InsomniaNCT04962087

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

A study testing Experimental: Health enSuite Insomnia in people with Insomnia, run by IWK Health Centre at 1 site in Canada.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record

Search all trials

Trial 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. Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: Insomnia
What is being tested?: Experimental: Health enSuite Insomnia
Type of treatment: Lifestyle or therapy programme
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 415 participants
Where: 1 siteCanada
Study dates: 29 May 2026to 1 Apr 2027
Phase: Interventional
Are there results?: Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 years and older
All sexes
No healthy volunteers
Adult, Older adult

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.

Trial locations and contacts

1 site in 1 country.

Canada1 site

Centre for Research in Family Health, IWK Health
Halifax, Nova Scotia, B3K 6R8

Other trials in Canada

About this study

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

Read the 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.

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
Being tested: Experimental: Health enSuite Insomnia
Keywords: Insomnia, Deprescribing, Cognitive Behavioural Therapy
Medical subject headings: Sleep Initiation and Maintenance Disorders

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Experimental: Health enSuite InsomniaBehavioural
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.

Study groups in NCT04962087
Study group	Role	What they receive
Health enSuite Insomnia	Experimental	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. Receives: Behavioral: Experimental: Health enSuite Insomnia
Waitlist Control	No intervention	Participants allocated to the control group will not have access to Health enSuite Insomnia CBT-I content until the end of the trial. During the trial, they will receive treatment as usual and will not be restricted from accessing other standard care services for insomnia treatment.

What is being measured

The primary outcome is the main question the study is designed to answer.

Change in Insomnia Severity Index (ISI) Score
The ISI is a 7-item questionnaire measuring insomnia severity, dissatisfaction with sleep, interference with daily functioning, and daytime impairment. Scores range from 0-28, with higher scores indicating more severe insomnia.
Measured: Baseline assessment, 2 months post-randomization, 5 months post-randomization

Secondary outcomes (5)

Change in Depression, Anxiety, and Stress Scores (DASS-21)
The DASS-21 is a 21-item questionnaire measuring psychological distress across three subscales: depression, anxiety, and stress. Each item is scored 0-3, and higher scores indicate greater distress.
Measured: Baseline assessment, 2 months post-randomization, 5 months post-randomization
Change in Sleep Efficiency
Sleep efficiency will be calculated from sleep diary data as the ratio of total sleep time to time in bed (percentage).
Measured: Baseline assessment, 2 months post-randomization, 5 months post-randomization
Change in Total Sleep Time
Total sleep time in hours will be calculated from daily sleep diaries. Unit of Measure: Hours of sleep (hours/night).
Measured: Baseline assessment, 2 months post-randomization, 5 months post-randomization
Change in Sleep Onset Latency
Sleep onset latency (minutes taken to fall asleep) will be measured via sleep diary.
Unit of Measure: Minutes.
Measured: Baseline assessment, 2 months post-randomization, 5 months post-randomization
Change in Wake After Sleep Onset (WASO)
WASO (total time awake after initially falling asleep) will be recorded via sleep diary.
Unit of Measure: Minutes.
Measured: Baseline assessment, 2 months post-randomization, 5 months post-randomization

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

29 May 20261 Apr 2027

First posted14 Jul 2021
Study start29 May 2026
Primary completion31 Mar 2027 (estimated)
Study completion1 Apr 2027 (estimated)

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (38)Papers the sponsor has linked to this study.
Other trials for InsomniaStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Model description: This project consists of a pragmatic randomized controlled trial (RCT). The Consolidated Standards of Reporting Trials (CONSORT) recommendations (http://www.consort-statement.org/) will guide the methodology. Participants will be randomly allocated in a 1:1 ratio to either the intervention group or a waitlist control group. Participants in both groups will complete self-assessments including key outcome measures at baseline before starting the study, at two months post-randomization, and again at five months post-randomization. Participants in the intervention group will receive the full Health enSuite Insomnia program immediately after being randomized to this group. Participants in the waitlist control group will be waitlisted during the study. After their participation in the study has ended, participants in the waitlist control group will be given access to the full Health enSuite Insomnia program for two months.
Masking: None (open label)
Enrolment: 415 participants (estimated)

IDs, dates and publications

ClinicalTrials.gov ID: NCT04962087
Sponsor's protocol ID: 1026706
Status last verified: Nov 2026
First submitted: 14 Jun 2021
Last updated: 4 Nov 2026
Results posted: No
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: Yes: De-identified data sets may be retained and stored within the Centre for Research in Family Health as required for future research or program development, if merited. During Consent, participants will be offered the option of allowing their de-identified study data to be re-used by other approved researchers under the conditions that the research projects are approved by an appropriate ethics board and the researchers sign an agreement ensuring confidentiality and restricting data use only to the approved study. A database will be created containing only the data for those participants who agree will be available to researchers who meet these criteria.

