Assessment of Usability and Preliminary Effectiveness of a Digital Sleep Aid in an Italian Sample

Официальное название

Usability, Acceptability, and Preliminary Effectiveness of a Digital Health Technology for Patient Monitoring of Chronic Insomnia Symptoms and the Promotion of Functional Sleep Behaviors: A Randomized Clinical Trial

Обзор

Chronic insomnia affects approximately 30% of the Italian population, leading to significant impairments in daily functioning and overall health. While Cognitive Behavioral Therapy for Insomnia (CBT-I) is the recommended first-line treatment, access is limited due to a shortage of trained specialists and resources within the Italian healthcare system. This study aims to evaluate the usability, acceptability, and preliminary effectiveness of a mobile application designed to assist individuals with chronic insomnia. The app offers digital sleep diaries, personalized sleep hygiene education, relaxation exercises, and an interactive chatbot to promote healthy sleep behaviors. Fifty adult participants diagnosed with chronic insomnia will be randomly assigned to either the intervention group, which will use the mobile application alongside their usual treatment, or to a control group receiving only standard care. The primary outcomes will assess the app's usability and participants' adherence to sleep hygiene practices. Secondary outcomes will evaluate changes in insomnia severity, mood, and quality of life. Assessments will occur at the start of the study, after the 8-week intervention, and at a 6-month follow-up to explore the intervention's long-term effects.

Подробное описание

This randomized controlled pilot trial evaluates a Digital Health Technology (DHT) developed as a Health \& Wellness tool aimed at supporting individuals diagnosed with chronic insomnia. Chronic insomnia significantly impacts quality of life and poses a considerable burden on healthcare systems. Despite Cognitive Behavioral Therapy for Insomnia (CBT-I) being the recommended first-line treatment, its limited accessibility in Italy necessitates scalable and innovative solutions. The DHT under investigation is a mobile application developed collaboratively by the University of Verona and private-sector partners, designed specifically for educational purposes and the promotion of healthy sleep behaviors.

The intervention is structured over an 8-week period, during which participants are expected to engage daily with the application. The DHT includes several core functionalities:

Digital Sleep Diaries: Participants document their sleep habits daily, including sleep onset latency, total sleep duration, wake after sleep onset, and sleep efficiency. This self-monitoring aims to increase sleep-awareness and encourage consistent engagement with healthy sleep behaviors.

Personalized Educational Content: Users gain access to educational modules designed according to CBT-I principles. Topics include optimizing the sleep environment, maintaining consistent sleep schedules, managing lifestyle factors affecting sleep, and addressing common misconceptions about sleep.

Relaxation and Mindfulness Exercises: The app provides guided audio and video exercises focusing on relaxation techniques such as deep breathing and progressive muscle relaxation, alongside mindfulness practices intended to reduce pre-sleep arousal and facilitate better sleep.

Interactive Chatbot: An integrated conversational agent assists users in navigating app functionalities, provides personalized reminders, motivational feedback, and real-time assistance, enhancing user engagement and compliance.

Participants (N=50) are recruited from the outpatient clinic at Borgo Roma Hospital, Verona. Eligible individuals are randomly assigned in a 1:1 ratio to either receive the DHT intervention combined with Treatment as Usual (DHT + TAU), or Treatment as Usual (TAU) alone. TAU involves standardized educational materials on sleep hygiene practices provided via printed booklets and continued management under the patient's usual healthcare provider.

Assessments are conducted at baseline (T0), immediately post-intervention (T1), and at a 6-month follow-up (T2). Primary outcomes focus on usability and acceptability, measured by the User Experience Questionnaire (UEQ), digital engagement metrics, and adherence to sleep hygiene practices via the Sleep Hygiene Index (SHI). Secondary outcomes assess preliminary efficacy regarding insomnia severity (Insomnia Severity Index - ISI), mood disturbances (Hospital Anxiety and Depression Scale - HADS), and overall health-related quality of life (Short Form Health Survey - SF-12).

Data collection employs the secure LimeSurvey platform to ensure participant confidentiality and data protection according to GDPR standards. Data analysis includes Linear Mixed Effects Models, exploratory analyses for identifying predictors of treatment response, and sensitivity analyses for assessing robustness of findings.

This feasibility trial aims to inform future large-scale studies by evaluating the potential benefits and limitations of using a scalable, non-medical DHT in the routine management of chronic insomnia. Results are anticipated to contribute substantially to the evidence base supporting digital interventions as viable adjuncts to standard care for insomnia.

