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AuthorisedTherapeutic use (Phase IV)Interventional

Sleep structure in neuropathic pain patients, psychological factors, brain connectivity, and the effect of pregabalin on sleep and pain

This study is investigating how a medicine called pregabalin works for people who have long-lasting nerve pain. Researchers want to understand if this medicine helps reduce pain and if it improves sleep. They will look closely at how pregabalin affects different stages of sleep. The study will also explore the connection between sleep problems, how the brain is wired, and a small part of the brain called the choroid plexus. Additionally, scientists will check if pregabalin changes people's natural daily body rhythms and their temperature while they sleep. This research aims to provide more information on how pain and sleep are linked and how pregabalin might help.

At a glance

Status
Authorised
Phase
Therapeutic use (Phase IV)
Sponsor
HUS-Yhtymae
Enrolment target
40
Start
14 Nov 2024

What is this study about?

This research study is looking into people who suffer from ongoing nerve pain. Nerve pain can be very uncomfortable and can often make it difficult to sleep. The main goal of this study is to see how a medicine called pregabalin affects both their pain levels and their sleep patterns. This isn't a new medicine; it's already used, and this study aims to learn more about its effects in a real-world setting.

The researchers want to find out if pregabalin really helps reduce pain, and they'll measure this using simple rating scales. But they also want to understand the bigger picture: how does pain affect sleep? And how does pregabalin change sleep? To do this, they'll use special equipment to monitor sleep stages overnight. They'll also use brain scans (fMRI) to see if there are links between sleep problems and how different parts of the brain communicate with each other. They're even looking at whether sleep issues are connected to the size of a tiny part of the brain called the choroid plexus.

Beyond pain and sleep changes, the study will explore other effects of pregabalin. They'll use devices worn on the wrist and special rings to track daily body rhythms over a week, checking if the medicine influences these natural cycles. They'll also measure body temperature during sleep. By bringing all this information together, the study hopes to give us a much clearer understanding of how pregabalin works, especially regarding the complex relationship between nerve pain and sleep.

Key takeaways

  • Study is about pregabalin's effects on nerve pain and sleep.
  • It will carefully measure pain levels and sleep patterns.
  • Brain scans will explore connections between sleep and brain activity.
  • Daily rhythms and body temperature during sleep will be monitored.
  • Aims to better understand how pain, sleep, and pregabalin are linked.
  • For adults aged 18 and over with persistent nerve pain.

Who may be eligible?

This study is looking for adults who are dealing with ongoing nerve pain. You need to be at least 18 years old.

Both men and women can take part in this research.

The most important thing is that you have persistent peripheral neuropathic pain, which is nerve pain that continues over time and affects your outer nerves, like those in your arms or legs.

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.

  1. Are you 18 years old or older?
  2. Do you have ongoing nerve pain (persistent peripheral neuropathic pain)?
  3. Are you able to take pregabalin medication?
  4. Are you willing to have your sleep monitored overnight?
  5. Are you comfortable with undergoing brain scans (fMRI)?
Answer every question to see your result.

What does participation involve?

If you decide to take part, you'll be given pregabalin capsules at different strengths (25mg, 75mg, or 150mg). The researchers will then carefully check how this medicine affects your pain using simple rating scales. You'll also have a special overnight stay where your sleep will be monitored using equipment to understand your sleep stages. You'll likely undergo brain scans (fMRI) to look at how your brain is working.

To understand your body's natural rhythms, you might wear a wrist device (actigraphy) and a special ring (OURA-ring) for about a week. There will also be a one-night measurement of your body temperature using a small device. The exact number of visits and the total time you'll be involved will be explained by the study team, but it will involve taking medication, undergoing various assessments, and follow-up checks.

Potential risks and benefits

Participating in this study might offer you the potential benefit of possibly improving your pain and sleep with pregabalin, and you'll be closely monitored by medical professionals. However, as with any medicine, there are potential risks, including side effects from pregabalin, which will be fully explained before you agree to take part. There may also be slight discomfort from wearing monitoring devices or lying still for scans. Your safety and well-being are paramount, and you are free to withdraw from the study at any time, for any reason, without it affecting your medical care.

Locations (1)

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

Common questions

What kind of pain is this study for?

This study is for people who have ongoing nerve pain, specifically called 'persistent peripheral neuropathic pain'.

What is pregabalin?

Pregabalin is a medicine that is already used to treat nerve pain and some other conditions. This study wants to learn more about how it works for pain and sleep.

Will I have to stay overnight anywhere?

Yes, you will have at least one overnight stay where your sleep will be carefully monitored using special equipment.

What are 'brain scans'?

Brain scans, also known as fMRI, are special tests that take pictures of your brain and show how different parts of it are working.

Do I have to take part if I'm asked?

No, taking part in any research study is completely voluntary. You can decide not to participate, or you can withdraw at any time.

How to find out more

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

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