Are you tired of sleepless nights?
Researchers are investigating a potential new treatment for insomnia. In order to be considered to take part in the study, you’ll need to meet the following criteria:
- 18 years of age or older
- Have difficulty getting to sleep, staying asleep and/or waking up earlier in the morning than desired, for at least the past 3 months (or are diagnosed with insomnia)
- Have a regular time period spent in bed, either sleeping or trying to sleep (e.g. you go to bed around 9pm and get up at 6am)
NSW, QLD, SA, VIC, WA
Up to 16 weeksRead more
If you take part in the research study you will receive:
Reimbursement of costs
For out-of-pocket expenses, such as travel and parking.
Contribution to research
Results from this study may benefit others in the future
Free study-related medical care
You may gain access to new research treatments, before they are widely available.
No overnight stays!
All study visits are out-patient only.
Who can take part in this study?
In order to be eligible to participate in the study, you must meet all of the following:
- You are 18 years of age or older
- You’ve had difficulty getting to sleep, staying asleep and/or waking up earlier in the morning than desired, for at least the past 3 months (or are diagnosed with insomnia)
- You have a regular time period spent in bed, either sleeping or trying to sleep (e.g. you go to bed around 9pm and get up at 6am)
- You have access to a smartphone
Who is unable to take part in this study?
Unfortunately, if you meet any of the following, this study is not the right fit for you:
- You consume more than 300mg or about 3 cups of caffeinated drinks per day (and are not willing to reduce your intake for the duration of the trial)
- Your insomnia results from another sleep-wake disorder (e.g. narcolepsy, a breathing-related sleep condition, restless leg syndrome, or any other related condition)
- You nap more than 3 times a week
- You are currently on/taking any treatments for insomnia
How long will the study take?
If you agree to take part, and the study is suitable for you, your participation in the study is expected to last up to 16 weeks. You will be required to return to the study site approximately 6 times and have approximately 3 telephone calls with the study team.
This study has 3 periods:
- Screening Period (6 weeks)
- Treatment Period (8 weeks)
- Follow-up Period (2 weeks)
As part of the study you will be asked to:
- Complete a daily study diary
- Complete questionnaires
- Wear an Actigraph device (and refrain from monitoring your sleep using other devices such as FitBits or Apple Watches).
What is the purpose of this study?
Avecho has recognised that existing over-the-counter medications for insomnia either have poor efficacy or are associated with a high degree of next day impairment. There is currently an unmet treatment need for an over-the-counter, effective, fast-acting treatment for insomnia that provides natural, restorative sleep.
They have developed a potential new treatment for insomnia called CBD TPM (the study drug), with the goal of filling this therapeutic gap. This study aims to investigate the effects the study drug has on you and your condition.
What is insomnia?
Insomnia is a common sleep disorder in which people have difficulty falling or staying asleep. It is often defined as inadequate or poor-quality sleep despite having adequate opportunity to sleep. In Australia 12% of the population is clinically diagnosed with chronic insomnia, and as many as 60% of the population have at least one symptom of insomnia (Sleep Health Foundation Report). Some of these symptoms may include:
- Difficulty getting to sleep
- Interrupted sleep during the night and trouble going back to sleep
- Waking up too early
- Not feeling well-rested after a night's sleep
- Daytime tiredness or sleepiness
- Irritability, depression or anxiety
- Difficulty paying attention, focusing on tasks or remembering
Insomnia has been associated with increased risk of various serious chronic medical and psychiatric conditions. With the prevalence of insomnia growing, there is an urgent need for more effective treatments to manage its symptoms and to help Australians have better sleep!
Where is this study being conducted?
Here is a list of all of the sites who are currently recruiting for this study:
- Blacktown - Paratus Clinical Research Western Sydney
- Kanwal - Paratus Clinical Research Central Coast
- Maroubra - Maroubra Medical Centre
- Albion - Paratus Clinical Research Brisbane Clinic
- Fortitude Valley - Holdsworth House Medical Brisbane
- Bedford Park - Flinders Medical Centre
- Heidelberg - Austin Hospital
- Melbourne - Alfred Hospital
- Clayton - Monash Medical Centre
- Crawley - The University of Western Australia
What if I have other questions about the study?
Our friendly Patient Experience team is on hand to answer any questions you may have. Simply send an email to firstname.lastname@example.org.