Ongoing, recruitingTherapeutic exploratory (Phase II)Interventional

Evaluation of the Effects of Neurexan® on Short-Term Insomnia, Daytime Performance and Stress Response by Polysomnography (PSG), Electroencephalogram (EEG), Stress Biomarkers and Patient-Reported Outcomes (PROs) An Exploratory, Placebo-Controlled Trial in Short-Term Insomnia Patients

This research is exploring a tablet called Neurexan to see if it helps people who are experiencing short-term insomnia, which means they're having difficulty sleeping for a short period. The main goal is to understand how Neurexan changes sleep efficiency, which is how well and long someone sleeps at night. Researchers will use special sleep tests called polysomnography (PSG) to measure this. They will also look at other aspects of sleep, how people feel and perform during the day, and their body's response to stress. This is a small, early-stage study to learn more about Neurexan compared to a dummy pill (placebo).

At a glance

Status

Ongoing, recruiting

Phase

Therapeutic exploratory (Phase II)

Sponsor

Biologische Heilmittel Heel GmbH

Enrolment target

Start

07 Aug 2024

Short-Term Insomnia

What is this study about?

Having trouble sleeping for a short time can be really frustrating and affect how you feel during the day. This study is exploring a tablet called Neurexan to see if it can help improve sleep for people who are experiencing what doctors call 'short-term insomnia'. This means you're having difficulty falling asleep or staying asleep for a period, but it's not a long-term problem.

The main thing the researchers want to find out is whether Neurexan helps you sleep better and more efficiently. They will measure your sleep very carefully using special equipment that records your brain waves and other body functions while you sleep – this is called polysomnography (PSG). This test gives a detailed picture of your sleep patterns.

Besides looking at how well you sleep, the study will also check other things. This includes how alert and well you function during the day, how your body responds to stressful situations, and what you notice about your own sleep and how you feel through questionnaires and diaries. By doing this, they hope to get a full picture of how Neurexan might affect people with short-term sleep difficulties.

Key takeaways

This study explores a tablet called Neurexan for short-term sleep difficulties.
It aims to see if Neurexan improves sleep patterns and daytime performance.
Special sleep tests (polysomnography) will be used to measure changes.
You might receive Neurexan or a dummy pill (placebo).
Participation includes visits, sleep monitoring, questionnaires, and possibly blood tests.

Who may be eligible?

To be considered for this study, you need to be at least 18 years old. There's no upper age limit, so older adults can also take part.

The study is open to both men and women. The most important thing is that you are currently experiencing short-term insomnia, meaning you’re having trouble sleeping for a short period of time.

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?
Are you currently having trouble sleeping for a short time (short-term insomnia)?
Are you able to attend study visits and undergo sleep tests?
Are you willing to keep a sleep diary and answer questions about your sleep?

Answer every question to see your result.

What does participation involve?

If you join this study, it's an 'exploratory' study, which means it's an early look into how Neurexan works. You would either receive the Neurexan tablet or a dummy pill (placebo), but you wouldn’t know which one you’re taking. This allows researchers to compare the effects accurately.

You would have a few visits to the study centre. During these visits, there will be special tests, including sleep studies where a machine checks your sleep patterns overnight. You might also have recordings of your brain activity during the day and have some blood samples taken to check stress levels. You will also be asked to keep a sleep diary and answer questions about your sleep and how you feel during the day. You would also wear a small device at home that tracks your activity and sleep patterns continuously. The total duration of your participation would involve these assessments and following up on how you're doing.

Potential risks and benefits

Taking part in a study like this may or may not directly help you, but the information gained could help others in the future. You might benefit from the close medical attention and detailed sleep monitoring. As with any medication, there could be side effects from Neurexan, though it's not yet clear what these might be. You'll be closely monitored for any changes. 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
Germany

Common questions

What is 'short-term insomnia'?

Short-term insomnia means you are having difficulty sleeping for a short period of time, usually less than three months.

What is polysomnography (PSG)?

PSG is a sleep study where doctors monitor your brain waves, breathing, heart rate, and other body functions while you sleep to understand your sleep patterns.

What is a placebo?

A placebo is a dummy pill that looks like the real medicine but contains no active ingredients. It helps researchers compare the true effects of the study drug.

Will I know if I'm taking Neurexan or the placebo?

No, this type of study is 'blinded,' meaning neither you nor the study team will know if you're taking Neurexan or the placebo until after the study is over.

What will happen with my personal information?

Your personal information will be kept private and confidential. Only the study team will have access to it, and your identity will not be shared in any study reports.