Publications

Chaput JP, Yau J, Rao DP, Morin CM. Prevalence of insomnia for Canadians aged 6 to 79. Health Rep. 2018 Dec 19;29(12):16-20.
PubMed 30566205
Morin CM, Benca R. Chronic insomnia. Lancet. 2012 Mar 24;379(9821):1129-41. doi: 10.1016/S0140-6736(11)60750-2. Epub 2012 Jan 20.
PubMed 22265700
Management of Chronic Insomnia Disorder in Adults: A Clinical Practice Guideline From the American College of Physicians. Ann Intern Med. 2016 Jul 19;165(2). doi: 10.7326/P16-9016. Epub 2016 May 3. No abstract available.
PubMed 27135191
Schutte-Rodin S, Broch L, Buysse D, Dorsey C, Sateia M. Clinical guideline for the evaluation and management of chronic insomnia in adults. J Clin Sleep Med. 2008 Oct 15;4(5):487-504.
PubMed 18853708
van Straten A, van der Zweerde T, Kleiboer A, Cuijpers P, Morin CM, Lancee J. Cognitive and behavioral therapies in the treatment of insomnia: A meta-analysis. Sleep Med Rev. 2018 Apr;38:3-16. doi: 10.1016/j.smrv.2017.02.001. Epub 2017 Feb 9.
PubMed 28392168
Trauer JM, Qian MY, Doyle JS, Rajaratnam SM, Cunnington D. Cognitive Behavioral Therapy for Chronic Insomnia: A Systematic Review and Meta-analysis. Ann Intern Med. 2015 Aug 4;163(3):191-204. doi: 10.7326/M14-2841.
PubMed 26054060
Koffel E, Bramoweth AD, Ulmer CS. Increasing access to and utilization of cognitive behavioral therapy for insomnia (CBT-I): a narrative review. J Gen Intern Med. 2018 Jun;33(6):955-962. doi: 10.1007/s11606-018-4390-1. Epub 2018 Apr 4.
PubMed 29619651
Holbrook AM, Crowther R, Lotter A, Cheng C, King D. Meta-analysis of benzodiazepine use in the treatment of insomnia. CMAJ. 2000 Jan 25;162(2):225-33.
PubMed 10674059
Pottie K, Thompson W, Davies S, Grenier J, Sadowski CA, Welch V, Holbrook A, Boyd C, Swenson R, Ma A, Farrell B. Deprescribing benzodiazepine receptor agonists: Evidence-based clinical practice guideline. Can Fam Physician. 2018 May;64(5):339-351.
PubMed 29760253
Glass J, Lanctot KL, Herrmann N, Sproule BA, Busto UE. Sedative hypnotics in older people with insomnia: meta-analysis of risks and benefits. BMJ. 2005 Nov 19;331(7526):1169. doi: 10.1136/bmj.38623.768588.47. Epub 2005 Nov 11.
PubMed 16284208
Farrell B, Tsang C, Raman-Wilms L, Irving H, Conklin J, Pottie K. What are priorities for deprescribing for elderly patients? Capturing the voice of practitioners: a modified delphi process. PLoS One. 2015 Apr 7;10(4):e0122246. doi: 10.1371/journal.pone.0122246. eCollection 2015.
PubMed 25849568
Pollmann AS, Murphy AL, Bergman JC, Gardner DM. Deprescribing benzodiazepines and Z-drugs in community-dwelling adults: a scoping review. BMC Pharmacol Toxicol. 2015 Jul 4;16:19. doi: 10.1186/s40360-015-0019-8.
PubMed 26141716
Lee JY, Farrell B, Holbrook AM. Deprescribing benzodiazepine receptor agonists taken for insomnia: a review and key messages from practice guidelines. Pol Arch Intern Med. 2019 Jan 31;129(1):43-49. doi: 10.20452/pamw.4391. Epub 2018 Dec 13.
PubMed 30543200
Morin CM, Vallieres A, Guay B, Ivers H, Savard J, Merette C, Bastien C, Baillargeon L. Cognitive behavioral therapy, singly and combined with medication, for persistent insomnia: a randomized controlled trial. JAMA. 2009 May 20;301(19):2005-15. doi: 10.1001/jama.2009.682.
PubMed 19454639
Ng BJ, Le Couteur DG, Hilmer SN. Deprescribing Benzodiazepines in Older Patients: Impact of Interventions Targeting Physicians, Pharmacists, and Patients. Drugs Aging. 2018 Jun;35(6):493-521. doi: 10.1007/s40266-018-0544-4.
PubMed 29705831

