Health enSuite App for Insomnia
Recruiting in Palo Alto (17 mi)
Overseen byPatrick McGrath
Age: 18+
Sex: Any
Travel: May Be Covered
Time Reimbursement: Varies
Trial Phase: Academic
Recruiting
Sponsor: IWK Health Centre
Must be taking: BZRA, Benzodiazepines
Disqualifiers: No internet, Pregnant, Shift work, others
No Placebo Group
Trial Summary
What is the purpose of this trial?This project consists of two independent but related randomized controlled trials. Trial 1 will focus on people who are not currently prescribed BZRA medications. Trial 2 will focus on people who have been taking BZRA medications and are initiating gradual tapering of these medications as recommended and supervised by their primary health care provider.
Will I have to stop taking my current medications?
If you are in Trial 1, you should not be on any insomnia medications. If you are in Trial 2, you will need to gradually reduce your BZRA medications under your doctor's guidance.
What data supports the effectiveness of the Health enSuite Insomnia treatment for insomnia?
The research suggests that mobile health applications, like Health enSuite Insomnia, may help improve insomnia care, but there is limited data on their effectiveness. Cognitive Behavioral Therapy for Insomnia, which is often included in such apps, is recommended as a first-line treatment for chronic insomnia.
12345Is the Health enSuite App for Insomnia safe for humans?
The research does not provide specific safety data for the Health enSuite App for Insomnia, but it mentions that behavioral treatments for insomnia, like cognitive behavioral therapy, are generally considered safe.
16789How does the Health enSuite App for Insomnia treatment differ from other insomnia treatments?
The Health enSuite App for Insomnia is unique because it leverages a mobile health application to provide personalized advice on sleep hygiene, relaxation techniques, and stimulus control, potentially offering a more accessible and autonomous way to manage insomnia compared to traditional therapies.
18101112Eligibility Criteria
Adults over 18 with chronic insomnia, experiencing symptoms at least thrice a week for over three months. The trial has two parts: one for those not on insomnia meds and another for those prescribed up to two BZRA or benzodiazepine medications and are tapering off under doctor supervision.Inclusion Criteria
I am 18 years old or older.
I have had trouble sleeping at least 3 nights a week for the last 3 months.
I am not taking any medications for insomnia.
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Trial Timeline
Screening
Participants are screened for eligibility to participate in the trial
2-4 weeks
Treatment
Participants receive the Health enSuite Insomnia app treatment or psychoeducation control over 6-8 weeks
6-8 weeks
Weekly app-based modules
Follow-up
Participants are monitored for changes in insomnia severity and medication use
12 weeks
Assessments at 8 and 20 weeks post-randomization
Deprescribing
Participants in Trial 2 initiate a gradual medication tapering schedule
8-20 weeks
Participant Groups
The study is testing an app-based treatment called Health enSuite Insomnia in two randomized controlled trials. One trial is for adults not taking BZRA meds, while the other involves participants who are gradually stopping their BZRA medication use.
4Treatment groups
Experimental Treatment
Active Control
Group I: Health enSuite Insomnia - DeprescribingExperimental Treatment1 Intervention
All participants in Trial 2 will be initiating a gradual medication tapering schedule recommended to them by their physician. The module physicians use to refer their patients to the study includes a section where they fill out a brief drug history for sleep medications. This information is then used to generate a tapering schedule that the health care provider will review with their patient. Health care providers are responsible for providing appropriate medication counselling and follow-up care to supervise deprescribing. This study does not place any restriction on the usual care participants will receive.
Group II: Health enSuite InsomniaExperimental Treatment1 Intervention
Health enSuite: Insomnia has been designed based on established cognitive behavioural treatments for insomnia and adapted to fit an automated interactive platform available via an internet enabled device. The program is divided into a series of treatment modules or levels that will be delivered over the course of 6-8 weeks. The content of these 6 levels includes the following components, a sleep diary, sleep restriction clock, sleep hygiene, relaxation techniques, sleep related thoughts and beliefs, and involving a support person.
Group III: Psychoeducation ControlActive Control1 Intervention
Participants allocated to the Control group will receive a version of the Health enSuite Insomnia app that contains a static psychoeducation module. It will contain information related to insomnia and its treatment. Topics covered will include a brief description of cognitive behavioural therapy for insomnia.
