What is this study trying to find out about chronic insomnia?

This study is evaluating a mobile app designed to support people with chronic insomnia by promoting healthy sleep habits and monitoring sleep patterns. Researchers want to understand if the app is easy to use, acceptable to patients, and can help improve sleep and related wellbeing. The study is sponsored by the University of Verona and aims to explore new digital tools for insomnia care.

Who may be eligible for this chronic insomnia clinical trial?

Adults aged 18 to 70 years with a diagnosis of chronic insomnia may be eligible. Participants should have a personal email address and, if assigned to the app group, a compatible smartphone with internet access. People currently receiving psychological treatment for insomnia or with certain medical conditions are excluded. Please review eligibility criteria for more details.

Is there any cost to participate in this chronic insomnia clinical trial?

Study-related care, including the study app or printed materials and all trial visits, is provided at no cost. Personal travel or other expenses are not guaranteed to be covered and may vary depending on the participant. Participants should plan accordingly for any costs outside of study procedures.

Actively Recruiting

Phase Not Applicable

Age: 18Years - 70Years

All Genders

ID06926348

Evaluating a Mobile App to Support Adults With Chronic Insomnia Using Digital Sleep Tools and Personalized Sleep Education A Randomized Study in Italy

Led by Universita di Verona · Updated on 2025-04-17

Participants Needed

Research Sites

22 weeks

Total Duration

AI-Summary

What this Trial Is About

Chronic insomnia affects about 30% of the Italian population and can significantly impair daily life and health. Cognitive Behavioral Therapy for Insomnia CBT-I is the preferred treatment, but limited access to trained specialists in Italy has created a need for new solutions. This trial evaluates a mobile app designed to support people with chronic insomnia by promoting healthy sleep habits and monitoring sleep patterns. The study is a randomized controlled pilot trial involving 50 adults diagnosed with chronic insomnia. Participants are randomly assigned to one of two groups the intervention group uses the mobile app alongside their usual treatment, and the control group receives standard care alone. The mobile app includes daily digital sleep diaries, personalized sleep hygiene education based on CBT-I, relaxation and mindfulness exercises, and an interactive chatbot to encourage engagement. The intervention lasts 8 weeks, with the control group receiving printed educational booklets and self-monitoring diaries. Participants will be assessed at the start of the study, immediately after the 8-week intervention, and again at a 6-month follow-up. Researchers will measure the apps usability, participants adherence to sleep hygiene practices, and changes in insomnia severity, mood, and quality of life. Data collection is conducted securely online to protect privacy. This study aims to determine if this digital health tool could be a helpful addition to standard insomnia care and guide larger future studies.

CONDITIONS

Brief Title

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

Who Can Participate

Age: 18Years - 70Years

All Genders

Eligibility Criteria

You may qualify if you...

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)

You will not qualify if you...

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)

Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person)

Outpatient Treatment

Duration - 8 weeks

Participants engage in an 8-week behavioral intervention for chronic insomnia. Those in the experimental group use a mobile application daily that includes digital sleep diaries, personalized sleep hygiene education, relaxation and mindfulness exercises, and an interactive chatbot. Participants in the comparator group receive standard care with printed educational materials and maintain printed sleep diaries. Existing pharmacological treatments continue unchanged.

Daily self-monitoring with either app or printed diaries during the 8 weeks

Follow-up

Duration - 6 months

Participants complete assessments to evaluate adherence to sleep hygiene practices, insomnia severity, mood, and quality of life at 6 months after the intervention ends.

1 follow-up assessment