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All Insomnia trials

Study at a glance

From the registry record, last updated by the sponsor on 4 Nov 2026. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Randomized Controlled Trial to Evaluate Health enSuite Insomnia: an App-based Treatment for Adult Chronic Insomnia
ClinicalTrials.gov ID: NCT04962087
Acronym / sponsor ID: 1026706
Conditions: Insomnia
Keywords: Insomnia, Deprescribing, Cognitive Behavioural Therapy
Study type: Interventional
Recruitment status: Active, not recruiting
Enrolment: 415 participants (estimated)
Lead sponsor: IWK Health CentreUniversity, hospital or other
Study start: 29 May 2026 (actual)
Primary completion: 31 Mar 2027 (estimated)
Study completion: 1 Apr 2027 (estimated)
First posted: 14 Jul 2021 (actual)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

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.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 2
Model description: This project consists of a pragmatic randomized controlled trial (RCT). The Consolidated Standards of Reporting Trials (CONSORT) recommendations (http://www.consort-statement.org/) will guide the methodology. Participants will be randomly allocated in a 1:1 ratio to either the intervention group or a waitlist control group. Participants in both groups will complete self-assessments including key outcome measures at baseline before starting the study, at two months post-randomization, and again at five months post-randomization. Participants in the intervention group will receive the full Health enSuite Insomnia program immediately after being randomized to this group. Participants in the waitlist control group will be waitlisted during the study. After their participation in the study has ended, participants in the waitlist control group will be given access to the full Health enSuite Insomnia program for two months.

Arm	Type	Receives
Health enSuite Insomnia	Experimental	Behavioral: Experimental: Health enSuite InsomniaHealth 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.
Waitlist Control	No intervention	–Participants allocated to the control group will not have access to Health enSuite Insomnia CBT-I content until the end of the trial. During the trial, they will receive treatment as usual and will not be restricted from accessing other standard care services for insomnia treatment.

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Experimental: Health enSuite InsomniaHealth 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.	Behavioural	Health enSuite Insomnia

Primary outcome

Change in Insomnia Severity Index (ISI) Score
Time frame: Baseline assessment, 2 months post-randomization, 5 months post-randomization
The ISI is a 7-item questionnaire measuring insomnia severity, dissatisfaction with sleep, interference with daily functioning, and daytime impairment. Scores range from 0-28, with higher scores indicating more severe insomnia.

5 secondary outcomes

Change in Depression, Anxiety, and Stress Scores (DASS-21)
Time frame: Baseline assessment, 2 months post-randomization, 5 months post-randomization
Change in Sleep Efficiency
Time frame: Baseline assessment, 2 months post-randomization, 5 months post-randomization
Change in Total Sleep Time
Time frame: Baseline assessment, 2 months post-randomization, 5 months post-randomization
Change in Sleep Onset Latency
Time frame: Baseline assessment, 2 months post-randomization, 5 months post-randomization
Change in Wake After Sleep Onset (WASO)
Time frame: Baseline assessment, 2 months post-randomization, 5 months post-randomization

