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Ongoing, recruitingTherapeutic exploratory (Phase II)Interventional

Effect of Modafinil on military observational performance and residual capacity of the Dutch Air Assault Brigade: a field trial

This study was like a real-life test for a medicine called modafinil. It involved healthy soldiers from the Dutch Air Assault Brigade. The main aim was to see how modafinil affected their ability to stay alert and pay attention while doing their military tasks. Researchers wanted to find out if taking modafinil could help them perform better and for longer without getting tired, especially in demanding situations. This type of research helps us understand if certain medicines could be useful for people who need to stay focused for long periods, but it's an early stage of investigation.

At a glance

Status
Ongoing, recruiting
Phase
Therapeutic exploratory (Phase II)
Sponsor
TNO Netherlands Organisation for applied scientific research
Enrolment target
40
Start
26 Aug 2024

What is this study about?

This study explored how a medicine called modafinil might affect healthy people, specifically soldiers, when they need to stay alert and focused for extended periods. Think of it like a test to see if a medication could help someone keep their concentration and perform well, even when they're tired or under pressure. The researchers wanted to measure if modafinil could improve how well these soldiers could observe things and do their jobs effectively over time.

The trial was conducted in a real-world setting, meaning the soldiers were likely doing their usual duties while involved in the study. This helps researchers understand how the medicine works in everyday situations rather than just in a lab. It's important to remember that this was an early-stage study, often called a 'Phase II' trial, which means researchers are still exploring how the medicine works and if it has potential benefits. They are not yet recommending it for widespread use.

The findings from this kind of research can be important for understanding how to help people who need to perform complex tasks when they are tired or under stress. It contributes to our knowledge about how different substances might affect human performance and mental alertness, particularly in demanding roles.

Key takeaways

  • Looked at how modafinil affected alertness in healthy soldiers.
  • Aimed to see if it improved focus and performance during duties.
  • This was an early-stage study (Phase II) exploring its effects.
  • Involved healthy adults, both men and women, aged 18 and over.
  • Research helps understand how medicines affect performance in demanding jobs.

Who may be eligible?

To be part of this study, you needed to be an adult, 18 years old or older. There was no upper age limit, so older adults could also take part.

Both men and women were able to join this study. The researchers included healthy people, meaning participants generally didn't have any major ongoing health problems.

Because this was a study involving soldiers, it's likely that participants were active members of the military. However, the main health requirement was simply being a healthy adult.

Quick self-check
  • Are you 18 years old or older?
  • Are you generally in good health?
  • Are you male or female?
  • Are you willing to potentially take a study medication?

This is a guide only — the research team will confirm whether you can take part.

What does participation involve?

The details of what taking part involved aren't fully described, but generally in similar studies, you might: * Have some initial health checks to make sure you are healthy enough to join. * Potentially take the study medication (modafinil) or a dummy pill (placebo) according to a schedule. * Perform specific tasks or activities, which in this case related to military duties and observation. * Have your performance and alertness measured at different times. * Attend follow-up appointments to check on your health and any effects of the medication. The total duration of participation and the number of visits are not specified, but such studies can range from a few days to several weeks.

Potential risks and benefits

Participating in research can sometimes offer a potential benefit of accessing new treatments or contributing to medical knowledge. However, as this was an early-stage study, there's no guarantee of direct personal benefit. There could be potential risks or side effects from taking modafinil, which would have been explained in detail to participants before they joined. These might include headaches, nausea, or trouble sleeping. All participants would have been carefully monitored, and you always have the right to withdraw from a study at any time, for any reason, without it affecting your medical care.

Locations (1)

  • Netherlands

Common questions

What is modafinil?

Modafinil is a medicine that can help people stay awake and alert. It's sometimes used for sleep disorders, but in this study, it was being explored for its effects on healthy people.

Why did they study soldiers?

Soldiers often need to stay alert and focused for long periods in challenging situations, making them a useful group to study how a medicine might affect performance and watchfulness.

Was this a new medicine?

No, modafinil exists, but this study was exploring its effects in a specific group and context, which is common in early research stages.

What is a 'Phase II' study?

A Phase II study is an early stage of clinical research where scientists are exploring if a medicine works, what the right dose might be, and if it's safe for a particular use.

Will this medicine be given to everyone who needs to stay alert?

Not necessarily. This was an exploratory study. More research would be needed to understand if it's broadly useful and safe for different groups of people.

How to find out more

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

Discussion

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