Group IV: Psychoeducation Control - DeprescribingActive Control1 Intervention
Participants allocated to the Control group will receive a version of the Health enSuite Insomnia app that contains a static psychoeducation module. It will contain information related to insomnia and its treatment. Topics covered will include a brief description of cognitive behavioural therapy for insomnia and information about the benefits of medication de-prescribing for those in Trial 2.
Find a Clinic Near You
Research Locations NearbySelect from list below to view details:
Centre for Research in Family Health, IWK HealthHalifax, Canada
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Who Is Running the Clinical Trial?
IWK Health CentreLead Sponsor
References
Help for insomnia from the app store? A standardized rating of mobile health applications claiming to target insomnia. [2023]A large number of mobile health applications claiming to target insomnia are available in commercial app stores. However, limited information on the quality of these mobile health applications exists. The present study aimed to systematically search the European Google Play and Apple App Store for mobile health applications targeting insomnia, and evaluate the quality, content, evidence base and potential therapeutic benefit. Eligible mobile health applications were evaluated by two independent reviewers using the Mobile Application Rating Scale-German, which ranges from 1 - inadequate to 5 - excellent. Of 2236 identified mobile health applications, 53 were included in this study. Most mobile health applications (68%) had a moderate overall quality. Concerning the four main subscales of the Mobile Application Rating Scale-German, functionality was rated highest (M = 4.01, SD = 0.52), followed by information quality (M = 3.49, SD = 0.72), aesthetics (M = 3.31, SD = 1.04) and engagement (M = 3.02, SD = 1.03). While scientific evidence was identified for 10 mobile health applications (19%), only one study employed a randomized controlled design. Fifty mobile health applications featured sleep hygiene/psychoeducation (94%), 27 cognitive therapy (51%), 26 relaxation methods (49%), 24 stimulus control (45%), 16 sleep restriction (30%) and 24 sleep diaries (45%). Mobile health applications may have the potential to improve the care of insomnia. Yet, data on the effectiveness of mobile health applications are scarce, and this study indicates a large variance in the quality of the mobile health applications. Thus, independent information platforms are needed to provide healthcare seekers and providers with reliable information on the quality and content of mobile health applications.
Efficacy of a Smartphone-Based Virtual Companion to Treat Insomniac Complaints in the General Population: Sleep Diary Monitoring Versus an Internet Autonomous Intervention. [2023](1) Background: Insomnia is the most prevalent sleep disorder worldwide and cognitive behavioral therapy is the front-line treatment. Digital health technologies have a role to play in screening and delivering interventions remotely and without the need for human intervention. The KANOPEE app, which provides a screening and behavioral intervention for insomnia symptoms through an interaction with a virtual agent, showed encouraging results in previous studies during and after the COVID-19 lockdown, but has not yet been evaluated in a controlled study. This study aims at comparing the benefits of KANOPEE, a smartphone application dealing with insomnia complaints, with another application proposing an electronic sleep diary named “My Sleep Diary”. The acceptance and potential benefits of these digital solutions are tested in real-life settings (i.e., without soliciting human medical resources) and in the general population. (2) Methods: Subjects were included if they downloaded one of the apps between December 2020 and October 2021, and were of legal age. Both apps were available on downloading platforms in France. Primary outcome was Insomnia Severity Index (ISI), and secondary outcomes were total sleep time (TST), sleep efficiency (SE) and wake time after sleep onset (WASO). (3) Results: A total of 535 users completed the intervention with KANOPEE and 489 users completed My Sleep Diary, both for 17 days. KANOPEE users improved their ISI score significantly more than sleep diary users (interaction Time*Group: F(2,2002) = 17.3, p
Systematic Review of Clinical Practice Guidelines for Insomnia Disorder. [2023]This systematic review assessed the quality of clinical practice guidelines (CPGs) on the treatment of insomnia disorder and their reporting of recommendations, while summarizing the evidence and providing guidance on an algorithmic approach to appropriate pharmacological treatment.
