Efficacy of CBT-I and Lemborexant Medication for Different Subtypes of Chronic Insomnia
This study aims to find the best ways to help people struggling with long-term sleep problems (insomnia), especially if they also feel anxious or depressed. Researchers are comparing two main approaches: a talking therapy called Cognitive Behavioral Treatment for Insomnia (CBT-I) and a medication called lemborexant. They will also compare these to a dummy pill (placebo) to see which is most effective. The study also wants to understand if the amount of sleep someone gets initially affects how well these treatments work. By looking at sleep and mood, the goal is to improve treatment for people with different types of insomnia.
At a glance
What is this study about?
If you're finding it hard to sleep night after night, you're not alone. This study is designed to help us better understand and treat long-term sleep problems, known as chronic insomnia, especially when people are also feeling down or worried, which often go hand-in-hand with sleep difficulties.
The main idea is to compare two common approaches that could help: one is a special type of talking therapy called Cognitive Behavioral Treatment for Insomnia (CBT-I). This therapy helps you change thoughts and habits that get in the way of good sleep. The other is a sleeping medication called lemborexant. Researchers want to see which of these works better for improving sleep and lifting mood, compared to taking a dummy pill (placebo).
Additionally, the study will look at whether people who sleep very little to begin with respond differently to these treatments compared to those who get a bit more sleep. This could help doctors recommend the most suitable treatment for each individual.
Key takeaways
- This study compares talking therapy (CBT-I) and a sleeping tablet for insomnia.
- It also looks at how different people with insomnia respond to these treatments.
- You might receive CBT-I, lemborexant, or a dummy pill.
- Participation involves 8 weeks of treatment and a 6-month follow-up.
- It could help improve your sleep and mood or assist in finding better treatments for others.
Who may be eligible?
To join this study, you need to be at least 18 years old and have had ongoing trouble sleeping that fits the description of insomnia. You should also be experiencing some mild anxiety or low mood.
You'll need to be able to read and understand either French or English, and have access to a smartphone, tablet, or computer with an internet connection to take part.
There are some reasons why you might not be able to join. For example, if you have certain serious mental health conditions, are using drugs or alcohol heavily, or have serious ongoing medical problems. If you're currently taking sleep medication, certain antidepressants, or cannabis products for sleep often, or have other sleep disorders like sleep apnoea, you also wouldn't be able to take part. Regular heavy drinking or working night shifts often would also exclude you.
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?
- Do you often struggle with falling asleep or staying asleep?
- Do you also feel a bit anxious or low?
- Can you read and speak English or French?
- Do you have access to a smartphone/computer and internet at home?
- Are you able to stop taking any current sleep medications for the study?
What does participation involve?
If you join the study, you'll first have some checks to make sure it's right for you. If you qualify, you'll be randomly put into one of three groups: one group will receive CBT-I through six therapy sessions over eight weeks; another group will take the lemborexant medication; and the third group will take a dummy pill (placebo) that looks just like the real medication. Both medication groups will have six consultations over eight weeks.
You'll be assessed at the beginning, right after the eight-week treatment period, and then again six months later to see how you're doing. The total duration of your active participation, including follow-up, will be around 6 months.
Potential risks and benefits
Locations (1)
- Université Laval Centre d'étude des troubles du sommeilVerified postcodeQuébec, Canada· Recruiting
Common questions
What is CBT-I?
CBT-I stands for Cognitive Behavioral Treatment for Insomnia. It's a type of talking therapy that helps you change thoughts and habits that are making your sleep problems worse.
What is lemborexant?
Lemborexant is a medication designed to help with sleep problems by affecting certain chemicals in your brain that control the sleep-wake cycle.
What does 'placebo' mean?
A placebo is a dummy pill that looks exactly like the real medication but doesn't contain any active ingredients. It helps researchers see if the real medicine is truly effective.
Will I know which treatment I'm getting?
No, you won't know if you're getting the active medication or the placebo. This helps prevent your expectations from affecting the results. The doctors providing the medication won't know either.
How long will I be involved in the study?
You'll be involved for an 8-week treatment period, followed by a check-up 6 months later. So, around 6 months in total from start to finish.
How to find out more
Manon Lamy
Always speak to your GP or specialist before deciding to take part in a study.
Interested in taking part?
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