RecruitingNAINTERVENTIONAL

Effect of Inspiratory Muscle Training in Obstructive Sleep Apnea Syndrome.

This study is investigating if a type of breathing exercise, called inspiratory muscle training, can help people with sleep apnea. Sleep apnea causes breathing to stop and start during sleep, leading to extreme tiredness during the day. While a machine called CPAP is the main treatment, many people find it hard to use consistently. Other exercises, like physical activity and jaw exercises, have shown promise. We're testing if strengthening the muscles you use to breathe in, like your diaphragm, can help keep your upper airway open and reduce daytime sleepiness. This could offer an additional way to manage sleep apnea alongside existing treatments.

At a glance

Status

Recruiting

Phase

Sponsor

Centre Hospitalier Régional d'Orléans

Enrolment target

Start

26 Jun 2024

Estimated completion

25 Jan 2027

Obstructive Sleep Apnea of Adult

What is this study about?

If you've been diagnosed with obstructive sleep apnea (OSA), you'll know it can be a really challenging condition. It means that while you're asleep, your breathing repeatedly stops and starts because your upper airway gets blocked or narrows. This often happens because the muscles around your throat relax too much, stopping air from getting into your lungs properly. The main problems people experience are feeling extremely tired during the day, which can really affect their daily life and enjoyment.

The usual treatment for sleep apnea is a machine called CPAP, which gently blows air into your nose and mouth to keep your airway open. While it works well for many, some people find it difficult to use consistently over a long period. This means doctors are always looking for other treatments or ways to support people with sleep apnea, perhaps to use alongside CPAP or for those who struggle with it.

We already know that other types of exercise, like general physical activity and exercises for the muscles in your mouth and throat, can be helpful for sleep apnea. This study is focusing on a less explored area: exercises specifically for the muscles you use to breathe in, like your diaphragm. The idea is that by making these breathing muscles stronger, they might help to keep your upper airway more open, reducing the breathing interruptions during sleep. Our main goal is to see if these breathing exercises can make a real difference in how tired you feel during the day.

Key takeaways

Tests a new breathing exercise for sleep apnea.
Aims to reduce daytime tiredness caused by sleep apnea.
Could offer an additional treatment option, especially for those finding CPAP difficult.
Focuses on strengthening 'breathing in' muscles.
Participation is voluntary and you can leave at any time.

Who may be eligible?

To be considered for this study, you need to be an adult, aged 18 or over, who has been diagnosed with obstructive sleep apnea (OSA). More specifically, your sleep apnea needs to be of a certain severity, measured by something called the Apnea Hypopnea Index (AHI) – typically meaning you have at least 5 breathing interruptions per hour during sleep – and your doctor must have recommended CPAP treatment for you, even if you find it hard to use.

There are some situations where you wouldn't be able to join. For example, if your sleep apnea is caused by a brain or nerve problem, or if you have certain health conditions that would make participating unsafe. We also can't include pregnant or breastfeeding women. Additionally, if you have issues with your memory or understanding, or if you're under legal guardianship, you wouldn't be eligible. Lastly, to take part, you need to be registered with a social security scheme, which is standard in the UK for NHS care.

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 old or older?
Have you been diagnosed with obstructive sleep apnea (OSA)?
Has your doctor recommended CPAP treatment for your sleep apnea?
Are you NOT pregnant or breastfeeding?
Do you NOT have sleep apnea caused by a brain or nerve problem?

Answer every question to see your result.

What does participation involve?

If you decide to take part in this study, you would primarily be focusing on a specific type of breathing exercise called inspiratory muscle training. This usually involves using a small device to help strengthen the muscles you use to breathe in. The study team would provide you with clear instructions on how to do these exercises, how often, and for how long. There would likely be initial visits for assessments and to learn how to use the equipment, and then follow-up sessions to check on your progress and make sure the exercises are being done correctly. These follow-up sessions might involve repeating some initial tests to see if your sleep apnea symptoms, especially daytime sleepiness, have improved. The total duration of your involvement in the study would be explained fully before you decide to take part.

Potential risks and benefits

Participating in this study might offer a potential benefit if the breathing exercises help reduce your daytime sleepiness and improve your quality of life, especially if you struggle with CPAP. It's generally considered a low-risk intervention, as the exercises are designed to strengthen natural breathing muscles, but as with any physical activity, there's a small chance of muscle fatigue or minor discomfort. There are no known serious dangers from this type of training for people with sleep apnea. Remember, joining any study is completely voluntary, and you are free to withdraw at any time without giving a reason, and this won't affect your future medical care.

Locations (1)

Chu Orleans
Verified postcode
Orléans, France· Recruiting

Common questions

What is 'inspiratory muscle training'?

It's a special type of exercise designed to strengthen the muscles you use to breathe in, especially your diaphragm, to help keep your airway open.

Will I have to stop using my CPAP machine if I join?

Not necessarily. This study is looking at these exercises as a potential additional therapy. The researchers will discuss your current treatment with you.

How long will the study last?

The full duration of your participation, including how long you'd do the exercises and have follow-up visits, would be explained by the study team.

What if I feel uncomfortable doing the exercises?

It's important to tell the study team immediately if you experience any discomfort. They can adjust the exercises or provide guidance.

Will I see a difference right away?

It's unlikely you'll see immediate changes. Muscle strengthening takes time, and the study will monitor progress over a period.

How to find out more

Aurelie DESPUJOLS, Msc

aurelie.despujols@chu-orleans.fr +332 38 74 40 71 Official trial record

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