NCT04962087 Health enSuite Insomnia: an App-based Treatment for Adult Chronic Insomnia
| NCT ID | NCT04962087 |
| Status | Recruiting |
| Phase | — |
| Sponsor | IWK Health Centre |
| Condition | Insomnia |
| Study Type | INTERVENTIONAL |
| Enrollment | 415 participants |
| Start Date | 2024-08-29 |
| Primary Completion | 2025-12-31 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 415 participants in total. It began in 2024-08-29 with a primary completion date of 2025-12-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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.
Eligibility Criteria
To be eligible for this study, participants must meet all of the following criteria: * Age 18 years or older Rationale: The intervention is designed for adults. Sleep patterns, treatment needs, and legal capacity for consent differ in children and adolescents, so participants must be legal adults to provide informed consent and to ensure relevance of the treatment content. * Experience one or more insomnia symptoms (e.g., difficulty falling asleep, staying asleep, or waking too early) at least 3 times per week for at least 3 months Rationale: This criterion aligns with standard diagnostic criteria for chronic insomnia (e.g., DSM-5, ICSD-3 (9,10), ensuring that the intervention targets individuals with persistent and clinically meaningful symptoms. * Have access to an internet-connected device (e.g., smartphone, tablet, or computer) Rationale: The CBT-I program is delivered entirely online via a mobile app or web platform. Participants must have reliable access to an internet-enabled device to complete program content, questionnaires, and sleep diaries. * Not currently working regular overnight shifts (e.g., shifts starting between 10:00 PM and 12:00 AM and ending between 6:00 AM and 8:00 AM) Rationale: Night shift work disrupts circadian rhythms and sleep patterns in ways that are distinct from chronic insomnia. Individuals who work night shifts may not benefit from a standardized sleep schedule and could face difficulties adhering to the intervention. * Not currently a parent of an infant under 1 year of age Rationale: Caring for an infant often involves frequent nighttime awakenings and irregular sleep patterns that are not necessarily reflective of insomnia. These participants may be unable to maintain a consistent sleep schedule as required by the intervention. * Not currently pregnant or trying to become pregnant. Rationale: Sleep disturbances during pregnancy often result from physiological and hormonal changes, which differ from behavioral insomnia. The program has not been designed or tested for use during pregnancy, and eligibility will change if pregnancy occurs during the study. * Have a total score greater than 7 on the Insomnia Severity Index (ISI) (11), indicating at least mild insomnia symptoms. Rationale: The ISI is a validated tool used to assess the severity of insomnia symptoms. A score of 8 or more indicates at least mild insomnia, which supports the need for intervention. Excluding participants with minimal or no symptoms ensures that the program is delivered to those who stand to benefit and that changes in symptoms are measurable.
Contact & Investigator
Patrick McGrath
PRINCIPAL INVESTIGATOR
IWK Health Centre
Frequently Asked Questions
Who can join the NCT04962087 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Insomnia. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT04962087 currently recruiting?
Yes, NCT04962087 is actively recruiting participants. Contact the research team at TeamHealthEnSuite@iwk.nshealth.ca for enrollment information.
Where is the NCT04962087 trial being conducted?
This trial is being conducted at Halifax, Canada.
Who is sponsoring the NCT04962087 clinical trial?
NCT04962087 is sponsored by IWK Health Centre. The principal investigator is Patrick McGrath at IWK Health Centre. The trial plans to enroll 415 participants.
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