long does the study last?

Your active participation in the study, including taking the medicine, would last for six months.

Will I know if I'm getting the medicine or a dummy treatment?

This study is a randomised trial, which means some people will get the active medicine and others might get a placebo (a dummy treatment). You usually won't know which one you are receiving.