Evaluating a mobile app for chronic insomnia treatment in Italy

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This pilot trial assesses the usability and preliminary effectiveness of a mobile application designed to help individuals with chronic insomnia. The app includes features such as digital sleep diaries, personalized sleep hygiene education, relaxation exercises, and an interactive chatbot. Fifty adult participants diagnosed with chronic insomnia will be randomly assigned to either use the app alongside their usual treatment or receive standard care only. The study aims to determine how well the app can support users in managing their sleep issues over an 8-week period.

Why it matters

Who can join: the full rules

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)

Where it's running

• Ospedale Borgo Roma - Neurologia B
  Verona, Verona, Italy Recruiting

Study contacts

• Study coordinator: Elena Antelmi, Professor - Neurology
• Email: elena.antelmi@univr.it
• Phone: +393293526335

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

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• SleepCogni for children with chronic insomnia

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.