European guideline for the diagnosis and treatment of insomnia. [2022]This European guideline for the diagnosis and treatment of insomnia was developed by a task force of the European Sleep Research Society, with the aim of providing clinical recommendations for the management of adult patients with insomnia. The guideline is based on a systematic review of relevant meta-analyses published till June 2016. The target audience for this guideline includes all clinicians involved in the management of insomnia, and the target patient population includes adults with chronic insomnia disorder. The GRADE (Grading of Recommendations Assessment, Development and Evaluation) system was used to grade the evidence and guide recommendations. The diagnostic procedure for insomnia, and its co-morbidities, should include a clinical interview consisting of a sleep history (sleep habits, sleep environment, work schedules, circadian factors), the use of sleep questionnaires and sleep diaries, questions about somatic and mental health, a physical examination and additional measures if indicated (i.e. blood tests, electrocardiogram, electroencephalogram; strong recommendation, moderate- to high-quality evidence). Polysomnography can be used to evaluate other sleep disorders if suspected (i.e. periodic limb movement disorder, sleep-related breathing disorders), in treatment-resistant insomnia, for professional at-risk populations and when substantial sleep state misperception is suspected (strong recommendation, high-quality evidence). Cognitive behavioural therapy for insomnia is recommended as the first-line treatment for chronic insomnia in adults of any age (strong recommendation, high-quality evidence). A pharmacological intervention can be offered if cognitive behavioural therapy for insomnia is not sufficiently effective or not available. Benzodiazepines, benzodiazepine receptor agonists and some antidepressants are effective in the short-term treatment of insomnia (≤4 weeks; weak recommendation, moderate-quality evidence). Antihistamines, antipsychotics, melatonin and phytotherapeutics are not recommended for insomnia treatment (strong to weak recommendations, low- to very-low-quality evidence). Light therapy and exercise need to be further evaluated to judge their usefulness in the treatment of insomnia (weak recommendation, low-quality evidence). Complementary and alternative treatments (e.g. homeopathy, acupuncture) are not recommended for insomnia treatment (weak recommendation, very-low-quality evidence).
Effectiveness of internet-supported cognitive behavioral and chronobiological interventions and effect moderation by insomnia subtype: study protocol of a randomized controlled trial. [2018]DSM-V criteria for insomnia disorder are met by 6 to 10% of the adult population. Insomnia has severe consequences for health and society. One of the most common treatments provided by primary caregivers is pharmacological treatment, which is far from optimal and has not been recommended since a 2005 consensus report of the National Institutes of Health. The recommended treatment is Cognitive Behavioral Therapy for Insomnia. Effectiveness, however, is still limited. Only a few studies have evaluated the effectiveness of chronobiological treatments, including the timed application of bright light, physical activity and body warming. Another opportunity for optimization of treatment is based on the idea that the people suffering from insomnia most likely represent a heterogeneous mix of subtypes, with different underlying causes and expected treatment responses. The present study aims to evaluate the possibility for optimizing insomnia treatment along the principles of personalized and stratified medicine. It evaluates the following: 1. The relative effectiveness of internet-supported cognitive behavioral therapy, bright light, physical activity and body warming; 2. Whether the effectiveness of internet-supported cognitive behavioral therapy for insomnia can be augmented by simultaneous or prior application of bright light, physical activity and body warming; and 3. Whether the effectiveness of the interventions and their combination are moderated by the insomnia subtype.
Comparative effectiveness and safety of pharmacological and non-pharmacological interventions for insomnia: an overview of reviews. [2023]This review aimed to assess the existing evidence regarding the clinical effectiveness and safety of pharmacological and non-pharmacological interventions in adults with insomnia and identify where research or policy development is needed.
Hypertension with unsatisfactory sleep health (HUSH): study protocol for a randomized controlled trial. [2019]Insomnia is common in primary care medical practices. Although behavioral treatments for insomnia are safe, efficacious, and recommended in practice guidelines, they are not widely-available, and their effects on comorbid medical conditions remain uncertain. We are conducting a pragmatic clinical trial to test the efficacy of two cognitive behavioral treatments for insomnia (Brief Behavioral Treatment for Insomnia (BBTI) and Sleep Healthy Using the Internet (SHUTi)) versus an enhanced usual care condition (EUC).
