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Search / Trial NCT06926348

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

Launched by UNIVERSITA DI VERONA · Apr 6, 2025

Trial Information

Current as of May 29, 2025

Recruiting

Keywords

Insomnia Cbt I Cognitive Behavioral Therapy For Insomnia Digital Health Technology D Tx

ClinConnect Summary

This clinical trial is studying a new mobile application designed to help adults with chronic insomnia, a condition that affects many people and can significantly impact daily life and health. The app includes features like digital sleep diaries, personalized tips for better sleep, relaxation exercises, and a chatbot to support healthy sleep habits. The goal is to see how well the app works, how easy it is to use, and if it helps improve sleep quality and overall well-being compared to standard care alone.

To participate in this study, you need to be between 18 and 70 years old and diagnosed with chronic insomnia. You'll also need a smartphone with internet access and must be willing to provide informed consent to join the trial. If you qualify, you will be randomly assigned to either use the app alongside your usual treatment or receive standard care only. The study lasts for 8 weeks, and follow-ups will be conducted to check on your progress and the app's long-term effects. This is a great opportunity to potentially improve your sleep with a new tool while contributing to important research in sleep health!

Gender

ALL

Eligibility criteria

  • Inclusion Criteria:
  • 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)
  • Exclusion Criteria:
  • 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)

About Universita Di Verona

The Università di Verona is a prestigious academic institution in Italy, renowned for its commitment to advancing medical research and education. With a focus on innovative clinical trials, the university collaborates with various healthcare professionals and institutions to explore new therapies and improve patient outcomes. Its research initiatives are driven by a multidisciplinary approach, leveraging cutting-edge technology and methodologies. The Università di Verona aims to contribute significantly to the scientific community and public health by fostering rigorous clinical studies that address pressing medical challenges.

Locations

Verona, , Italy

Patients applied

0 patients applied

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported