Insomnia Trial

Insomnia Trial

Protocol Number: AVE047-22

About this Clinical Study

How Clinical Trials Help People

This clinical study is testing an investigational capsule to see if it can help reduce the severity of long-term insomnia.

The study is for adults who have had ongoing sleep problems, such as:

  • Trouble falling asleep
  • Waking during the night and struggling to get back to sleep
  • Waking too early and feeling unrefreshed

How Clinical Trials Help People

The study is being run at selected clinics in Australia and includes both active treatment and placebo. Participants are randomly assigned to a group, and neither you nor the study team will know which treatment you receive during the study.

The aim is to understand whether the study treatment can improve sleep quality and daytime functioning when taken daily over several weeks.

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Who Can Take Part?

Who Can Take Part?

You may be able to take part if all of the following apply to you:

You are 18 years or older
You have had sleep problems for 3 months or longer
Your sleep problems occur at least 3 nights per week
Your sleep affects your daytime life (tiredness, mood, concentration, work)
On many nights, it takes 30 minutes or more to fall asleep, or you are awake for 30 minutes or more during the night
You usually spend 6–10 hours in bed trying to sleep
You can use a smartphone and are willing to complete a short daily sleep diary
You are able to attend clinic visits and phone or video check-ins

This study is not suitable if you:

This study is not suitable if you:

• Have used cannabis or CBD products in the last 30 days

• Currently use sleeping tablets, melatonin, or similar sleep aids

• Use weight-loss injections such as Ozempic, Wegovy, Saxenda, or Mounjaro

• Work overnight or rotating shifts

• Have been diagnosed with sleep apnoea or another sleep disorder

• Are pregnant or breastfeeding

• Are unable or unwilling to follow study guidelines

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What’s Involved

Why Participate in a Clinical Trial?

If you take part, your involvement may include:

Complete a short sleep diary on your phone each morning

Take 2 capsules once daily, about 2–3 hours before bedtime, with food

Participate for approximately 10–12 weeks in total

Attend a small number of clinic visits and phone or video check-ins

Complete questionnaires about your sleep and daytime wellbeing

Follow simple rules during the study, such as:

  • Avoiding caffeine after 4pm
  • Avoiding alcohol close to bedtime
  • Not using sleep trackers or smartwatches during the study

This study is best suited to people who can follow a regular routine and are comfortable using their phone daily.