Ongoing, recruitingTherapeutic exploratory (Phase II)Interventional

A double blind, placebo controlled, parallel, study to evaluate the effects of NAL in Obstructive Sleep Apnea Patients.

This study is investigating a new treatment, NACYSTELYN, for adults who suffer from 'Obstructive Sleep Apnoea'. This condition causes breathing to repeatedly stop and start during sleep. The study is designed to compare NACYSTELYN with a 'dummy' pill (placebo) to see if the new medicine can improve sleep apnoea over six weeks. Researchers will measure how often breathing stops or becomes very shallow during sleep, and will also look at other factors like snoring, how sleepy people feel during the day, and their general quality of life. The aim is to find out if NACYSTELYN could be a safe and effective way to help manage sleep apnoea symptoms.

At a glance

Status

Ongoing, recruiting

Phase

Therapeutic exploratory (Phase II)

Sponsor

Laboratoires S.M.B.

Enrolment target

Start

21 May 2024

Obstructive Sleep Apnea

What is this study about?

This research study is about a condition called Obstructive Sleep Apnoea. If you have this condition, your breathing repeatedly stops and starts while you're asleep. This can lead to very broken sleep, feeling tired during the day, and other health issues.

The study is testing a new medicine called NACYSTELYN to see if it can help people with Obstructive Sleep Apnoea. To do this, some participants will receive the new medicine, while others will receive a 'placebo' – which looks like the medicine but doesn't contain any active ingredients. This is a common way to test new treatments fairly, as neither you nor your doctor will know whether you are taking the medicine or the placebo during the study. This helps researchers get clear results about the medicine's true effects.

The main goal of the study is to measure how much the new medicine can reduce the number of breathing stops and shallow breaths you have during the night over a six-week period. They will also look at other things that affect your sleep and health, like how much you snore, your energy levels, and your general feelings of well-being, to get a full picture of how the medicine might help.

Key takeaways

Tests a new medicine, NACYSTELYN, for Obstructive Sleep Apnoea.
Compares the new medicine to a dummy pill (placebo) over 6 weeks.
Aims to reduce breathing problems during sleep.
Involves regular health checks and sleep assessments.
Open to adults aged 18 and over with sleep apnoea.

Who may be eligible?

To join this study, you need to be an adult, 18 years or older. The study is open to both men and women.

You would need to have a diagnosis of Obstructive Sleep Apnoea. The researchers will have specific criteria that define how severe your sleep apnoea needs to be to join the study.

There may be other health conditions or medications that could prevent you from taking part, to make sure the study is safe for you and the results are clear. Your doctor or the study team would go through these with you in detail.

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?
Do you have a diagnosis of Obstructive Sleep Apnoea?
Are you able to attend study visits and complete required assessments?
Are you willing to take study medication (or placebo) for six weeks?

Answer every question to see your result.

What does participation involve?

If you decide to take part, you would be given either the new medicine (NACYSTELYN) or a dummy pill (placebo).

Over the six-week study period, you would have several visits or assessments. These would likely include tests to measure your breathing during sleep, similar to the type you might have had when diagnosed with sleep apnoea. You would also be asked to complete questionnaires about your sleepiness, energy levels, and general health.

Researchers will also check your general health through physical examinations, blood tests, and by monitoring any side effects you might experience. After the six weeks of treatment, there would be a final assessment. The total duration of your active involvement in the study would be around six weeks, plus any initial screening and follow-up checks.

Potential risks and benefits

Taking part in a study like this could potentially offer benefits, such as access to a new treatment before it's widely available, and close monitoring of your health. However, there's no guarantee that the treatment will help you, as some participants will receive a placebo. Like all medicines, NACYSTELYN might also cause side effects, which the study team would discuss with you. You are free to withdraw from the study at any time, for any reason, without it affecting your usual medical care.

Locations (2)

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

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Unverified
France
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Unverified
Belgium

Common questions

What is Obstructive Sleep Apnoea?

It's a condition where your breathing repeatedly stops and starts while you're asleep, often due to a blockage in your airway.

What is a 'placebo'?

A placebo is a dummy pill that looks like the real medicine but doesn't contain any active ingredients. It's used to compare against the new medicine.

How long will I be in the study?

Your active participation in the study, including receiving the treatment, will last for about six weeks.

Will I know if I'm getting the real medicine?

No, this is a 'blind' study, meaning neither you nor the study doctors will know whether you are receiving NACYSTELYN or the placebo until after the study ends.

What kind of tests will I have?

You'll likely have sleep tests to check your breathing, complete questionnaires about your sleep and health, and have general health checks.