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
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- Usability and Acceptability of Digital Health Technology (DHT)
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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)
排除标准
- •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)
研究组 & 干预措施
Digital Health Technology (DHT) + Treatment As Usual (TAU)
Participants in this arm receive an 8-week intervention involving a mobile app designed for chronic insomnia management. The app includes digital sleep diaries, personalized sleep hygiene education, cognitive strategies, relaxation and mindfulness exercises, and an interactive chatbot for enhanced engagement. This intervention complements standard treatment (TAU), which may include pharmacotherapy and routine clinical care.
干预措施: Digital Health Technology for Chronic Insomnia (Behavioral)
Treatment As Usual (TAU)
Participants assigned to this arm continue their usual insomnia management, including pharmacological treatments if prescribed, and receive standardized educational material on sleep hygiene practices via a printed booklet. They also maintain printed sleep diaries for self-monitoring throughout the 8-week study period.
干预措施: Treatment as Usual (TAU) (Behavioral)
结局指标
主要结局
Usability and Acceptability of Digital Health Technology (DHT)
时间窗: After 8 weeks of intervention (T1)
Usability and acceptability measured by the User Experience Questionnaire (UEQ) and digital engagement metrics, including app access frequency, session duration, notification interactions, and drop-out rates.
Adherence to Sleep Hygiene Practices
时间窗: Baseline (T0), after 8 weeks (T1), and at 6-month follow-up (T2)
Change in adherence to recommended sleep hygiene behaviors assessed through the Sleep Hygiene Index (SHI).
次要结局
- Insomnia Severity Index (ISI)(Baseline (T0), after 8 weeks (T1), and at 6-month follow-up (T2))
- Mood and Emotional Distress(Baseline (T0), after 8 weeks (T1), and at 6-month follow-up (T2))
- Health-Related Quality of Life(Baseline (T0), after 8 weeks (T1), and at 6-month follow-up (T2))
研究者
Elena Antelmi
Associate Professor of Neurology and Clinical Neurologist
Universita di Verona