Results and safety

This study is still under way. Results are not available in the source record yet.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 4 Nov 2026.
Background: PubMed 30566205Chaput JP, Yau J, Rao DP, Morin CM. Prevalence of insomnia for Canadians aged 6 to 79. Health Rep. 2018 Dec 19;29(12):16-20.
Background: PubMed 22265700Morin CM, Benca R. Chronic insomnia. Lancet. 2012 Mar 24;379(9821):1129-41. doi: 10.1016/S0140-6736(11)60750-2. Epub 2012 Jan 20.
Background: PubMed 27135191Management of Chronic Insomnia Disorder in Adults: A Clinical Practice Guideline From the American College of Physicians. Ann Intern Med. 2016 Jul 19;165(2). doi: 10.7326/P16-9016. Epub 2016 May 3. No abstract available.
Background: PubMed 18853708Schutte-Rodin S, Broch L, Buysse D, Dorsey C, Sateia M. Clinical guideline for the evaluation and management of chronic insomnia in adults. J Clin Sleep Med. 2008 Oct 15;4(5):487-504.
Background: PubMed 28392168van Straten A, van der Zweerde T, Kleiboer A, Cuijpers P, Morin CM, Lancee J. Cognitive and behavioral therapies in the treatment of insomnia: A meta-analysis. Sleep Med Rev. 2018 Apr;38:3-16. doi: 10.1016/j.smrv.2017.02.001. Epub 2017 Feb 9.
Background: PubMed 26054060Trauer JM, Qian MY, Doyle JS, Rajaratnam SM, Cunnington D. Cognitive Behavioral Therapy for Chronic Insomnia: A Systematic Review and Meta-analysis. Ann Intern Med. 2015 Aug 4;163(3):191-204. doi: 10.7326/M14-2841.
Background: PubMed 29619651Koffel E, Bramoweth AD, Ulmer CS. Increasing access to and utilization of cognitive behavioral therapy for insomnia (CBT-I): a narrative review. J Gen Intern Med. 2018 Jun;33(6):955-962. doi: 10.1007/s11606-018-4390-1. Epub 2018 Apr 4.
Background: PubMed 10674059Holbrook AM, Crowther R, Lotter A, Cheng C, King D. Meta-analysis of benzodiazepine use in the treatment of insomnia. CMAJ. 2000 Jan 25;162(2):225-33.
Background: PubMed 29760253Pottie K, Thompson W, Davies S, Grenier J, Sadowski CA, Welch V, Holbrook A, Boyd C, Swenson R, Ma A, Farrell B. Deprescribing benzodiazepine receptor agonists: Evidence-based clinical practice guideline. Can Fam Physician. 2018 May;64(5):339-351.
Background: PubMed 16284208Glass J, Lanctot KL, Herrmann N, Sproule BA, Busto UE. Sedative hypnotics in older people with insomnia: meta-analysis of risks and benefits. BMJ. 2005 Nov 19;331(7526):1169. doi: 10.1136/bmj.38623.768588.47. Epub 2005 Nov 11.
Background: PubMed 25849568Farrell B, Tsang C, Raman-Wilms L, Irving H, Conklin J, Pottie K. What are priorities for deprescribing for elderly patients? Capturing the voice of practitioners: a modified delphi process. PLoS One. 2015 Apr 7;10(4):e0122246. doi: 10.1371/journal.pone.0122246. eCollection 2015.
Background: PubMed 26141716Pollmann AS, Murphy AL, Bergman JC, Gardner DM. Deprescribing benzodiazepines and Z-drugs in community-dwelling adults: a scoping review. BMC Pharmacol Toxicol. 2015 Jul 4;16:19. doi: 10.1186/s40360-015-0019-8.
Individual participant dataSharing planned: Yes. De-identified data sets may be retained and stored within the Centre for Research in Family Health as required for future research or program development, if merited. During Consent, participants will be offered the option of allowing their de-identified study data to be re-used by other approved researchers under the conditions that the research projects are approved by an appropriate ethics board and the researchers sign an agreement ensuring confidentiality and restricting data use only to the approved study. A database will be created containing only the data for those participants who agree will be available to researchers who meet these criteria.

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Patrick McGrath principal investigator

IWK Health Centre

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing Experimental: Health enSuite Insomnia in people with Insomnia, run by IWK Health Centre at 1 site in Canada.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: under way, not looking for participants, as of the sponsor's last update on 4 Nov 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change in Insomnia Severity Index (ISI) Score (time frame: Baseline assessment, 2 months post-randomization, 5 months post-randomization). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04962087, which also lists 38 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Nov 2026.