Smartphone apps for insomnia: examining existing apps' usability and adherence to evidence-based principles for insomnia management. [2019]Insomnia affects up to 22% of the U.S. adult population. The use of mobile health applications (mHealth apps) has been posited as one way to increase access to evidence-based interventions for insomnia, such as cognitive behavioral therapy for insomnia (CBT-I). The purpose of the current study was to summarize the availability of mHealth apps that focus on providing users with the behavioral and/or cognitive skills to manage insomnia, assess their adherence to evidence-based principles, and examine their usability. The terms "insomnia," "insomnia treatment," and "sleep treatment" were used to search the Apple iTunes and Google Play stores in November 2016. Social network query within the authors' professional networks was also conducted. Apps that met inclusion criteria for the study were downloaded and reviewed by the research team for their general characteristics; inclusion of CBT-I skills, strategies, and principles; and aesthetics and usability. Of the 357 apps initially found, 12 met criteria for further review. Overall, the apps were moderately adherent to CBT-I principles, with a mean app score of 1.44 out of 3.00, and moderately usable, with a mean usability score of 3.54 out of 5.00. Few apps currently exist that utilize evidence-based principles to help users practice the behavioral and cognitive skills shown to manage insomnia. Thus, there are exciting opportunities for clinicians, researchers, and mHealth experts to develop effective apps that can help ease the public health burden of insomnia.
Oral nonprescription treatment for insomnia: an evaluation of products with limited evidence. [2008]To evaluate the level of evidence regarding the safety and efficacy of nonprescription therapies used for insomnia.
Smartphone-based virtual agents and insomnia management: A proof-of-concept study for new methods of autonomous screening and management of insomnia symptoms in the general population. [2022]Insomnia is the most frequent sleep disorder, and the COVID-19 crisis has massively increased its prevalence in the population, due to psychosocial stress or direct viral contamination. KANOPEE_2 is a smartphone-based application that provides interactions with a virtual agent to autonomously screen and alleviate insomnia symptoms through an intervention programme giving personalized advices regarding sleep hygiene, relaxation techniques and stimulus-control. In this proof-of-concept study, we tested the effects of KANOPEE_2 among users from all over the country (France) who downloaded the app between 1 June and 26 October 2020 (to focus on effects after the end of COVID-19 confinement). Outcome measures include insomnia severity (Insomnia Severity Index) and sleep/wake schedules measured by a sleep diary. One-thousand and thirty-four users answered the screening interview (Mage  = 43.76 years; SD = 13.14), and 108 completed the two-step programme (Mage  = 46.64 years; SD = 13.63). Of those who answered the screening, 42.8% did not report sleep complaints, while 57.2% presented mild-to-severe insomnia symptoms. At the end of the intervention, users reported significantly fewer sleep complaints compared with the beginning of the intervention (Insomnia Severity Indexbeginning  = 13.58; Insomnia Severity Indexend  = 11.30; p < 0.001), and significantly increased their sleep efficiency (sleep efficiencybeginning  = 76.46%; sleep efficiencyend  = 80.17%; p = 0.013). KANOPEE_2 is a promising solution both to provide autonomous evaluation of individuals' sleep hygiene and reduce insomnia symptoms over a brief and simple intervention. These results are very encouraging for addressing the issue of insomnia management in people exposed to major psychosocial stress and the consequences of COVID-19 infection.
Mobile Phone-Delivered Cognitive Behavioral Therapy for Insomnia: A Randomized Waitlist Controlled Trial. [2018]This study is one of the first randomized controlled trials investigating cognitive behavioral therapy for insomnia (CBT-I) delivered by a fully automated mobile phone app. Such an app can potentially increase the accessibility of insomnia treatment for the 10% of people who have insomnia.
Therapeutic options for sleep-maintenance and sleep-onset insomnia. [2013]Insomnia, defined as difficulty falling asleep, staying asleep, and/or experiencing restorative sleep with associated impairment or significant distress, is a common condition resulting in significant clinical and economic consequences. Many options are available to treat insomnia, to assist with either falling asleep (sleep onset) or maintaining sleep. We searched MEDLINE for articles published between January 1996 and January 2006, evaluated abstracts from recent professional meetings, and contacted the manufacturer of the most recent addition to the pharmacologic armamentarium for insomnia treatment (ramelteon) to gather information. Nonpharmacologic options include stimulus control, sleep hygiene education, sleep restriction, paradoxical intention, relaxation therapy, biofeedback, and cognitive behavioral therapy. Prescription and over-the-counter drug therapies include benzodiazepine and nonbenzodiazepine sedative-hypnotic agents; ramelteon, a melatonin receptor agonist; trazodone; and sedating antihistamines. Herbal and alternative preparations include melatonin and valerian. Before recommending any treatment, clinicians should consider patient-specific criteria such as age, medical history, and other drug use, as well as the underlying cause of the sleep disturbance. All pharmacotherapy should be used with appropriate caution, at minimum effective doses, and for minimum duration of time.