Вмешательства

• Поведенческое Digital Health Technology for Chronic Insomnia
  A mobile application designed to support chronic insomnia management through digital self-monitoring of sleep patterns, personalized sleep hygiene education, cognitive strategies, relaxation and mindfulness exercises, and chatbot interactions. Users receive tailored notifications and educational content to encourage healthy sleep behaviors over an 8-week period. Existing pharmacological treatments prescribed prior to study enrollment continue unchanged
• Поведенческое Treatment as Usual (TAU)
  Participants receive standard sleep hygiene recommendations via a printed educational booklet. They maintain printed sleep diaries for daily self-monitoring throughout the 8-week intervention. Existing pharmacological treatments prescribed prior to study enrollment continue unchanged.

Первичные конечные точки

• Usability and Acceptability of Digital Health Technology (DHT) [Срок оценки: After 8 weeks of intervention (T1)]
• Adherence to Sleep Hygiene Practices [Срок оценки: Baseline (T0), after 8 weeks (T1), and at 6-month follow-up (T2)]

Вторичные конечные точки (3)

• Insomnia Severity Index (ISI) [Срок оценки: Baseline (T0), after 8 weeks (T1), and at 6-month follow-up (T2)]
• Mood and Emotional Distress [Срок оценки: Baseline (T0), after 8 weeks (T1), and at 6-month follow-up (T2)]
• Health-Related Quality of Life [Срок оценки: Baseline (T0), after 8 weeks (T1), and at 6-month follow-up (T2)]

Критерии участия

Критерии включения

• Adults aged 18 to 70 years
• Diagnosis of chronic insomnia according to DSM-5 criteria
• Willingness to participate in the study and provide informed consent
• Personal active email address
• Ownership of a compatible mobile device with internet access (for the DHT group)

Критерии исключения

• Medical conditions requiring hospital admission during the study period
• Comorbid diagnosis of sleep-related breathing disorders
• Neurological disorders affecting sleep (e.g., narcolepsy, parasomnias, epilepsy, neurodegenerative diseases)
• Currently receiving psychological treatment for insomnia or planning to do so within the next 6 months
• Incompatible smartphone or lack of internet access (for DHT group)

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Открытое

Основная цель

Поддерживающая терапия

Центры проведения

Италия · 1 центр

• Ospedale Borgo Roma - Neurologia B — Verona

Публикации

• Zigmond AS, Snaith RP. The hospital anxiety and depression scale. Acta Psychiatr Scand. 1983 Jun;67(6):361-70. doi: 10.1111/j.1600-0447.1983.tb09716.x. PMID 6880820
• Watanabe Y, Kuroki T, Ichikawa D, Ozone M, Uchimura N, Ueno T. Effect of smartphone-based cognitive behavioral therapy app on insomnia: a randomized, double-blind study. Sleep. 2023 Mar 9;46(3):zsac270. doi: 10.1093/sleep/zsac270. PMID 36355920
• Terzano MG, Parrino L, Cirignotta F, Ferini-Strambi L, Gigli G, Rudelli G, Sommacal S; Studio Morfeo Committee. Studio Morfeo: insomnia in primary care, a survey conducted on the Italian population. Sleep Med. 2004 Jan;5(1):67-75. doi: 10.1016/j.sleep.2003.09.006. PMID 14725829
• Stepanski EJ, Wyatt JK. Use of sleep hygiene in the treatment of insomnia. Sleep Med Rev. 2003 Jun;7(3):215-25. doi: 10.1053/smrv.2001.0246. PMID 12927121
• Spielman AJ, Caruso LS, Glovinsky PB. A behavioral perspective on insomnia treatment. Psychiatr Clin North Am. 1987 Dec;10(4):541-53. PMID 3332317
• Shapiro SL, Carlson LE, Astin JA, Freedman B. Mechanisms of mindfulness. J Clin Psychol. 2006 Mar;62(3):373-86. doi: 10.1002/jclp.20237. PMID 16385481
• Shamim SA, Warriach ZI, Tariq MA, Rana KF, Malik BH. Insomnia: Risk Factor for Neurodegenerative Diseases. Cureus. 2019 Oct 26;11(10):e6004. doi: 10.7759/cureus.6004. PMID 31807391
• Schuffelen J, Maurer LF, Lorenz N, Rotger A, Pietrowsky R, Gieselmann A. The clinical effects of digital cognitive behavioral therapy for insomnia in a heterogenous study sample: results from a randomized controlled trial. Sleep. 2023 Nov 8;46(11):zsad184. doi: 10.1093/sleep/zsad184. PMID 37428712

Идентификаторы

NCT: NCT06926348 · 413CET

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

Открыть это исследование на ClinicalTrials.gov ↗