NCT04962087

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

Randomized Controlled Trial to Evaluate Health enSuite Insomnia: an App-based Treatment for Adult Chronic Insomnia

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 415 (estimated)
• Sponsor: IWK Health Centre · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This project consists of a randomized controlled trial. The objective of this trial is to test the effectiveness of an app-based cognitive behavioral program for insomnia (Health enSuite: Insomnia) in reducing insomnia symptoms.

Detailed description

Insomnia or insufficient sleep is one of the most prevalent public health issues. Nearly 1 in 4 Canadians over the age of 18 years report having difficulty falling asleep or maintaining sleep, the majority of whom have experienced these insomnia symptoms for more than a year. Chronic insomnia is characterized by one or more of the following symptoms occurring for at least three nights per week for at least 3 months: difficulty falling asleep, trouble maintaining sleep, difficulty in getting back to sleep, poor quality of sleep, and waking up too early the next morning. These symptoms persist despite adequate opportunity for sleep and are accompanied by significant impairments in daytime functioning. Cognitive behavioral therapy for insomnia (CBT-I) is a multi-component intervention approach that is recommended as the first line of treatment for patients with persistent insomnia. It targets beliefs, thoughts, and expectations related to sleep as well as behavioral factors that result in sleep loss (sleep schedules, caffeine intake prior to bedtime, bright light in bedroom). These interventions have been found to improve the quality and the duration of sleep and improve daytime functioning. Despite the efficacy of CBT-I programs, they are not readily available to most patients. Therefore, our goal is to develop a CBT-I program that can be delivered through an internet connected phone, tablet, or computer and provide effective treatment to a wide range of people with chronic insomnia. Given that many individuals seek help for sleep problems online or face barriers accessing in-person care, internet-based CBT-I offers a scalable and accessible solution for those experiencing chronic insomnia. Sleep medications are commonly used to manage insomnia symptoms. These include benzodiazepines such as temazepam and non-benzodiazepines like zopiclone, zolpidem, and zaleplon (often referred to as "Z drugs"). While these benzodiazepine receptor agonists (BZRAs) can be effective in the short term, long-term use is associated with diminishing benefits and potential risks, such as side effects, dependence, and-particularly in older adults-falls and cognitive impairment. Given these concerns, there is growing recognition of the importance of expanding access to non-pharmacological, evidence-based treatments for insomnia. Cognitive behavioral therapy for insomnia (CBT-I) is one such approach, but it remains underutilized due to limited availability. A widely accessible, app-based CBT-I program has the potential to fill this gap and offer a safer, long-term solution for individuals struggling with chronic insomnia. This project consists of a randomized controlled trial. The objective of this trial is to test the effectiveness of an app-based cognitive behavioral program for insomnia (Health enSuite: Insomnia) in reducing insomnia symptoms. The objectives will be to assess the effectiveness of CBT-I delivered through the Health enSuite app in: * Reducing the severity of insomnia symptoms (primary outcome) * Increasing sleep efficiency and total sleep time (secondary outcomes) * Reducing sleep onset latency, time in bed, and the duration and frequency of awakenings at night (secondary outcomes) * Reducing symptoms of psychological distress, anxiety, and depression (secondary outcomes) User engagement and satisfaction with Health enSuite: Insomnia will also be evaluated to inform subsequent efforts to make this program available on a larger scale.

Conditions

• Insomnia

Interventions

Type	Name	Description
BEHAVIORAL	Experimental: Health enSuite Insomnia	Health enSuite: Insomnia has been designed based on established cognitive behavioral treatments for insomnia (2,5,6) and adapted to fit an automated interactive platform available via an internet enabled device. Previous research has found that CBT for insomnia can be delivered via a web-based platform (15,16). The program is divided into a series of treatment modules or levels that will be delivered over the course of 8 weeks. The content of these 8 levels includes the following components, a sleep diary, Introduction to Health EnSuite Insomnia, Sleep restriction clock, Medications, Herbal Remedies \& Sleep, Chronobiology \& Sleep Timing, Sleep hygiene, Relaxation techniques, Changing Negative Thoughts Related to Sleep, Light and Sleep.

Timeline

• Start date: 2024-08-29
• Primary completion: 2025-12-31
• Completion: 2026-07-01
• First posted: 2021-07-14
• Last updated: 2025-08-29

Locations

1 site across 1 country: Canada