RecruitingNAINTERVENTIONAL

Health enSuite Insomnia: an App-based Treatment for Adult Chronic Insomnia

This study is looking at an app called 'Health enSuite Insomnia'. This app offers a treatment known as Cognitive Behavioural Therapy for Insomnia (CBT-I) directly to your phone, tablet, or computer. CBT-I is a widely recommended approach for long-term sleep problems, focusing on changing thoughts and behaviours that affect sleep. The main goal of this research is to find out if this app-based programme can effectively help adults who have difficulty falling or staying asleep for three months or more. Currently, many people struggle to access in-person CBT-I, so this app aims to make this helpful treatment more available and easier for everyone to use.

At a glance

Status

Recruiting

Phase

Sponsor

IWK Health Centre

Enrolment target

415

Start

29 Aug 2024

Estimated completion

01 Jul 2026

Insomnia

What is this study about?

This study is all about helping people who have ongoing trouble sleeping, a common problem we call insomnia. If you find it hard to fall asleep, stay asleep, or wake up too early several nights a week for three months or more, you're experiencing chronic insomnia. This can leave you feeling tired and affect how well you get through your day.

Usually, the best way to treat long-term insomnia is with something called Cognitive Behavioural Therapy for Insomnia, or CBT-I. This therapy helps you understand and change the thoughts and habits that get in the way of a good night's sleep. While CBT-I is very effective, it's not always easy to access because there aren't enough therapists, or it might be difficult to get to appointments.

That's where this study comes in. Researchers have developed a new app called 'Health enSuite Insomnia' that delivers this CBT-I treatment directly to you through your phone, tablet, or computer. They want to see if this app can be just as helpful as in-person therapy in improving sleep and daily life for people with chronic insomnia. The idea is to make this proven treatment available to many more people who need it.

Key takeaways

Tests an app for long-term sleep problems (insomnia).
Uses a special type of therapy called CBT-I.
Aims to make CBT-I more accessible through technology.
For adults aged 18 and over with chronic insomnia.
Cannot participate if you work night shifts or have a young baby.

Who may be eligible?

This study is specifically for adults aged 18 and over who have been struggling with insomnia for at least three months, meaning they have trouble falling asleep, staying asleep, or wake up too early at least three times a week. You must also have your own internet-connected device, like a smartphone, tablet, or computer, to use the app.

However, this study might not be suitable if you work regular night shifts, as this can affect your sleep differently from typical insomnia. It's also not for new parents with a baby under one year old, or if you are pregnant or trying to get pregnant, because these situations often cause different types of sleep issues that this particular treatment isn't designed for.

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?
Have you had trouble sleeping (falling asleep, staying asleep, or waking too early) at least 3 nights a week for 3 months or more?
Do you have a smartphone, tablet, or computer with internet access?
Do you *not* work regular overnight shifts?
Are you *not* currently a parent of a baby under 1 year old?
Are you *not* pregnant or trying to get pregnant?

Answer every question to see your result.

What does participation involve?

The study involves testing an app-based programme. You would use the 'Health enSuite Insomnia' app on your own internet-connected device. The study is a "randomized controlled trial," which means some participants will get the new app treatment, and others might be in a comparison group. All participants will be asked to fill out questionnaires and keep sleep diaries to track their progress. The total duration of your involvement in the study is not specified in detail, but it will involve using the app and completing regular check-ins over a period.

Potential risks and benefits

Potential benefits of taking part include the chance to improve your sleep patterns and quality through a proven therapy approach delivered conveniently via an app, which could lead to better daily functioning. As with any new treatment, there's always a possibility it might not work for everyone, and individual results can vary. There are no direct medical risks with an app, but changes to sleep routines can take adjustment. You are free to withdraw from the study at any time without giving a reason, and it will not affect your usual medical care.

Locations (1)

Centre for Research in Family Health, IWK Health
Verified postcode
Halifax, Canada· Recruiting

Common questions

What is chronic insomnia?

Chronic insomnia means you have trouble falling or staying asleep, or you wake up too early, at least three nights a week for three months or more.

What is CBT-I?

CBT-I stands for Cognitive Behavioural Therapy for Insomnia. It's a type of therapy that helps you change thoughts and behaviours that affect your sleep.

How does the app work?

The 'Health enSuite Insomnia' app delivers CBT-I lessons and tools to your internet-connected device, guiding you through the programme to improve your sleep.

Do I need to see a doctor to join?

While you don't necessarily start with a doctor, it's always a good idea to discuss any new treatment options or studies with your GP.

What if I work nights or have a baby?

This study is not suitable for people who work regular night shifts or are parents of infants under one year old, as their sleep issues might be different.

How to find out more

Jaisheen Kour Reen

teamhealthensuite@iwk.nshealth.ca 1-877-341-8309 Official trial record

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